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

Conditions: Leukemia

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 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.

Keywords: car-t b-cell acute lymphoblastic leukemia