Actively Recruiting
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
Led by Technische Universität Dresden · Updated on 2025-08-24
16
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
T
Technische Universität Dresden
Lead Sponsor
G
German Cancer Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years
- Written informed consent
- Willingness and ability to follow the trial protocol
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- For Multiple Myeloma: relapsed or refractory after at least 2 treatment lines including immunomodulatory drug, proteasome inhibitor, and anti-CD38 or SLAMF7 antibody
- For Multiple Myeloma: not eligible for other treatments with known clinical benefit; prior BCMA-targeting immunotherapies allowed
- For Multiple Myeloma: measurable disease defined by specified serum or urine M-Protein or free light chain levels
- For Diffuse Large B-cell Lymphoma (DLBCL): relapsed or refractory after standard therapies or stem cell transplantation or CAR T-cell therapies
- For DLBCL: not eligible for other effective treatments including approved anti-CD19 CAR T-cell therapies
- For DLBCL: measurable disease according to Lugano criteria
- Adequate organ function including specified blood counts, liver enzymes, bilirubin, creatinine, and cardiac function
- Females of childbearing potential must have negative pregnancy test and use effective birth control; males must use effective birth control until 12 months post-treatment
You will not qualify if you...
- Central nervous system involvement by disease
- History of seizures or cerebrovascular events within 12 months
- Autoimmune CNS diseases or ongoing neurologic conditions increasing neurotoxicity risk
- Inadequate lung function requiring continuous oxygen
- Patients on hemodialysis
- Contraindications to Fludarabine or Cyclophosphamide
- Other active malignancies needing treatment except hormonal therapy
- HIV positive
- Active or chronic hepatitis B or C without viral clearance
- Active or recent COVID-19 infection or long COVID syndrome
- Uncontrolled infections requiring inpatient or intravenous therapy
- Active graft-versus-host disease or recent immunosuppressive treatment
- Psychological disorders or drug abuse impairing trial compliance
- Expected deterioration during cell manufacturing despite bridging therapy
- Systemic immunosuppressive treatment exceeding 20 mg Prednisolone per day
- Recent antineoplastic or investigational treatments within specified washout periods
- History of allergic reactions to trial drugs or similar compounds
- Receipt of live vaccines within 2 weeks before treatment
- Pregnant or breastfeeding women
- Women not meeting criteria for childbearing potential exclusion
- Hypersensitivity to drugs used in the trial
- Participation in another interventional trial within 4 weeks
- Addictions or illnesses impairing understanding of trial
- Likely non-adherence to protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Technische Universität Dresden, NCT/UCC, Early Clinical Trial Unit
Dresden, Germany, 01307
Actively Recruiting
Research Team
M
Martin Wermke, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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