B-Cell Non-Hodgkin LymphomaEarly Phase 1GI001-01NCT07862010
Study of GI001 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
A Early Phase 1 study testing GI001 in people with B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia, run by Hematology department of the 920th hospital at 1 site in China.
Trial summary
This is an open-label, multi-cohort, investigator-initiated clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of GI001 in adult patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (R/R B-NHL) and B-cell Acute Lymphoblastic Leukemia (R/R B-ALL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-Cell Non-Hodgkin Lymphoma, B-Cell Acute Lymphoblastic Leukemia
- What is being tested?
- GI001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2025to Nov 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18 to 75 years, inclusive.
- 2. Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) or R/R B-cell acute lymphoblastic leukemia (B-ALL):
- 2.1 CD19-positive R/R B-NHL meeting the following:
- Histopathologic diagnosis of indolent NHL (iNHL), including but not limited to follicular lymphoma (FL) and marginal zone lymphoma (MZL), or small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL); or aggressive B-cell lymphoma, including but not limited to diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-cell/histiocyte-rich large B-cell lymphoma (TCRBCL).
- Refractory disease defined as: (a) best response of progressive disease (PD) to first-line standard therapy, or stable disease (SD) after at least 4 cycles of first-line therapy with SD duration not exceeding 6 months after the last treatment; or (b) no response to second-line or later therapy, including best response of PD to the most recent therapy, or SD after at least 2 cycles of the most recent therapy with SD duration not exceeding 6 months after the last treatment; or (c) disease progression within 12 months after autologous hematopoietic stem cell transplantation (ASCT) or biopsy-confirmed relapse, or no remission or relapse (SD or PD) after salvage therapy following ASCT.
- Relapse defined as PD after achieving a response (partial response [PR] or complete response [CR]) to adequate prior therapy.
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- Note: participants must have received adequate prior therapy; participants with CD20-positive disease must have failed or relapsed after anti-CD20 monoclonal antibody therapy.
- 2.2 CD19-positive R/R B-ALL meeting the following:
- Relapse defined as: (a) hematologic relapse: reappearance of blasts (>=5%) in peripheral blood or bone marrow, or extramedullary disease, in a participant who had achieved CR; or (b) molecular relapse: reappearance of measurable residual disease (MRD) positivity after hematologic CR (HCR) and CR MRD negativity, with an increase in MRD level of >=1 log between two positive specimens.
- Refractory disease defined as: (a) failure to achieve CR after at least 2 cycles of standard chemotherapy, or late relapse (>=12 months) after CR with failure to achieve CR after at least 1 additional cycle; or (b) relapse after hematopoietic stem cell transplantation, or failure to achieve remission with the last therapy in participants receiving salvage therapy after HSCT; or (c) failure to achieve CR or relapse after at least 2 tyrosine kinase inhibitors (TKIs) (participants with TKI-resistance mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, or F359V/C/I are not required to have received at least 2 TKIs), or intolerance to or contraindication for TKIs, in Philadelphia chromosome-positive (Ph+) B-ALL.
- 2.3 Participants who are not eligible for stem cell transplantation, or whose medical records document refusal of other available therapies, may also be enrolled.
- 3. CD19 expression positivity confirmed by immunohistochemistry (IHC) or flow cytometry (FACS) on tumor specimen, bone marrow, or peripheral blood at screening.
- 4. Measurable disease per Lugano 2014 criteria for B-NHL participants (nodal lesion LDi > 1.5 cm, extranodal lesion LDi > 1.0 cm); bone marrow blasts and immature lymphocytes >=5% for B-ALL participants at screening.
- 5. ECOG performance status 0 to 2.
- 6. Expected survival >=12 weeks.
- 7. Adequate organ function meeting all of the following laboratory results before enrollment:
- Hematology: bone marrow reserve for R/R B-NHL participants must meet: absolute neutrophil count (ANC) > 0.5 x 10^9/L (no short-acting G-CSF within 7 days and no long-acting G-CSF within 14 days before testing); absolute lymphocyte count (ALC) >= 0.5 x 10^9/L; platelet count >= 30 x 10^9/L (no platelet transfusion within 7 days before testing); hemoglobin >= 80 g/L (no red blood cell transfusion within 7 days before testing; recombinant erythropoietin permitted). All participants (B-NHL and B-ALL) require absolute CD3+ T cell count >= 150/uL.
