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

Beijing Immunochina Medical Science & Technology

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Leukemia

Treatments

Biological: IM19 CAR-T cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT05309213

SD3

Details and patient eligibility

About

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

Enrollment

58 estimated patients

Sex

All

Ages

3 to 25 years old

Volunteers

No Healthy Volunteers

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 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.