NCT05309213Not yet recruitingPhase 1
A Phase 1-2 Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia
Beijing Immunochina Medical Science & Technology Co., Ltd.0 sites58 target enrollmentStarted: April 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 58
- Primary Endpoint
- Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow)
Study Overview
Brief Summary
This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Relapsed or refractory B-ALL, defined as:
- •Not chieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia.
- •Any relapse after HSCT and must be ≥ 6 months from HSCT at the time of IM19 CAR-T cells infusion.
- •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 25 years, either sex;
- •Estimated life expectancy >3 months;
- •ECOG performance status of 0 or 1(age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50;
- •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
- •Isolated extramedullary disease relapse；
- •Burkitt's lymphoma；
- •Patient has obvious symptoms of central nervous system invasion and needs targeted treatment;
- •Patient has previously received gene product therapy;
- •Patients have 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;
- •Patient received chemotherapy or radiotherapy within 3 days before leukapheresis
- •Patient used systemic steroids within 5 days before leucapheresis, except those who were recently or currently using inhaled steroids;
- •Patients who used drugs to stimulate the production of bone marrow hematopoietic cells within 5 days before leucapheresis;
- •Patients have participated in other clinical studies within 1 month before screening or plan to participate in other drug clinical trials during this study;
- •Patient received allogeneic cell therapy within 6 weeks before CAR-T cell infusion, such as donor lymphocyte infusion(DLI)；
- •History or presence of CNS disorder, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia / hemorrhage / cerebral infarction), brain edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome or mental disease;
- •Patients has 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;
- •Patients with other tumors in the past 5 years;
- •Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment.
Outcomes
Primary Outcomes
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow)
Time Frame: Up to 24 weeks after CAR-T cell infusion
The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.
Incidence of Treatment Related adverse events (AEs)
Time Frame: Up to 28 days after CAR-T cell infusion
Secondary Outcomes
- Objective response rate (ORR)(At 28 days, 3 months and 6 months after CAR-T cell infusion)
- Anti-therapeutic IM19 CAR-T cells antibody(Up to 24 weeks after CAR-T cell infusion)
Investigators
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