Clinical Trial

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

Study acronym: CARLOTTA01
Recruiting Phase 1
View on ClinicalTrials.gov →
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
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-04-19; most recent amendment 2025-08-22.
Status change: Not Yet Recruiting → Recruiting 2024-02-19
Trial Details
NCT Number NCT05836896
Lead Sponsor Technische Universität Dresden
Collaborators: German Cancer Research Center
Conditions Neoplasms, Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma, Refractory, Multiple Myeloma in Relapse
Enrollment 16 participants
Start Date 2024-02-15
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-24