Evaluating IM19 CAR-T cell therapy for patients with recurrent Non-Hodgkin's Lymphoma
Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma
This study is testing a new CAR-T cell therapy called IM19 to see if it can safely help adults with recurrent Non-Hodgkin's Lymphoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Immunochina Medical Science & Technology Co., Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04440436 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the safety and efficacy of IM19 CAR-T cell therapy in adults with recurrent or refractory Non-Hodgkin's Lymphoma (NHL). The study consists of two phases: a phase I single-center study focused on safety evaluation, followed by a phase II multi-center study aimed at determining the treatment's efficacy. Participants will receive IM19 CAR-T cells, which are engineered to target CD19-positive cancer cells. The trial is conducted in China and aims to provide insights into a novel treatment option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory CD19-positive Non-Hodgkin's Lymphoma.
Not a fit: Patients with gastrointestinal lymph node or central nervous system involvement, or those with autoimmune conditions requiring immunosuppressants, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a new treatment option for patients with difficult-to-treat Non-Hodgkin's Lymphoma.
How similar studies have performed: Other studies involving CAR-T cell therapies have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yuqin Song, MD, PhD — Peking University Cancer Hospital & Institute
- Study coordinator: Fei Wu, MD
- Email: wufei@immunochina.com
- Phone: +8615801390058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.