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

• Status: Recruiting
• Trial end date: 2035-06-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Collaborator: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Cyclophosphamide; Fludarabine

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.