B Cell MalignanciesEarly Phase 1NCT06375161
Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.
A Early Phase 1 study testing anti-CD19-CAR-T cells in people with B Cell Malignancies, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial summary
This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment. In this study phase, a traditional "3+3" trial design is employed for dose escalation. Read more about this study
- Who is it for?
- Ages 18 to 70 weeks
- Conditions the study is for
- B Cell Malignancies
- What is being tested?
- anti-CD19-CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2023to 10 Dec 2039
- 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 to 70 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Voluntary participation in the clinical trial; the individual or legal guardian fully understands and consents to the study by signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.
- Age between 18-70 years.
- Patients who are refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and not suitable for other treatment options such as a second hematopoietic stem cell transplantation.
- Relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) is defined as one of the following:
- Primary refractory disease
- First relapse if the first remission was ≤12 months
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- Relapse or refractory disease after two or more lines of systemic therapy
- Relapse or refractory disease after allogeneic transplantation, provided that at least 100 days have elapsed since transplantation at the time of enrollment, and no immunosuppressive drugs have been used for at least 4 weeks prior to enrollment, except for low-dose steroids (≤5 mg prednisone or equivalent).
- Subjects with Ph+ B-cell ALL who are intolerant or ineligible for treatment with tyrosine kinase inhibitors (TKIs), or have relapsed/refractory disease after receiving at least two different TKI treatments, are eligible.
- Relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) is defined as one of the following:
- No response to first-line treatment (primary refractory disease); excluding subjects intolerant to first-line chemotherapy - PD as the best response to first-line treatment - Best response after at least 4 cycles of first-line treatment (such as 4 cycles of RCHOP) is SD, and the duration of SD after the last dose does not exceed 6 months.
- No response to second-line or subsequent treatments - PD as the best response to the most recent treatment regimen - Best response after at least 2 cycles of last-line treatment is SD, and the duration of SD after the last dose does not exceed 6 months.
- Refractory after ASCT
- Disease progression or relapse ≤12 months post-ASCT (relapse must be confirmed by biopsy).
- If salvage therapy is given post-ASCT, subjects must have had no response or relapse after the last-line treatment.
- Bone marrow smear reports showing tumor cells ≥5% in ALL patients.
- Patients with refractory or relapsed NHL meet one of the following subtypes:
- 1) DLBCL-NOS. 2) Primary mediastinal large B-cell lymphoma (PMBCL). 3) Transformed follicular lymphoma (TFL), previously treated with follicular lymphoma chemotherapy, subsequently transformed into refractory disease after DLBCL.
- 4) Mantle cell lymphoma. 5) High-grade B-cell lymphoma. 6) CLL/SLL.
- ECOG performance status ≤2.
- Estimated life expectancy of at least 12 weeks.
- Adequate venous access (for single collection) and no other contraindications to blood cell separation.
- Laboratory test results at screening must meet the following requirements, and subjects must not have received colony-stimulating factors (G-CSF/PEG-CSF) within 2 weeks prior to hematological assessment (except for low-dose steroids):
- 1) Absolute neutrophil count ≥1.0×10^9/L, ALL eligibility to be determined by the investigator.
- 2) Hemoglobin ≥60 g/L (without red blood cell transfusion within 14 days). 3) Platelets ≥50×10^9/L, ALL eligibility to be determined by the investigator. 4) Absolute lymphocyte count (ALC) ≥ 0.5×10^9/L; if insufficient, and T-cell proportion is high in the lymphocyte subset, the investigator can discuss with the sponsor.
- 5) Serum total bilirubin ≤1.5× upper limit of normal (ULN). 6) Aspartate transaminase (AST), alanine transaminase (ALT) ≤2.5× ULN. 7) Creatinine <1.5× ULN and creatinine clearance ≥60 mL/minute.
- Left ventricular ejection fraction ≥45%, echocardiography (ECHO) confirms no clinically significant pericardial effusion (except for trace or physiological), and electrocardiography results have no clinical significance.
