Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Recruiting now · Phase 1
Conditions studied: B-Cell Non-Hodgkin Lymphoma-Recurrent, B-Cell Non-Hodgkin Lymphoma-Refractory
In brief
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
Key facts
- Study ID
- NCT06395870
- Run by
- Tianjin Medical University Cancer Institute and Hospital
- People needed
- 33
- Starts
- 2024-05-09
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2024-11-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Aged 18-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
- At least one evaluable tumor lesion according to Lugano 2014 criteria.
- Response to prior therapy is consistent with one of the following:
- Primary refractory.
- Relapsed or refractory after 2 or more lines of therapy.
- 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;
- Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria
You may not qualify if…
- Subject eligible for this study must not meet any of the following criteria:
- 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).
- Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.
- Pregnant or lactating women;
Where it is running
- Oncology Department, The First Affiliated Hospital of USTC west district — Hefei, Anhui, China (enrolling)
- Tianjin Cancer Hospital — Tianjin, China (enrolling)
Full record on ClinicalTrials.gov
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