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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480501
• Other study ID #: YMCART1902
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 11, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2022
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: Fei Wu
• Phone: +8615801390058
• Email: wufei[@]imunopharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: October 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• IM19 CAR-T cells
IM19 CAR-T cells administrated in a dosage to be selected by physician from a specific range.

Locations

Country	Name	City	State
China	First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		Up to 28 days after CAR-T cell infusion
Primary	Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow )		Up to 24 weeks after CAR-T cell infusion
Secondary	Objective response rate (ORR)		Up to 24 weeks after CAR-T cell infusion
Secondary	Relapse free surviva(PFS)		Up to 24 weeks after CAR-T cell infusion
Secondary	Duration of Response (DOR)		Up to 24 weeks after CAR-T cell infusion
Secondary	Overall survival (OS)		Up to 24 weeks after CAR-T cell infusion
Secondary	Minimal residual disease(MRD)		Up to 24 weeks after CAR-T cell infusion