- Baseline oxygen saturation in room air >92%.
- Women of childbearing potential must have negative serum or urine pregnancy tests (women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered women of childbearing potential).
Who cannot join
- ALL with central nervous system abnormalities, excluding clinically evident neurological changes CNS-2 and CNS-3.
- 1) CNS-3 disease, defined as detectable tumor cells in the cerebrospinal fluid (CSF), with ≥5 WBCs per mm3, with or without neurological changes.
- 2) CNS-2 disease, defined as detectable tumor cells in the CSF, with <5 WBCs per mm3, and neurological changes.
- Note: Subjects with CNS-1 (no tumor cells detected in CSF) and CNS-2 with no clinically evident neurological changes are eligible for this study.
- Evidence of central nervous system lymphoma on brain MRI; active primary central nervous system DLBCL, unless the central nervous system involvement has been effectively treated (i.e., participants are asymptomatic), and >4 weeks have elapsed since local treatment before enrollment.
- Active central nervous system diseases such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the central nervous system.
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- History of or concurrent malignancies other than CD19+ malignancies.
- Clinically significant cardiac diseases, or arrhythmias not controlled by medication.
- Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections, or requiring intravenous antibiotic therapy; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed if responsive to treatment and after consultation with the sponsor's medical monitor.
- Hepatitis B (positive for hepatitis B surface antigen and/or positive for hepatitis B core antibody with hepatitis B DNA >1000 copies/ml) and hepatitis C (positive for hepatitis C antibody); syphilis, human immunodeficiency virus (HIV) infection.
- Presence of any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, indwelling Foley catheter, bile drainage tube, or pleural/peritoneal/pericardial catheter); use of dedicated central venous access devices such as Port-A-Cath® or Hickman® catheters is allowed.
- Prior medication:
- CD19-targeted therapy.
- Use of chlorambucil or cladribine within 3 months prior to enrollment, or use of PEG-asparaginase within 3 weeks prior to enrollment.
- Injection of live vaccines within 4 weeks prior to enrollment.
- Donor lymphocyte infusion (DLI) within 28 days prior to enrollment.
- Any drugs used for GVHD treatment within 4 weeks prior to enrollment (such as calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, or salidroside), or use of immunosuppressive antibodies (such as anti-CD20, anti-tumor necrosis factor, anti-interleukin-6, or anti-interleukin-6 receptor) within 4 weeks prior to enrollment.
- Immunostimulatory or immunosuppressive therapy within 4 weeks prior to enrollment (such as interferon-alpha, interferon-beta, IL-2, enoxaparin, efalizumab, alemtuzumab, tacrolimus, or mycophenolate).
- Any systemic inhibitory/stimulatory immune checkpoint molecule therapy within 4 weeks prior to enrollment (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc.).
- Use of systemic cytotoxic drugs within 2 weeks prior to enrollment, including daily or weekly low-dose maintenance chemotherapy (such as cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or mephalan, vincristine, etc.).
- Long-acting growth factors within 14 days prior to single collection (such as pegfilgrastim) or short-acting growth factors within 5 days prior to single collection or drugs used for cell mobilization (such as G-CSF/PEG-CSF, plerixafor).
- Receipt of radiotherapy within 2 weeks prior to enrollment.
- Must avoid pharmacological doses of corticosteroids (>5 mg/day of prednisone or equivalent) and other immunosuppressive drugs within 7 days prior to single collection.
- Use of venetoclax (BCL-2 inhibitor) within 4 days prior to single collection.
- Short-acting targeted therapies (such as tyrosine kinase inhibitors) within 72 hours prior to single collection.
- Use of idelalisib (oral PI3Kδ inhibitor) within 2 days prior to single collection.
- Use of lenalidomide within 1 day prior to single collection.
