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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

B

Beijing Immunochina Medical Science & Technology

Status and phase

Enrolling
Early Phase 1

Conditions

Leukemia

Treatments

Biological: IM19 CAR-T cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT05480501
YMCART1902

Details and patient eligibility

About

This is a open-label to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia.

Enrollment

9 estimated patients

Sex

All

Ages

3 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

IM19 CAR-T cells
Experimental group
Treatment:
Biological: IM19 CAR-T cells

Trial contacts and locations

1

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Central trial contact

Fei Wu

Data sourced from clinicaltrials.gov

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