Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia
Study Details
Study Description
Brief Summary
This is a open-label to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IM19 CAR-T cells
|
Biological: IM19 CAR-T cells
IM19 CAR-T cells administrated in a dosage to be selected by physician from a specific range.
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events (AEs) [Up to 28 days after CAR-T cell infusion]
- Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow ) [Up to 24 weeks after CAR-T cell infusion]
Secondary Outcome Measures
- Objective response rate (ORR) [Up to 24 weeks after CAR-T cell infusion]
- Relapse free surviva（PFS） [Up to 24 weeks after CAR-T cell infusion]
- Duration of Response (DOR) [Up to 24 weeks after CAR-T cell infusion]
- Overall survival (OS) [Up to 24 weeks after CAR-T cell infusion]
- Minimal residual disease（MRD） [Up to 24 weeks after CAR-T cell infusion]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Relapsed or refractory B-ALL, defined as：1）Not chieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia. 2）Any relapse after HSCT and must be ≥ 6 months from HSCT at the time of IM19 CAR-T cells infusion. 3）Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen.
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Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI ± chemotherapy ；Ph + all patients with T315I mutation are not required to receive at least two TKI ± chemotherapy in the absence of effective TKI therapy.
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Morphological evidence of disease in bone marrow (at least 5% blasts).
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Aged 3 to 70 years.
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Estimated life expectancy >3 months.
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ECOG performance status of 0 or 1(age ≥ 16 years) or Lansky (age < 16 years).
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Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up.
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Adequate organ function.
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Volunteer to participate in this trial and sign on the informed consent.
Exclusion Criteria:
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Subjects with lsolated extramedullary disease relapse.
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Subjects with Burkitt's lymphoma.
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Subjects has obvious symptoms of central nervous system invasion and needs targeted treatment.
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Subjects has previously received gene product therapy.
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Subjects has graft-versus-host response（GVHD） and need to use immunosuppressants or GVHD ≥ grade 2 or being treated with anti GVHD or suffering from autoimmune diseases.
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Subjects has received chemotherapy or radiotherapy within 3 days before leukapheresis.
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Subjects received systemic steroids within 5 days prior to leukapheresis.
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Subjects received drugs that stimulated the production of hematopoietic cells in the bone marrow for 5 days prior to leucapheresis.
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Subjects has participated in other clinical studies within 1 month before screening or plan to participate in other drug clinical trials during this study.
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Subjects received allogeneic cell therapy within 6 weeks before leukapheresis.
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Subjects with History or presence of CNS disorder.
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Subjects with HBV, HCV, HIV ,EBV,ECV or syphilis infection at the time of screening.
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Pregnant or lactating, or planning pregnancy within 180 days after the end of CAR-T cells infusion, or male patients whose partners plan pregnancy 180 days after their CAR-T cell infusion.
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Subjects with other tumors in the past 5 years.
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Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Hospital of China Medical University | Shenyang | Liaoning | China |
Sponsors and Collaborators
- Beijing Immunochina Medical Science & Technology Co., Ltd.
Investigators
- Principal Investigator: Xiaojing Yan, M.D., Hospital of China Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YMCART1902