- Hepatic: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x upper limit of normal (ULN); total serum bilirubin <= 2 x ULN.
- Renal: creatinine clearance (CrCl) >= 60 mL/min (Cockcroft-Gault formula).
- Coagulation: fibrinogen >= 1.0 g/L; activated partial thromboplastin time <= 1.5 x ULN; prothrombin time (PT) <= 1.5 x ULN.
- Cardiac: left ventricular ejection fraction (LVEF) >= 55%; oxygen saturation > 91%.
- 8. Therapeutic-dose steroids must be discontinued 72 hours before GI001 infusion (physiologic replacement-dose steroids are permitted).
- 9. CNS disease prophylaxis (e.g., intrathecal methotrexate) must be discontinued 1 week before GI001 infusion.
- 10. Participants and their partners agree to use effective barrier or pharmacologic contraception (excluding calendar/rhythm methods) from the time of informed consent through 1 year after GI001 administration.
- 11. Written informed consent approved by the ethics committee must be obtained before initiating any screening procedures.
Who cannot join
- 1. Prior antitumor therapy as follows (except agents proven to enhance CAR-T cell efficacy or not to affect CAR-T cells, after an appropriate washout period):
- Cytotoxic chemotherapy within 2 weeks before dosing.
- Small molecule targeted therapy within 2 weeks before dosing.
- Antibody therapy within 3 weeks before dosing.
- Pegylated asparaginase within 4 weeks before dosing.
- Immunosuppressive therapy within 4 weeks before dosing or requirement for long-term immunosuppression.
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- Radiotherapy within 4 weeks before dosing.
- Bendamustine within 6 months before dosing.
- Prior treatment with any gene therapy product, including CAR-T therapy (except participants with no in vivo CAR-T, normal T cell count and function, and CD19-positive tumor).
- Prior treatment with any anti-CD19/anti-CD3 therapy or any other anti-CD19 therapy (except participants with normal T cell count and function and CD19-positive tumor).
- Other investigational drugs or other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) before dosing.
- 2. Other malignancy within 2 years before screening, excluding adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical prostatectomy, ductal carcinoma in situ of the breast after radical surgery, and papillary thyroid carcinoma after radical treatment.
- 3. History of solid organ transplantation.
- 4. Use of immunomodulatory agents within 2 weeks before dosing, or likely use during the study, including but not limited to thalidomide, lenalidomide, and pomalidomide.
- 5. Requirement for long-term therapeutic-dose corticosteroids (defined as prednisone or equivalent > 15 mg/day); physiologic replacement, topical, and inhaled use are permitted.
- 6. Prior or current CNS involvement or suspected CNS involvement: leukemia or lymphoma cells detected in cerebrospinal fluid (CSF); or imaging findings of mass, thickening, or enhancement in brain parenchyma, meninges, cranial nerves, or spinal cord supporting a diagnosis of CNS involvement; or neurologic signs or symptoms with abnormal CSF findings suggestive of CNS involvement.
- 7. Hypertension not controllable with medication.
- 8. Severe cardiac disease, including but not limited to: myocardial infarction within 6 months before screening; coronary artery bypass grafting or coronary stent placement within 6 months before screening; unstable angina; congestive heart failure (New York Heart Association class >= III); severe arrhythmia; history of severe non-ischemic cardiomyopathy.
- 9. Unstable systemic disease as judged by the investigator, including but not limited to severe hepatic, renal, or metabolic disease requiring medication.
- 10. Uncontrolled active bacterial, fungal, viral, or other infection, or infection requiring intravenous anti-infective therapy (uncontrolled infection defined as persistent infection-related signs or symptoms without improvement after appropriate anti-infective therapy).
- 11. Stroke, seizure, or other CNS disease unsuitable for this study within 6 months before screening; uncontrolled psychiatric disorder; or any medical or psychiatric history that in the investigator's judgment may increase the risk of study participation or dosing, or may interfere with study results.
- 12. History of deep vein thrombosis or pulmonary embolism within 6 months before screening.
- 13. Live vaccine within 6 weeks before screening.
- 14. Major surgery within 2 weeks before screening, or planned surgery within 2 weeks after dosing (excluding surgery under local anesthesia).
- 15. Pregnant or breastfeeding women, or women planning pregnancy during or after treatment.
- 16. Non-hematologic toxicity from prior therapy not resolved to baseline or <= grade 2 (excluding alopecia, fatigue, and peripheral neuropathy).
- 17. Prior treatment with a therapeutic pseudotyped with vesicular stomatitis virus glycoprotein (VSVG) or Nipah virus.
- 18. Positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with hepatitis B virus DNA (HBV-DNA) above the lower limit of detection; positive hepatitis C virus (HCV) antibody with HCV-RNA above the lower limit of detection; positive human immunodeficiency virus (HIV) antibody; or positive syphilis serology.
- 19. Isolated extramedullary relapse of B-ALL.
- 20. Hypersensitivity to the investigational drug or its excipients, or to tocilizumab.
- 21. Primary immunodeficiency.
- 22. Planned hematopoietic stem cell transplantation within 28 days after GI001 infusion.
- 23. Any other condition that in the investigator's judgment makes the participant unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The 920th Hospital of Joint Logistics Support Force, PLA
Yunnan, Kunming
Sanbing Wang, +86 871 64788278, wangsanbin2022@126.com
Sanbing Wang
About this study
Official title: An Exploratory Clinical Study Evaluating GI001 in the Treatment of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
This is an open-label, multi-cohort, investigator-initiated clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of GI001 in adult patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (R/R B-NHL) and B-cell Acute Lymphoblastic Leukemia (R/R B-ALL).
GI001 is an exploratory, in vivo chimeric antigen receptor T-cell (CAR-T) therapy targeting the CD19 antigen. Unlike traditional CAR-T cell therapies that require extensive in vitro cell manufacturing, GI001 is administered directly to the patient via intravenous infusion, aiming to generate CAR-T cells directly within the patient's body.
Read more
The study consists of two main phases:
- Dose-Escalation Phase: This phase will evaluate four ascending dose levels to assess safety, identify any Dose-Limiting Toxicities (DLTs), determine the Maximum Tolerated Dose (MTD), and establish the Recommended Dose for Expansion (RDE). It utilizes an accelerated titration design for the initial doses, followed by a standard "3+3" dose-escalation design.
- Dose-Expansion Phase ： Once the RDE is identified, additional patients will be enrolled to further evaluate the safety, clinical efficacy, pharmacokinetics, and pharmacodynamics of GI001 at the selected dose(s).
The primary focus of the study is to continuously monitor adverse events and evaluate the overall safety profile. Secondary objectives include assessing clinical response rates (such as Objective Response Rate and Complete Response Rate), survival outcomes, and the expansion levels of CAR-T cells in the peripheral blood.
Read the detailed description
This is an open-label, multi-cohort, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and preliminary efficacy of GI001 in adult patients with R/R B-NHL and R/R B-ALL. The study is divided into a Dose-Escalation Phase and a potential Dose-Expansion Phase.
Dose-Escalation Phase
- The dose-escalation phase evaluates four dose levels: 1 x 10E8 TU, 4 x 10E8 TU, 1.2 x 10E9 TU, and 2.4 x 10E9 TU.
- Cohorts 1 and 2 utilize an accelerated titration design, initially enrolling 1 subject per cohort.
- If a Dose-Limiting Toxicity (DLT), $\ge$ Grade 2 non-hematologic toxicity (occurring $\ge$ 2 times), or evidence of excessive CAR-T expansion occurs, the cohort switches to a standard "3+3" design.
- Cohorts 3 and 4 follow a standard "3+3" escalation rule based on the occurrence of DLTs during a 28-day observation period.
- A Safety Review Committee (SRC) will evaluate the safety data to determine dose escalation, Maximum Tolerated Dose (MTD), and Recommended Dose for Expansion (RDE).
