Trials / Recruiting
RecruitingNCT06414135
Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis
A Dose Ranging Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Relmacabtagene Autoleucel (Relma-cel) in Patients With Refractory/Progressive Systemic Sclerosis
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- Liangjing Lu · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis. Efficacy will be explored too. If enrolled, participants will undergo leukapheresis, lymphodepleting chemotherapy and administration of Relma-cel.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Relma-cel | All participants will receive Relma-cel once at different dose levels: 25×10\^6 CAR+ T cells、50×10\^6 CAR+ T cells、75×10\^6 CAR+ T cells |
Timeline
- Start date
- 2024-06-12
- Primary completion
- 2025-05-01
- Completion
- 2027-04-01
- First posted
- 2024-05-16
- Last updated
- 2024-08-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06414135. Inclusion in this directory is not an endorsement.