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

NCT ID: NCT05309213

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-06-01

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

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IM19 CAR-T cells

Group Type: EXPERIMENTAL

IM19 CAR-T cells

Intervention Type: BIOLOGICAL

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

Interventions

IM19 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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Immunochina Medical Science & Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qian Jiang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

Fei Wu, MD

Role: CONTACT

wufei@immunochina.com

+8615801390058

Other Identifiers

SD3

Identifier Type: -

Identifier Source: org_study_id