Dose-Expansion Phase
- If applicable, 1 to 2 dose levels from the escalation phase will be selected as the RDE.
- Approximately 12 to 18 additional subjects will be enrolled to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).
Study Procedures
- Screening and Baseline: Eligible subjects undergo screening (Day -30 to Day -3) and baseline assessments (Day -2 to Day -1) to confirm eligibility and establish baseline status.
- Treatment Administration: Subjects may receive premedication (e.g., promethazine or diphenhydramine) 15 to 30 minutes prior to infusion. GI001 is administered via a single intravenous infusion (lasting up to 2 hours) on Day 0.
- Observation Period: Subjects will be hospitalized for at least 14 days post-infusion for close safety monitoring. The DLT observation period spans 28 days (Day 1 to Day 28).
- Follow-up: Short-term follow-up continues until Day 90, followed by efficacy and safety evaluations every 3 months until Month 12, and then every 6 months until Month 24.
- Long-Term Follow-up: After the 2-year period, subjects enter a 15-year long-term follow-up phase to monitor survival, delayed toxicities, and replication-competent lentivirus (RCL) risk.
- Being tested
- GI001
- Keywords
- GI001, CD19, CAR-T, In vivo CAR-T
- Medical subject headings
- Lymphoma, B-Cell, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI001Biological
GI001 is an in vivo CD19-targeted CAR-T therapy. It is a lentiviral vector-based product using a third-generation self-inactivating lentiviral vector system with a five-plasmid packaging design. GI001 is administered by intravenous injection and delivers the CD19 CAR gene directly into the patient, reprogramming the patient's own T cells in situ to express CD19 CAR without ex vivo cell manufacturing. No lymphodepleting conditioning is required, and a single injection is given. GI001 is supplied as a colorless to slightly opaque liquid, 1 mL per vial, stored at -70 +/- 10 degrees C. Infusion duration does not exceed 2 hours. Dose levels evaluated in this study are 3.5x10^8 TU, 7.0x10^8 TU and 1.0x10^9 TU (TU = transducing units). Recommended premedication is intramuscular promethazine 25 mg or diphenhydramine 20 mg given 15-30 minutes before infusion. Dose modification is not permitted (a +/-20% dose range is acceptable).
| Study group | Role | What they receive |
|---|---|---|
| Dose Level -1: GI001 3.5x10^8 TU | Experimental | Single intravenous infusion of GI001, an in vivo CD19-targeted CAR-T therapy, at dose level -1 (3.5x10^8 TU; TU = transducing units). Premedication with intramuscular promethazine 25 mg or diphenhydramine 20 mg is recommended 15-30 minutes before infusion. Infusion duration does not exceed 2 hours. No lymphodepleting conditioning is specified in the protocol. This dose level is explored only if a safety signal is observed at the starting dose. Receives: Biological: GI001 |
| Dose Level 1: GI001 7.0x10^8 TU | Experimental | Single intravenous infusion of GI001, an in vivo CD19-targeted CAR-T therapy, at dose level 1 (7.0x10^8 TU), the starting dose. Premedication with intramuscular promethazine 25 mg or diphenhydramine 20 mg is recommended 15-30 minutes before infusion. Infusion duration does not exceed 2 hours. No lymphodepleting conditioning is specified in the protocol. Enrollment follows a 3+3 dose-escalation design: the first participant is observed for at least 2 weeks before the next participants are enrolled. Receives: Biological: GI001 |
| Dose Level 2: GI001 1.0x10^9 TU | Experimental | Single intravenous infusion of GI001, an in vivo CD19-targeted CAR-T therapy, at dose level 2 (1.0x10^9 TU). Premedication with intramuscular promethazine 25 mg or diphenhydramine 20 mg is recommended 15-30 minutes before infusion. Infusion duration does not exceed 2 hours. No lymphodepleting conditioning is specified in the protocol. Escalation to this dose level occurs if no DLT is observed at the previous dose level. Receives: Biological: GI001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Incidence, severity, seriousness, and relationship to GI001 of treatment-emergent adverse events and serious adverse events. Severity graded per NCI CTCAE v6.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) graded per ASTCT 2019 consensus criteria; immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) graded per ASTCT 2023 criteria.
