Trials / Recruiting
RecruitingNCT06395870
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39D in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39D injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | LUCAR-G39D cells product | Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. |
Timeline
- Start date
- 2024-05-09
- Primary completion
- 2026-06-30
- Completion
- 2028-06-30
- First posted
- 2024-05-02
- Last updated
- 2024-11-06
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06395870. Inclusion in this directory is not an endorsement.