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

NCT05309213 | Unknown Phase 1

• 1 other identifier: SD3
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I/II, open-label, multicenter study 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 Treatment Related 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)

  The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.

  Up to 24 weeks after CAR-T cell infusion

Secondary Outcomes (2)

• Objective response rate (ORR)

  At 28 days, 3 months and 6 months after CAR-T cell infusion

• Anti-therapeutic IM19 CAR-T cells antibody

  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 will be administered at dose level:5 x 10\^4 CAR+ T cells/kg,1x 10\^5 CAR+ T cells/kg,3 x 10\^5 CAR+ T cells/kg,1 x 10\^6 CAR+ T cells/kg

IM19 CAR-T cells

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Relapsed or refractory B-ALL, defined as:
• Not chieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia.
• Any relapse after HSCT and must be ≥ 6 months from HSCT at the time of IM19 CAR-T cells infusion.
• 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 25 years, either sex;
• Estimated life expectancy \>3 months;
• ECOG performance status of 0 or 1(age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50;
• 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:

• Isolated extramedullary disease relapse；
• Burkitt's lymphoma；
• Patient has obvious symptoms of central nervous system invasion and needs targeted treatment;
• Patient has previously received gene product therapy;
• Patients have 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;
• Patient received chemotherapy or radiotherapy within 3 days before leukapheresis
• Patient used systemic steroids within 5 days before leucapheresis, except those who were recently or currently using inhaled steroids;
• Patients who used drugs to stimulate the production of bone marrow hematopoietic cells within 5 days before leucapheresis;
• Patients have participated in other clinical studies within 1 month before screening or plan to participate in other drug clinical trials during this study;
• Patient received allogeneic cell therapy within 6 weeks before CAR-T cell infusion, such as donor lymphocyte infusion(DLI)；
• History or presence of CNS disorder, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia / hemorrhage / cerebral infarction), brain edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome or mental disease;
• Patients has 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;
• Patients 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

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

• Qian Jiang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu, MD

CONTACT

+8615801390058; wufei@immunochina.com

Study Design

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

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 4, 2022

Record last verified: 2022-03