Measured: From baseline through 2 years after GI001 administration
Change from baseline in body temperature
Change from baseline in body temperature, measured in degrees Celsius, at each scheduled post-dose assessment.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Percentage of participants with dose-limiting toxicities (DLTs)
Percentage of participants in the DLT analysis set who experience at least one protocol-defined DLT within 28 days after GI001 administration. The analysis set includes participants who complete DLT assessment or experience a DLT during the assessment period. DLTs are treatment-related toxicities defined in Protocol Section 4.1.4, including qualifying cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, infusion-related hypersensitivity, non-hematologic toxicities, neutropenia with severe infection, thrombocytopenia with qualifying bleeding, and grade 5 toxicity. Protocol-specified severity thresholds, recovery criteria, and exclusions apply. The number and percentage of participants with DLTs will be summarized.
Measured: From GI001 administration through 28 days after administration
Maximum tolerated dose (MTD)
The highest GI001 dose level, expressed in transducing units (TU), at which no more than 1 of 6 evaluable participants experiences a protocol-defined dose-limiting toxicity (DLT) during the 28-day observation period after administration. If only 3 participants have been enrolled at the candidate MTD, 3 additional participants are enrolled for confirmation. The MTD is determined from the dose-escalation cohort data.
Measured: From GI001 administration through 28 days after administration for each participant in the dose-escalation phase
Recommended dose for expansion (RDE)
GI001 dose level(s), expressed in transducing units (TU), selected for expansion by the Safety Review Committee based on available safety, tolerability, preliminary efficacy, pharmacokinetic, pharmacodynamic, and immunogenicity data from the dose-escalation phase.
Measured: From GI001 administration through 90 days after administration for each participant in the dose-escalation phase
Change from baseline in systolic blood pressure
Change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg), at each scheduled post-dose assessment.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in pulse rate
Change from baseline in pulse rate, measured in beats per minute, at each scheduled post-dose assessment.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in respiratory rate
Change from baseline in respiratory rate, measured in breaths per minute, at each scheduled post-dose assessment.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in ECOG performance status score
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status score at each scheduled post-dose assessment. Scores range from 0 (fully active) to 5 (death), with higher scores indicating worse performance status.
Measured: Baseline and Days 14, 28, 60, and 90, and Months 6, 9, 12, 18, and 24 after GI001 administration
Change from baseline in heart rate measured by 12-lead ECG
Change from baseline in heart rate, measured in beats per minute by 12-lead electrocardiogram (ECG), at each scheduled post-dose assessment. After at least 10 minutes of rest, three measurements are obtained within 5 minutes and averaged.
Measured: Baseline and Days 14, 28, 60, and 90, and Months 6, 9, 12, 18, and 24 after GI001 administration
Change from baseline in PR interval measured by 12-lead ECG
Change from baseline in PR interval, measured in milliseconds by 12-lead electrocardiogram (ECG), at each scheduled post-dose assessment. After at least 10 minutes of rest, three measurements are obtained within 5 minutes and averaged.
Measured: Baseline and Days 14, 28, 60, and 90, and Months 6, 9, 12, 18, and 24 after GI001 administration
Change from baseline in R-R interval measured by 12-lead ECG
Change from baseline in R-R interval, measured in milliseconds by 12-lead electrocardiogram (ECG), at each scheduled post-dose assessment. After at least 10 minutes of rest, three measurements are obtained within 5 minutes and averaged.
Measured: Baseline and Days 14, 28, 60, and 90, and Months 6, 9, 12, 18, and 24 after GI001 administration
Change from baseline in diastolic blood pressure
Change from baseline in diastolic blood pressure, measured in millimeters of mercury (mmHg), at each scheduled post-dose assessment.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in QRS duration measured by 12-lead ECG
Change from baseline in QRS duration, measured in milliseconds by 12-lead electrocardiogram (ECG), at each scheduled post-dose assessment. After at least 10 minutes of rest, three measurements are obtained within 5 minutes and averaged.
