Clinical trial NCT05309213: 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
Official title: A Phase 1-2 Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Leukemia
Keywords: CAR-T
B-cell Acute Lymphoblastic Leukemia
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 58
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Incidence of Treatment Related adverse events (AEs)
timeFrame: Up to 28 days after CAR-T cell infusion
measure: Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow)
timeFrame: Up to 24 weeks after CAR-T cell infusion
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: At 28 days, 3 months and 6 months after CAR-T cell infusion
measure: Anti-therapeutic IM19 CAR-T cells antibody
timeFrame: Up to 24 weeks after CAR-T cell infusion
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Qian Jiang
role: PRINCIPAL_INVESTIGATOR
References: