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B-Cell Non-Hodgkin LymphomaEarly Phase 1NCT07584850

Evaluation of GI001 for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

A Early Phase 1 study testing GI001 Injection in people with B-Cell Non-Hodgkin Lymphoma, run by Ruijin Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy in adult patients with relapsed or refractory (r/r) CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL) or B-cell Leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Non-Hodgkin Lymphoma
What is being tested?
GI001 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
No sites listed yet
Study dates
20 Apr 2026to 20 Apr 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 years and older (inclusive).
  • Diagnosis: Diagnosis of CD19-positive relapsed/refractory B-cell lymphoma/leukemia:
  • 1) CD19-positive relapsed or refractory B-cell lymphoma/leukemia must meet the following criteria:
  • Histopathological diagnosis includes: indolent lymphoma (iNHL), including but not limited to follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), lymphoplasmacytic lymphoma (LPL), hairy cell leukemia (HCL), etc.; aggressive B-cell lymphoma, including but not limited to diffuse large B-cell lymphoma (DLBCL, including Richter-transformed DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), lymphoblastic lymphoma (LBL), transformed follicular lymphoma (TFL), and T-cell/histiocyte-rich large B-cell lymphoma (TCRBCL), etc., and patients in the lymphoma leukemia phase involving the bone marrow.
  • Definition of refractory: Best response to first-line standard therapy is PD; or response to first-line therapy is SD for 6 months after at least 4 cycles; or no response to second-line or later therapies, including PD as best response to the most recent therapy; or SD for 6 months after at least 2 cycles of the most recent therapy; or disease progression or biopsy-confirmed relapse within 12 months after autologous hematopoietic stem cell transplantation (ASCT); or patients undergoing salvage therapy after ASCT with no remission or relapse (SD or PD) after the last treatment; or relapse more than 3 months after CAR-T cell therapy in CD19+ patients.
  • Definition of relapse: PD again after achieving remission (including PR or CR) following adequate treatment.
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  • Note: Subjects must have been adequately treated and failed or relapsed after guideline-recommended first-line therapy (including anti-CD20 monoclonal antibody combination therapy or BTK inhibitors).
  • 2) B-cell lymphoma/leukemia patients with bone marrow relapse must meet the following criteria:
  • Definition of relapse: Hematological relapse: re-emergence of B-lymphoma cells ( 5%) in peripheral blood or bone marrow in patients who achieved CR, or appearance of extramedullary disease; OR bone marrow or peripheral blood molecular relapse: MRD positivity reappears after HCR and MRD negativity, with an increase of 1 log in MRD levels between two positive samples.
  • Definition of refractory: Failure to achieve CR after at least two cycles of standard chemotherapy; or failure to achieve CR after at least one cycle of treatment following late relapse ( 12 months) after CR; or relapse after HSCT; or patients undergoing salvage therapy after HSCT failing to achieve remission after the last treatment; or Philadelphia chromosome-positive patients who failed to achieve CR or relapsed after at least two types of TKI treatment, or are intolerant/contraindicated to TKI treatment.
  • 3) Patients unsuitable for stem cell transplantation, or with documented refusal of other existing treatments, or for whom no standard treatment plan exists, may also be included.
  • CD19 expression: CD19 positivity detected by IHC or FACS in tumor specimens, bone marrow, or peripheral blood during screening.
  • Measurable disease: B-cell lymphoma subjects must have measurable lesions per Lugano 2014 (LDi > 1.5 cm for nodal, LDi > 1.0 cm for extranodal); B-lymphoma/leukemia subjects must have B-lymphoma cell proportion 5% at screening.
  • ECOG performance status: 0-2.
  • Life expectancy: 12 weeks.
  • Organ function: Adequate organ function meeting the following laboratory results before enrollment:
  • Blood routine: For B-cell lymphoma patients, bone marrow reserve must meet: ANC > 0.5 10E9/L (no short-acting G-CSF within 7 days or long-acting G-CSF within 14 days); ALC 0.5 10E9/L; Platelets 30 10E9/L (no transfusion within 7 days); Hemoglobin 80 g/L (no RBC transfusion within 7 days; EPO allowed). All patients (B-cell lymphoma/leukemia) require absolute CD3+ T-cell count 150/L.
  • Liver function: ALT and AST 3 ULN; Total bilirubin 2 ULN.
  • Renal function: CrCl 60 ml/min (Cockcroft-Gault).
  • Coagulation: Fibrinogen 1.0 g/L; APTT 1.5 ULN; PT 1.5 ULN.
  • Heart: LVEF 55%.
  • Oxygen saturation: > 91%.
  • Steroids: Therapeutic doses of steroids must be stopped 72 hours before GI001 infusion (except physiological replacement doses).
  • CNS prophylaxis: Must be stopped 1 week before GI001 infusion (e.g., intrathecal methotrexate).
  • Contraception: Subjects and spouses agree to use effective contraception from signing ICF until one year after GI001 infusion or until CAR-T cells are not detected in two consecutive PCR tests (whichever is longer).
  • Informed Consent: Voluntarily sign the EC-approved ICF before screening.

