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

Beijing Immunochina Medical Science & Technology

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

NHL

Treatments

Drug: IM19 CAR-T Cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT04440436

SD45

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.