Clinical trial NCT05480501: 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: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Leukemia
Keywords: CAR-T
B-cell Acute Lymphoblastic Leukemia
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 9
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a open-label 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 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.

Primary outcomes:
measure: Incidence of 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: Up to 24 weeks after CAR-T cell infusion
measure: Relapse free surviva（PFS）
timeFrame: Up to 24 weeks after CAR-T cell infusion
measure: Duration of Response (DOR)
timeFrame: Up to 24 weeks after CAR-T cell infusion
measure: Overall survival (OS)
timeFrame: Up to 24 weeks after CAR-T cell infusion
measure: Minimal residual disease（MRD）
timeFrame: Up to 24 weeks after CAR-T cell infusion
Other outcomes:
Locations:
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Hospital of China Medical University
name: Xiaojing Yan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: