Leukemia
Conditions
Keywords
CAR-T, B-cell Acute Lymphoblastic Leukemia
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.
Interventions
BIOLOGICALIM19 CAR-T cells
IM19 CAR-T cells administrated in a dosage to be selected by physician from a specific range.
Sponsors
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Duration of Response (DOR) | Up to 24 weeks after CAR-T cell infusion |
| Objective response rate (ORR) | Up to 24 weeks after CAR-T cell infusion |
| Minimal residual disease（MRD） | Up to 24 weeks after CAR-T cell infusion |
| Overall survival (OS) | Up to 24 weeks after CAR-T cell infusion |
| Relapse free surviva（PFS） | Up to 24 weeks after CAR-T cell infusion |
Countries
China
Contacts
Primary ContactFei Wu
Outcome results
None listed