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
Early Phase 1
Recruiting
- Conditions
- Leukemia
- Interventions
- Biological: IM19 CAR-T cells
- Registration Number
- NCT05480501
- Lead Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- 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.
- 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.
- Morphological evidence of disease in bone marrow (at least 5% blasts).
- Aged 3 to 70 years.
- Estimated life expectancy >3 months.
- ECOG performance status of 0 or 1(age ≥ 16 years) or Lansky (age < 16 years).
- 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.
- Adequate organ function.
- Volunteer to participate in this trial and sign on the informed consent.
Exclusion Criteria
- Subjects with lsolated extramedullary disease relapse.
- Subjects with Burkitt's lymphoma.
- Subjects has obvious symptoms of central nervous system invasion and needs targeted treatment.
- Subjects has previously received gene product therapy.
- 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.
- Subjects has received chemotherapy or radiotherapy within 3 days before leukapheresis.
- Subjects received systemic steroids within 5 days prior to leukapheresis.
- Subjects received drugs that stimulated the production of hematopoietic cells in the bone marrow for 5 days prior to leucapheresis.
- Subjects has participated in other clinical studies within 1 month before screening or plan to participate in other drug clinical trials during this study.
- Subjects received allogeneic cell therapy within 6 weeks before leukapheresis.
- Subjects with History or presence of CNS disorder.
- Subjects with HBV, HCV, HIV ,EBV,ECV or syphilis infection at the time of screening.
- 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.
- Subjects with other tumors in the past 5 years.
- Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IM19 CAR-T cells IM19 CAR-T cells -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China