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

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

Study Overview

• Status: Recruiting
• Conditions: Leukemia
• Intervention / Treatment: Biological: IM19 CAR-T cells

• Study Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Fei Wu; Phone Number: +8615801390058; Email: wufei@imunopharm.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • First Hospital of China Medical University
      • Contact: Xiaojing Yan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IM19 CAR-T cells	Biological: IM19 CAR-T cells; IM19 CAR-T cells administrated in a dosage to be selected by physician from a specific range.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	Up to 28 days after CAR-T cell infusion
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 Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	Up to 24 weeks after CAR-T cell infusion
Relapse free surviva（PFS）	Up to 24 weeks after CAR-T cell infusion
Duration of Response (DOR)	Up to 24 weeks after CAR-T cell infusion
Overall survival (OS)	Up to 24 weeks after CAR-T cell infusion
Minimal residual disease（MRD）	Up to 24 weeks after CAR-T cell infusion

Collaborators and Investigators

• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Investigators: Principal Investigator: Xiaojing Yan, M.D., Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: CAR-T; B-cell Acute Lymphoblastic Leukemia
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: YMCART1902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No