- Active graft-versus-host disease (GVHD) using CIBMTR acute GVHD grading system ≥ grade 2 or requiring systemic steroids greater than physiological doses.
- History of autoimmune diseases in the past 2 years (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) resulting in end-organ damage or requiring systemic immunos uppressive/disease-modifying therapy.
- History of myocardial infarction, cardiac vascular surgery or stent implantation, unstable angina, or other clinically significant cardiac diseases within 12 months prior to enrollment.
- History of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Costello syndrome, Shwachman-Diamond syndrome, etc.
- Symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within the past 6 months. Subjects need to be on prophylactic anticoagulation.
- Past or present concurrent malignancies (excluding skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignancies that have not been treated and effectively controlled in the past five years).
- Use of other investigational medicinal products within 30 days prior to screening.
- Pregnant or lactating women of childbearing age, due to potential risks of chemotherapy to the fetus or infant. Women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered of childbearing potential.
- Subjects unwilling to practice contraception from the agreement to treatment completion of conditional chemotherapy or CAR T infusion within 12 months (whichever is longer).
- Any medical conditions that may interfere with the safety or efficacy assessment of the study treatment.
- Subjects unlikely, in the investigator's judgment, to complete all protocol-required study visits or procedures, including follow-up, or comply with study requirements.
- Previous use of any CAR-T cell products or other genetically modified T cell therapies.
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
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200333
Aibin Liang, +8618601670600, lab7182@tongji.edu.cn
Ping LI, +86 135 6418 1131, lilyforever@126.com
About this study
Official title: An Exploratory Clinical Study Evaluating the Safety and Efficacy of Infusion of Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.
This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment.
In this study phase, a traditional "3+3" trial design is employed for dose escalation.
Read the detailed description
The study plans to include CD19-positive relapsed/refractory B-cell tumor patients. After the screening period, peripheral blood mononuclear cell (PBMC) collection, and lymphocyte depletion pre-treatment period, subjects will receive a single infusion of anti-CD19-CAR-T cells. In addition to the baseline period, efficacy assessments will be conducted monthly for ALL subjects and at weeks 4, 12, 24, 36, and 48 post-treatment for NHL subjects, until disease progression (PD), relapse, change of treatment regimen, death, intolerable toxicity, at the discretion of the investigator, or voluntary withdrawal by the patient (whichever occurs first).
Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Safety of anti-CD19-CAR-T cell therapy will be evaluated through laboratory tests, 12-lead electrocardiograms, vital signs, physical examinations, etc. Blood samples will be collected from subjects to assess cellular pharmacokinetics and explore the effects of cellular drugs on ferritin, C-reactive protein, and related cytokines.
- Conditions
- B Cell Malignancies
- Being tested
- anti-CD19-CAR-T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19-CAR-T cellsBiological
Before cell infusion, Investigator may decide, based on necessity, whether to administer prophylactic medication, which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others.
Subjects are allowed to receive adequate supportive care after anti-CD19-CAR-T cell infusion, including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesics, etc.
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19-CAR-T Cells | Experimental | anti-CD19-CAR-T cell infusion. Infusion doses: The planned infusion doses are as follows: the first dose group at 1×10^5 cells/kg; the second dose group at 3×10^5 cells/kg; the third dose group at 1×10^6 cells/kg. Infusion doses refer to the number of CAR-positive cells.
Administration route: anti-CD19-CAR-T cells are administered via intravenous drip at a rate of approximately 2 to 5 mL/minute using an infusion pump, with a recommended infusion time of less than 30 minutes. Receives: Biological: anti-CD19-CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity
The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities (DLTs). Safety evaluations are performed in accordance with the NCI-CTCAE version 5.0 standards (Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria).
Measured: Up to 28 days from CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start11 Dec 2023
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell MalignanciesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aibin Liang，MD，Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Aibin Liang, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375161
- Sponsor's protocol ID
- CD19-CN-A6
- Status last verified
- Aug 2023
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study Evaluating the Safety and Efficacy of Infusion of Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.