Who cannot join

  • Prior antitumor therapy (except drugs proven to enhance or not affect CAR-T efficacy after elution):
  • Cytotoxic chemotherapy within 2 weeks before administration.
  • Small molecule targeted therapy within 2 weeks before administration.
  • Antibody therapy within 3 weeks before administration.
  • PEG-asparaginase within 4 weeks before administration.
  • Immunosuppressive therapy within 4 weeks before administration or requirement for long-term use.
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  • Radiotherapy within 4 weeks before administration.
  • Bendamustine within 6 months before administration.
  • Previous gene therapy products, including CAR-T therapy (except patients with no CAR-T in vivo, normal T-cell count/function, and CD19+ tumor).
  • Previous anti-CD19/anti-CD3 or any other anti-CD19 therapy (except patients with normal T-cell count/function and CD19+ tumor).
  • Other interventional clinical trial drugs or antitumor therapies within 4 weeks or 5 half-lives before administration (whichever is shorter).
  • Other malignancies: Malignancies within 2 years before screening, excluding adequately treated cervical carcinoma in situ, skin cancers, or radically treated localized prostate, breast (DCIS), or papillary thyroid cancers.
  • Organ transplant: History of solid organ transplantation.
  • Immunomodulators: Use within 2 weeks before administration or potential use during the study (e.g., thalidomide, lenalidomide, pomalidomide).
  • Corticosteroids: Requirement for long-term therapeutic doses (Prednisone > 15 mg/day or equivalent), except physiological replacement or topical/inhaled use.
  • CNS involvement: History or presence of CNS infiltration (leukemia/lymphoma cells in CSF; imaging showing masses/enhancement; or neurological symptoms with abnormal CSF).
  • Hypertension: Uncontrolled hypertension despite drug therapy.
  • Cardiac disease: Severe cardiac disease: MI or CABG/stenting within 6 months; unstable angina; NYHA Class III heart failure; severe arrhythmia; severe non-ischemic cardiomyopathy.
  • Systemic disease: Unstable systemic disease: severe liver, kidney, or metabolic disease requiring medication.
  • Infection: Uncontrolled active infection (bacterial, fungal, viral) requiring IV anti-infectives (continuous signs/symptoms without improvement).
  • Neurological/Psychiatric: Stroke or epilepsy within 6 months; other CNS diseases; uncontrolled psychiatric disorders; history deemed to increase risk or interfere with results.
  • Thrombosis: History of DVT or PE within 6 months.
  • Vaccine: Live vaccine within 6 weeks before screening.
  • Surgery: Major surgery within 2 weeks before screening or planned surgery within 2 weeks after administration (except local anesthesia).
  • Pregnancy/Lactation: Pregnant or nursing women, or those planning pregnancy during/after treatment.
  • Toxicity: Prior non-hematological toxicities not resolved to baseline or Grade 2 (except alopecia, fatigue, peripheral neuropathy).
  • Viral pseudotyping: Prior treatment using VSV-G or Nipah virus pseudotyping.
  • Infectious serology: HBsAg+ and/or HBcAb+ with HBV-DNA > detection limit; HCV antibody+ with HCV-RNA > detection limit; HIV antibody+; Syphilis serology+.
  • Extramedullary relapse: B-cell leukemia patients with isolated extramedullary relapse.
  • Allergy: Allergy to the study drug, excipients, or Tocilizumab.
  • Immunodeficiency: Patients with primary immunodeficiency.
  • HSCT: Planned HSCT within 28 days after GI001 injection.
  • Other: Other conditions deemed unsuitable by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Li Wang contact

