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

NCT05480501 | Unknown Early Phase 1

• 1 other identifier: YMCART1902
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

CAR-T; B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

IM19 CAR-T cells

EXPERIMENTAL

Biological: IM19 CAR-T cells

Interventions

IM19 CAR-T cells BIOLOGICAL

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

IM19 CAR-T cells

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

Study Sites (1)

First Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Leukemia; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Xiaojing Yan, M.D.

  Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu

CONTACT

+8615801390058; wufei@imunopharm.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: July 11, 2022
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

CN (1)