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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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NHL

Intervention / Treatment
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* Drug: IM19 CAR-T Cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IM19 CAR-T cells<br>IM19 CAR-T cells be administrated in two dose level | Drug: IM19 CAR-T Cells<br>* 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<br>* Other names: Cyclophosphamide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate(ORR) at 90 days | The primary endpoint was ORR 90 days after IM19 infusion | 90 days |