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

Enrolling

Early Phase 1

Conditions

Leukemia

Treatments

Biological: IM19 CAR-T cells

Study type

Interventional

Funder types

Industry

Identifiers

YMCART1902

Details and patient eligibility

About

This is a open-label to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia.

Enrollment

9 estimated patients

Sex

All

Ages

3 to 70 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 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.