Treatment for relapsed or refractory B-cell non-Hodgkin lymphoma using dual-targeted cells

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 phase I, open-label clinical study evaluates the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation that targets CD19 and CD20, in patients aged 18 to 75 with relapsed or refractory B-cell non-Hodgkin lymphoma. Participants will undergo a screening phase followed by lymphodepleting chemotherapy before receiving a single dose of the LUCAR-G39D injection. The study will assess the treatment's effects through various phases, including follow-up to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.

Response to prior therapy is consistent with one of the following:

1. Primary refractory.
2. Relapsed or refractory after 2 or more lines of therapy.
3. For LBCL, 3B FL. t-iNHL:

   * Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
   * Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;

     7\. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria

   Exclusion Criteria:

   Subject eligible for this study must not meet any of the following criteria:

   1\. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).

   6\. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.

   7\. Pregnant or lactating women;

Where it's running

• Oncology Department, The First Affiliated Hospital of USTC west district
  Hefei, Anhui, China Recruiting
• Tianjin Cancer Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Huilai Zhang
• Email: huilaizhangtz@163.com
• Phone: +86-18622221228

Similar studies

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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.