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

Phase 1

Recruiting

• Conditions: NHL
• Interventions: Drug: IM19 CAR-T Cells

• Registration Number: NCT04440436
• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

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.

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 Timeline

• Study Start: 2020-06-04
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-08
• Primary Completion: 2022-06-04
• Study Completion: 2035-06-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IM19 CAR-T cells	IM19 CAR-T Cells	IM19 CAR-T cells be administrated in two dose level

Primary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR) at 90 days	90 days	The primary endpoint was ORR 90 days after IM19 infusion

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China