Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hod
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-E9D,LUCAR-E9K, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
| Condition(s) | B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma Refractory |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-E9D,LUCAR-E9K, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. |
| Who can participate | 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. 6. Response to prior therapy is consistent with one of the following: 1） Patients with B-NHL who are primary refractory and are unsuitable or unwilling to receive autologous CAR-T cell therapy; 2） primary refractory is defined as the best response to first-line treatment being SD or PD; 3） Relapse withi |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Beijing GoBroad Hospital |
| Locations | Hefei, China; Xi'an, China; Xuzhou, China |
| Start date | 2025-08-05 |
| NCT ID | NCT07093411 |
| Official listing | https://clinicaltrials.gov/study/NCT07093411 |