RecruitingPhase 1Phase 2NCT04440436

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

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


Sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Enrollment

52 participants

Start Date

Jun 4, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental CAR-T cell therapy (called IM19) in people with relapsed or treatment-resistant non-Hodgkin's lymphoma whose cancer cells carry a protein called CD19. **You may be eligible if...** - You have non-Hodgkin's lymphoma that has come back or stopped responding to treatment - Your cancer cells are confirmed to be CD19-positive - You have received prior standard treatments - You are 18 or older **You may NOT be eligible if...** - You have lymphoma involving the central nervous system - You have had a bone marrow or stem cell transplant and are experiencing graft-versus-host disease - You have active uncontrolled infections including HIV or hepatitis - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIM19 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


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT04440436


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