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Clinical Trials in China / NCT04440436
Recruiting Phase 1/2

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

NCT04440436 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd.
Phase
Phase 1/2
Started
2020-06-04
Last updated
2020-12-08

Condition(s) studied

NHL

Investigational drug(s) / intervention(s)

IM19 CAR-T Cells

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

Study 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

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting

More Beijing Immunochina Medical Science & Technology Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04440436 on ClinicalTrials.gov ↗ ← All trials in China