Trials / Not Yet Recruiting
Not Yet RecruitingNCT06894693
A Phase I Clinical Trial of RS001 in Patients with Relapsed/Refractory B-Cell Malignancies
A Phase I Clinical Trial of RS001 in Patients with Relapsed/Refractory B-Cell Malignancies:
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- Sponsor
- Guangdong Ruishun Biotech Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic profile in the body after infusion of RS001 injection, and preliminary efficacy in subjects with CD19-positive relapsed/refractory B-cell malignancies (BCM).
Detailed description
CD19-positive relapsed/refractory B-cell malignancies (including B-cell non-Hodgkin lymphoma, B-cell acute lymphoblastic leukemia).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RS001 injection | CD19-CAR-mbIL15-DNT Cells. |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2026-04-01
- Completion
- 2028-04-01
- First posted
- 2025-03-25
- Last updated
- 2025-03-25
Source: ClinicalTrials.gov record NCT06894693. Inclusion in this directory is not an endorsement.