Trials / Recruiting
RecruitingNCT05836896
A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed and Refractory B-cell Malignancies
A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting CAR T-cells in Patients With Relapsed and Refractory B-cell Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- Technische Universität Dresden · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this phase I study is to determine whether MDC-CAR-BCMA001 (BCMA directed CAR T-cells) is safe and tolerable in the treatment of relapsed and refractory B-cell malignancies
Conditions
- Neoplasms
- Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
- Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- Multiple Myeloma, Refractory
- Multiple Myeloma in Relapse
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | MDC-CAR-BCMA001 (BCMA directed CAR T-cells) | Single-dose intravenous infusion of MDC-CAR-BCMA001 at the respective dose level following a conditioning chemotherapy |
Timeline
- Start date
- 2024-02-15
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2023-05-01
- Last updated
- 2025-08-24
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05836896. Inclusion in this directory is not an endorsement.