+86 15214370575

wl_wangdong@126.com

About this study

Official title: An Exploratory Clinical Study to Evaluate the Safety and Efficacy of GI001 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (r/r B-NHL)

The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy in adult patients with relapsed or refractory (r/r) CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL) or B-cell Leukemia. The main questions it aims to answer are:

  • What are the safety and tolerability profiles of GI001, specifically regarding the incidence of Dose-Limiting Toxicities (DLTs) and the determination of the Maximum Tolerated Dose (MTD)?
  • What is the preliminary efficacy of GI001, measured by Objective Response Rate (ORR), Complete Response Rate (CRR), and Duration of Response (DOR)?
  • What are the pharmacokinetic (expansion and persistence of CAR-T cells) and pharmacodynamic (cytokine changes) characteristics of GI001?
Read more

Participants will:

  • Undergo a screening process (D-30 to D-3) and baseline evaluation to ensure eligibility, including confirmation of CD19-positive disease.
  • Receive a single intravenous infusion of GI001 at one of four designated dose levels (1E8, 3E8, 7E8 or 1E9 TU) following an "Accelerated Titration" and "3+3" dose-escalation design.
  • Remain hospitalized for at least 14 days post-infusion for intensive safety monitoring, specifically for Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
  • Provide multiple blood, saliva, and urine samples for pharmacokinetic (PK), pharmacodynamic (PD), and exploratory analysis (including immunogenicity and viral shedding).
  • Participate in efficacy and safety follow-ups through Month 24, followed by a long-term safety follow-up for up to 15 years.
Read the detailed description

Study Design and Methodology This is an investigator-initiated, open-label, single-arm, dose-escalation, and expansion exploratory clinical study. The study utilizes an "Accelerated Titration" combined with a standard "3+3" design to evaluate the safety, tolerability, and preliminary anti-tumor activity of GI001 injection-an innovative in vivo CAR-T therapy-in patients with relapsed or refractory (r/r) CD19+ B-cell malignancies.

Dose Escalation Phase Four dose levels have been pre-specified: 1E8, 3E8, 7E8 or 1E9 TU

  1. Accelerated Titration: The first subject will be enrolled at the starting dose ( TU). If no Dose-Limiting Toxicity (DLT) or Grade 2 treatment-related adverse events occur within the 28-day DLT observation period, the study may proceed to the next dose level with a single subject.
  2. Standard 3+3 Design: If a DLT or significant toxicity (as defined in the protocol) is observed during the accelerated phase, the study will transition to a traditional 3+3 escalation model to ensure subject safety and more robustly determine the Maximum Tolerated Dose (MTD).

Dose Expansion Phase Upon completion of the escalation phase and determination of the MTD or Recommended Dose for Expansion (RDE), an additional 12-18 subjects will be enrolled to further characterize the safety profile and provide a more comprehensive assessment of preliminary efficacy.

Treatment and Monitoring Subjects will receive a single intravenous infusion of GI001. Due to the risk of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), subjects must be hospitalized for intensive monitoring for at least 14 days post-infusion. Clinical assessments, including physical examinations, vital signs, and laboratory tests (hematology, biochemistry, and coagulation), will be conducted at frequent intervals.

Pharmacokinetics (PK) and Pharmacodynamics (PD)

A central laboratory will analyze peripheral blood, saliva, and urine samples to:

  • Quantify the expansion and persistence of GI001 CAR-T cells using qPCR and/or Flow Cytometry.
  • Monitor systemic cytokine levels (e.g., IL-6, IFN-, TNF-) to correlate with safety and efficacy outcomes.
  • Assess immunogenicity (Anti-Drug Antibodies) and potential viral shedding (RCL testing) to ensure long-term biological safety.

Long-Term Follow-up Following the initial 24-month efficacy and safety evaluation period, subjects will be invited to participate in a long-term safety follow-up study for up to 15 years, in accordance with regulatory guidelines for gene therapy products, to monitor for delayed adverse events such as secondary malignancies or prolonged B-cell aplasia.

Being tested
GI001 Injection
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GI001 InjectionBiological

    Biological: GI001 Injection GI001 is an innovative chimeric antigen receptor T-cell (CAR-T) therapy targeting CD19-positive B-cell malignancies.

    Administration: Subjects will receive a single dose of GI001 via intravenous (IV) infusion on Day 0.

    Dosing Logic: The study follows a dose-escalation design with four pre-specified dose levels: 1E8, 3E8, 7E8, and 1E9 Transducing Units (TU). The dosage is determined based on the total TU count as measured by flow cytometry.

    Pre-medication: Prior to infusion, subjects may receive pre-conditioning (lymphodepletion chemotherapy) as per protocol and prophylactic medication (e.g., promethazine or diphenhydramine) to prevent infusion reactions.

Study groups in NCT07584850
Study groupRoleWhat they receive
GI001 Experimental GroupExperimentalPatients with relapsed or refractory CD19-positive B-cell malignancies receiving a single intravenous infusion of GI001. The study includes a dose-escalation phase ( 1E8 to 1E9 TU) and a subsequent expansion phase at the recommended dose.
Receives: Biological: GI001 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    • Title: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    • Description: Adverse events will be assessed and graded according to NCI CTCAE v6.0 for general toxicities. Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) will be graded according to ASTCT 2019 criteria. This measure reports the number of participants experiencing these events.

    Measured: Baseline up to 24 months post-infusion

  2. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    DLTs are defined as specific severe toxicities occurring within the DLT observation period. This measure is used to evaluate safety, determine the Maximum Tolerated Dose (MTD), and identify the Recommended Dose for Expansion (RDE).

    Measured: D0 up to D28

  3. Number of Participants with Clinically Significant Changes in Vital Signs

    This measure reports the number of participants experiencing clinically significant abnormal changes from baseline in vital signs, including systolic/diastolic blood pressure, heart rate, respiratory rate, or body temperature.

    Measured: Baseline up to 24 months post-infusion

  4. Number of Participants with Clinical Laboratory Abnormalities

    This measure reports the number of participants experiencing clinically significant laboratory abnormalities or Grade 3/4 toxicities (assessed via hematology, serum chemistry, coagulation, and urinalysis) from baseline.

    Measured: Baseline up to 24 months post-infusion

  5. Number of Participants with Clinically Significant Abnormal Physical Examination Findings

    The number of participants who develop new, clinically significant abnormal findings during physical examinations compared to baseline.

    Measured: Baseline up to 24 months post-infusion

  6. Changes in 12-Lead Electrocardiogram (ECG) Parameters from Baseline

    Includes changes in heart rate, PR interval, QRS duration, and QTcF interval from baseline to assess cardiac safety.

    Measured: Baseline up to 24 months post-infusion

  7. Changes in Eastern Cooperative Oncology Group (ECOG) Performance Status Score from Baseline

    The ECOG performance status scale ranges from 0 (fully active) to 5 (dead). Higher scores indicate worse performance status. The change in score from baseline will be reported.