Measured: Baseline and Days 14, 28, 60, and 90, and Months 6, 9, 12, 18, and 24 after GI001 administration
Change from baseline in QT interval measured by 12-lead ECG
Change from baseline in QT interval, measured in milliseconds by 12-lead electrocardiogram (ECG), at each scheduled post-dose assessment. After at least 10 minutes of rest, three measurements are obtained within 5 minutes and averaged.
Measured: Baseline and Days 14, 28, 60, and 90, and Months 6, 9, 12, 18, and 24 after GI001 administration
Change from baseline in QTcF interval measured by 12-lead ECG
Change from baseline in QT interval corrected for heart rate using the Fridericia formula (QTcF), measured in milliseconds by 12-lead electrocardiogram (ECG), at each scheduled post-dose assessment. QTcF = QT / (RR in seconds)^(1/3). After at least 10 minutes of rest, three measurements are obtained within 5 minutes and averaged.
Measured: Baseline and Days 14, 28, 60, and 90, and Months 6, 9, 12, 18, and 24 after GI001 administration
Number of participants by change from baseline in physical examination findings
Physical examination findings are classified as normal or abnormal by the investigator. The number of participants in each baseline-to-post-dose category (normal to normal, normal to abnormal, abnormal to normal, or abnormal to abnormal) will be summarized by examined body system and scheduled visit. Examinations cover the head, eyes, ears, nose, throat, neck, heart, chest including lungs, abdomen, extremities, skin, lymph nodes, nervous system, and general condition. Post-dose examinations may focus on clinically indicated organs and systems, as specified in the protocol.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Number of participants by change from baseline in overall 12-lead ECG assessment
The overall 12-lead electrocardiogram (ECG) assessment is classified as normal or abnormal by the investigator. The number of participants in each baseline-to-post-dose category (normal to normal, normal to abnormal, abnormal to normal, or abnormal to abnormal) will be summarized at each scheduled post-dose assessment. This outcome describes the overall ECG interpretation; quantitative ECG parameters are reported separately.
Measured: Baseline and Days 14, 28, 60, and 90, and Months 6, 9, 12, 18, and 24 after GI001 administration
Change from baseline in red blood cell count
Change from baseline in red blood cell count, measured in 10^12/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in hemoglobin concentration
Change from baseline in hemoglobin concentration, measured in g/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in hematocrit
Change from baseline in hematocrit, measured in %, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall. Changes are expressed in percentage points.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in white blood cell count
Change from baseline in white blood cell count, measured in 10^9/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in platelet count
Change from baseline in platelet count, measured in 10^9/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in absolute neutrophil count
Change from baseline in absolute neutrophil count, measured in 10^9/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in absolute lymphocyte count
Change from baseline in absolute lymphocyte count, measured in 10^9/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in absolute monocyte count
Change from baseline in absolute monocyte count, measured in 10^9/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in absolute eosinophil count
Change from baseline in absolute eosinophil count, measured in 10^9/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in absolute basophil count
Change from baseline in absolute basophil count, measured in 10^9/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in neutrophil percentage
Change from baseline in neutrophil percentage, measured in %, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall. Changes are expressed in percentage points.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in lymphocyte percentage
Change from baseline in lymphocyte percentage, measured in %, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall. Changes are expressed in percentage points.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in monocyte percentage
Change from baseline in monocyte percentage, measured in %, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall. Changes are expressed in percentage points.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in eosinophil percentage
Change from baseline in eosinophil percentage, measured in %, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall. Changes are expressed in percentage points.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in basophil percentage
Change from baseline in basophil percentage, measured in %, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall. Changes are expressed in percentage points.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in alanine aminotransferase (ALT)
Change from baseline in alanine aminotransferase (ALT), measured in U/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in aspartate aminotransferase (AST)
Change from baseline in aspartate aminotransferase (AST), measured in U/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in gamma-glutamyl transferase (GGT)
Change from baseline in gamma-glutamyl transferase (GGT), measured in U/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in alkaline phosphatase (ALP)
Change from baseline in alkaline phosphatase (ALP), measured in U/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in lactate dehydrogenase (LDH)
Change from baseline in lactate dehydrogenase (LDH), measured in U/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in creatine kinase (CK)
Change from baseline in creatine kinase (CK), measured in U/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in creatine kinase-MB (CK-MB) activity
Change from baseline in creatine kinase-MB (CK-MB) activity, measured in U/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in total bilirubin
