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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

NCT05836896 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-08-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • German Cancer Research Center

    collaborator OTHER

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Martin Wermke, Prof. · Technische Universität Dresden (TUD)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05836896 on ClinicalTrials.gov