Status:
UNKNOWN
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
Lead Sponsor:
Beijing Immunochina Medical Science & Technology Co., Ltd.
Conditions:
Leukemia
Eligibility:
All Genders
3-25 years
Phase:
PHASE1
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05309213
Start Date
April 1 2022
End Date
June 1 2025
Last Update
April 4 2022
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