Change from baseline in total bilirubin, measured in micromol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in direct bilirubin
Change from baseline in direct bilirubin, measured in micromol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in creatinine
Change from baseline in creatinine, measured in micromol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in uric acid
Change from baseline in uric acid, measured in micromol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in glucose
Change from baseline in glucose, measured in mmol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in urea
Change from baseline in urea, measured in mmol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in potassium
Change from baseline in potassium, measured in mmol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in sodium
Change from baseline in sodium, measured in mmol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in chloride
Change from baseline in chloride, measured in mmol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in inorganic phosphorus
Change from baseline in inorganic phosphorus, measured in mmol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in total protein
Change from baseline in total protein, measured in g/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in albumin
Change from baseline in albumin, measured in g/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in globulin
Change from baseline in globulin, measured in g/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in albumin-to-globulin ratio
Change from baseline in albumin-to-globulin ratio, measured in unitless, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in prothrombin time (PT)
Change from baseline in prothrombin time (PT), measured in seconds, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in activated partial thromboplastin time (APTT)
Change from baseline in activated partial thromboplastin time (APTT), measured in seconds, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in thrombin time (TT)
Change from baseline in thrombin time (TT), measured in seconds, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in fibrinogen
Change from baseline in fibrinogen, measured in g/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in international normalized ratio (INR)
Change from baseline in international normalized ratio (INR), measured in unitless, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in urine pH
Change from baseline in urine pH, measured in pH units, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in urine white blood cell count
Change from baseline in urine white blood cell count, measured in cells/microliter, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in urine red blood cell count
Change from baseline in urine red blood cell count, measured in cells/microliter, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in magnesium
Change from baseline in magnesium, measured in mmol/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in troponin concentration measured by chemiluminescence immunoassay
Change from baseline in troponin concentration measured by chemiluminescence immunoassay, measured in ng/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Change from baseline in D-dimer
Change from baseline in D-dimer, measured in mg/L, at each scheduled post-dose laboratory assessment. Change is calculated as the post-dose value minus the baseline value and summarized descriptively by dose level and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Number of participants by change from baseline in urine protein category
Number of participants in each baseline-to-post-dose category of urine protein at each scheduled laboratory assessment. Categories are the qualitative or semiquantitative results reported by the laboratory. Results are summarized as participant counts by baseline category, post-dose category, scheduled visit, and dose level, and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Number of participants by change from baseline in urine glucose category
Number of participants in each baseline-to-post-dose category of urine glucose at each scheduled laboratory assessment. Categories are the qualitative or semiquantitative results reported by the laboratory. Results are summarized as participant counts by baseline category, post-dose category, scheduled visit, and dose level, and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Number of participants by change from baseline in urine ketones category
Number of participants in each baseline-to-post-dose category of urine ketones at each scheduled laboratory assessment. Categories are the qualitative or semiquantitative results reported by the laboratory. Results are summarized as participant counts by baseline category, post-dose category, scheduled visit, and dose level, and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Number of participants by change from baseline in urine urobilinogen category
Number of participants in each baseline-to-post-dose category of urine urobilinogen at each scheduled laboratory assessment. Categories are the qualitative or semiquantitative results reported by the laboratory. Results are summarized as participant counts by baseline category, post-dose category, scheduled visit, and dose level, and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Number of participants by change from baseline in urine leukocyte esterase category
Number of participants in each baseline-to-post-dose category of urine leukocyte esterase at each scheduled laboratory assessment. Categories are the qualitative or semiquantitative results reported by the laboratory. Results are summarized as participant counts by baseline category, post-dose category, scheduled visit, and dose level, and overall.
Measured: Baseline and scheduled post-dose assessments through 24 months after GI001 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start28 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hematology department of the 920th hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862010
- Sponsor's protocol ID
- GI001-01
- Acronym
- GI001-01
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No