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

Launched by BEIJING IMMUNOCHINA MEDICAL SCIENCE & TECHNOLOGY CO., LTD. · Jun 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IM19 CAR-T cells for adults with recurrent or refractory Non-Hodgkin's Lymphoma (NHL), a type of cancer that affects the lymphatic system. The trial is currently recruiting participants, and it aims to determine how safe and effective this treatment is for patients in China who have not responded well to previous therapies.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of NHL that is either relapsed (came back after treatment) or refractory (did not respond to treatment). They should also have evidence of their disease that can be measured. Participants must be healthy enough to withstand the trial procedures and agree to use effective contraception if they are women of childbearing age. Throughout the trial, participants can expect close monitoring and support from the medical team to ensure their safety. It's important for potential participants to be aware that certain medical conditions or recent treatments may exclude them from joining the trial.

Gender

ALL

Eligibility criteria

• 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.