Leukemia
Conditions
Keywords
CAR-T, B-cell Acute Lymphoblastic Leukemia
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
Interventions
BIOLOGICALIM19 CAR-T cells
IM19 CAR-T cells will be administered at dose level:5 x 10\^4 CAR+ T cells/kg,1x 10\^5 CAR+ T cells/kg,3 x 10\^5 CAR+ T cells/kg,1 x 10\^6 CAR+ T cells/kg
Sponsors
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 25 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Related 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 | The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactFei Wu, MD
Outcome results
None listed