- ClinicalTrials.gov ID
- NCT06375161
- Acronym / sponsor ID
- CD19-CN-A6
- Conditions
- B Cell Malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Dec 2039 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment.
In this study phase, a traditional "3+3" trial design is employed for dose escalation.
Detailed description
The study plans to include CD19-positive relapsed/refractory B-cell tumor patients. After the screening period, peripheral blood mononuclear cell (PBMC) collection, and lymphocyte depletion pre-treatment period, subjects will receive a single infusion of anti-CD19-CAR-T cells. In addition to the baseline period, efficacy assessments will be conducted monthly for ALL subjects and at weeks 4, 12, 24, 36, and 48 post-treatment for NHL subjects, until disease progression (PD), relapse, change of treatment regimen, death, intolerable toxicity, at the discretion of the investigator, or voluntary withdrawal by the patient (whichever occurs first).
Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Safety of anti-CD19-CAR-T cell therapy will be evaluated through laboratory tests, 12-lead electrocardiograms, vital signs, physical examinations, etc. Blood samples will be collected from subjects to assess cellular pharmacokinetics and explore the effects of cellular drugs on ferritin, C-reactive protein, and related cytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD19-CAR-T Cells | Experimental | Biological: anti-CD19-CAR-T cellsanti-CD19-CAR-T cell infusion. Infusion doses: The planned infusion doses are as follows: the first dose group at 1×10^5 cells/kg; the second dose group at 3×10^5 cells/kg; the third dose group at 1×10^6 cells/kg. Infusion doses refer to the number of CAR-positive cells. Administration route: anti-CD19-CAR-T cells are administered via intravenous drip at a rate of approximately 2 to 5 mL/minute using an infusion pump, with a recommended infusion time of less than 30 minutes. |
Who may qualify
- Ages
- 18 to 70 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (29 listed)
- Voluntary participation in the clinical trial; the individual or legal guardian fully understands and consents to the study by signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.
- Age between 18-70 years.
- Patients who are refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and not suitable for other treatment options such as a second hematopoietic stem cell transplantation.
- Bone marrow smear reports showing tumor cells ≥5% in ALL patients.
- Patients with refractory or relapsed NHL meet one of the following subtypes:
Key exclusion criteria (39 listed)
- ALL with central nervous system abnormalities, excluding clinically evident neurological changes CNS-2 and CNS-3.
- 1) CNS-3 disease, defined as detectable tumor cells in the cerebrospinal fluid (CSF), with ≥5 WBCs per mm3, with or without neurological changes.
- 2) CNS-2 disease, defined as detectable tumor cells in the CSF, with <5 WBCs per mm3, and neurological changes.
- Note: Subjects with CNS-1 (no tumor cells detected in CSF) and CNS-2 with no clinically evident neurological changes are eligible for this study.
- Evidence of central nervous system lymphoma on brain MRI; active primary central nervous system DLBCL, unless the central nervous system involvement has been effectively treated (i.e., participants are asymptomatic), and >4 weeks have elapsed since local treatment before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-CD19-CAR-T cellsBefore cell infusion, Investigator may decide, based on necessity, whether to administer prophylactic medication, which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others. Subjects are allowed to receive adequate supportive care after anti-CD19-CAR-T cell infusion, including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesics, etc. | Biological | anti-CD19-CAR-T Cells |
Primary outcome
Incidence of dose-limiting toxicity
Time frame: Up to 28 days from CAR-T infusion
The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities (DLTs). Safety evaluations are performed in accordance with the NCI-CTCAE version 5.0 standards (Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aibin Liang principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-CD19-CAR-T cells in people with B Cell Malignancies, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
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 29 inclusion and 39 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: looking for participants now, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Aibin Liang (+86 21 6611 1019, lab7182@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (time frame: Up to 28 days from CAR-T infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.