    Measured: Baseline up to 24 months post-infusion

Secondary outcomes (14)

  1. Objective Response Rate (ORR)

    The proportion of participants achieving a Complete Response (CR) or Partial Response (PR). For B-NHL, tumor response is assessed per Lugano 2014 criteria; for B-ALL, response is defined according to protocol-specified clinical criteria.

    Measured: D0 up to 24 months post-infusion

  2. Complete Response Rate (CRR)

    The proportion of participants achieving a Complete Response (CR) as their best overall response.

    Measured: D0 up to 24 months post-infusion

  3. Duration of Response (DOR) in Months

    Defined as the time from the first documented disease response (CR or PR) to the date of first documented disease progression or death from any cause.Reported in months.

    Measured: D0 up to 24 months post-infusion

  4. Progression-Free Survival (PFS)

    Defined as the time from the date of first study drug infusion to the date of first documented disease progression or death from any cause.

    Measured: D0 up to 24 months post-infusion

  5. Overall Survival (OS)

    Defined as the time from the date of first study drug infusion to the date of death from any cause.

    Measured: D0 up to 24 months post-infusion

  6. Minimal Residual Disease (MRD) Negativity Rate

    The proportion of participants achieving MRD negativity as determined by highly sensitive detection methods (applicable primarily for B-ALL participants).

    Measured: D0 up to 24 months post-infusion

  7. Peak Concentration (Cmax) of CAR-T Cells and CAR Copies

    The maximum observed concentration of CD19 CAR-T cells and CAR copy numbers in peripheral blood following GI001 infusion.

    Measured: Baseline, and multiple time points up to Day 28"

  8. Time to Peak Concentration (Tmax) of CAR-T Cells

    The time required to reach the maximum observed concentration (Cmax) of CD19 CAR-T cells and CAR copy numbers in peripheral blood following GI001 infusion.

    Measured: Baseline, and multiple time points up to Day 28"

  9. Area Under the Curve from Day 0 to Day 28 (AUC 0-28d)

    The area under the concentration-time curve from the time of GI001 infusion (Day 0) to Day 28 for CD19 CAR-T cells and CAR copy numbers in peripheral blood.

    Measured: Baseline, and multiple time points up to Day 28"

  10. Changes in Serum Cytokine Concentrations from Baseline

    ncludes changes in levels of systemic inflammatory markers such as IL-2, IL-6, IL-10, IFN-γ, and TNF-α from baseline to evaluate the pharmacodynamic activity and biological impact of the CAR-T treatment.

    Measured: Baseline, and multiple time points through 6 months post-infusion

  11. Changes in Serum C-Reactive Protein (CRP) Levels from Baseline

    Measurement of changes in serum CRP levels from baseline to monitor systemic inflammatory response.

    Measured: Baseline, and multiple time points through 6 months post-infusion

  12. Changes in Serum Ferritin Levels from Baseline

    Measurement of changes in serum ferritin levels from baseline to monitor systemic inflammatory response.

    Measured: Baseline, and multiple time points through 6 months post-infusion

  13. Changes in Peripheral Blood Lymphocyte Subset Counts from Baseline

    Includes changes in the absolute cell counts of CD19+ B cells, CD3+ T cells, CD4+ T cells, and CD8+ T cells from baseline to evaluate immune cell profiles.

    Measured: Baseline, and multiple time points through 6 months post-infusion

  14. Changes in CD4/CD8 T-Cell Ratio from Baseline

    Measurement of changes in the ratio of CD4+ T cells to CD8+ T cells in peripheral blood from baseline.

    Measured: Baseline, and multiple time points through 6 months post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start20 Apr 2026 (estimated)
  3. Primary completion20 Jul 2026 (estimated)
  4. Study completion20 Apr 2029 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07584850
Sponsor's protocol ID
GI001-02
Status last verified
May 2026
First submitted
19 Apr 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GI001 Injection in people with B-Cell Non-Hodgkin Lymphoma, run by Ruijin Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Li Wang (+86 15214370575, wl_wangdong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 24 months post-infusion). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07584850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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