Evaluating IM19 CAR-T cell therapy for patients with recurrent Non-Hodgkin's Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

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  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

  This trial tries loncastuximab tesirine with rituximab as a bridge before commercial CD19 CAR‑T therapy for adults with relapsed or refractory large B‑cell lymphoma to see if it is safe and helps control disease before CAR‑T.

  Recruiting at 2 sites Phase 2 University of Utah · Chapel Hill, North Carolina and 1 other locations · NCT06788964

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.