Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients

Sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04440436
Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)
52
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180
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Study Details

Study Description

Brief Summary

This is a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.

Condition or Disease Intervention/Treatment Phase
  • Drug: IM19 CAR-T Cells
Phase 1/Phase 2

Detailed Description

This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma
Actual Study Start Date :
Jun 4, 2020
Anticipated Primary Completion Date :
Jun 4, 2022
Anticipated Study Completion Date :
Jun 4, 2035

Arms and Interventions

Arm Intervention/Treatment
Experimental: IM19 CAR-T cells

IM19 CAR-T cells be administrated in two dose level

Drug: IM19 CAR-T Cells
IM19 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days
Other Names:
  • Fludarabine
  • Cyclophosphamide
  • Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate(ORR) at 90 days [90 days]

      The primary endpoint was ORR 90 days after IM19 infusion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.

    • CD20 positive patients undergo corresponding targeted therapy.

    • Patients must have evaluable evidence of disease (according to Lugano 2014 standards).

    • ≥ 18 years old.

    • The expected survival period is more than 3 months.

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    • Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up

    • Participate voluntarily in this experiment and sign the informed consent.

    Exclusion Criteria:
    • The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment.

    • Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease

    • Subject has used chemotherapy or radiotherapy within three days before the blood collection period.

    • Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).

    • Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection

    • Subject has used any gene therapy products before.

    • Subject with a history of epilepsy or other central nervous system diseases.

    • Active Hepatitis B Virus or Hepatitis C Virus infections

    • The subject with other tumors in the past 5 years.

    • Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Cancer Hospital Beijing Beijing China

    Sponsors and Collaborators

    • Beijing Immunochina Medical Science & Technology Co., Ltd.
    • Jiangsu Simcere Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: Yuqin Song, MD, PhD, Peking University Cancer Hospital & Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Immunochina Medical Science & Technology Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04440436
    Other Study ID Numbers:
    • SD45
    First Posted:
    Jun 19, 2020
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 8, 2020