Trials / Not Yet Recruiting
Not Yet RecruitingNCT07072247
RN1201 Injection in the Treatment of Antibody-Mediated Diseases
An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection in the Treatment of Antibody-Mediated Diseases
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- Sponsor
- The First Affiliated Hospital of Soochow University · Academic / Other
- Sex
- All
- Age
- 16 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This single-arm, open-label exploratory trial aims to evaluate the safety, feasibility, and preliminary efficacy of RN1201 Injection in patients with antibody-mediated diseases, including refractory immune-mediated platelet transfusion refractoriness (PTR) and relapsed or refractory immune thrombocytopenia (ITP). Patients will receive RN1201 cells infusion following lymphodepletion. The study will assess safety, response rates, B-cell depletion, and immune reconstitution. Exploratory analyses will examine in vivo persistence and activity of RN1201.
Conditions
- Refractory Immune-mediated Platelet Transfusion Refractoriness
- Relapsed or Refractory Immune Thrombocytopenia
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | CD19 and BCMA-targeted allogeneic CAR-T cells | Lymphodepletion chemotherapy followed by CD19 and BCMA-targeted allogeneic CAR-T cells infusion |
Timeline
- Start date
- 2025-07-10
- Primary completion
- 2026-07-30
- Completion
- 2027-07-30
- First posted
- 2025-07-18
- Last updated
- 2025-07-18
Source: ClinicalTrials.gov record NCT07072247. Inclusion in this directory is not an endorsement.