Actively Recruiting
Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting 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
N/A
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
Researchers are evaluating the safety and maximum tolerated dose of MDC-CAR-BCMA001, which are high-affinity autologous BCMA-targeting CAR T-cells, in patients with relapsed and refractory B-cell malignancies. This phase I trial focuses on diseases such as multiple myeloma and diffuse large B-cell lymphoma that have not responded to previous treatments or have relapsed after therapy. The goal is to determine if this genetic therapy can be administered safely and to find the appropriate dose for future studies. The study involves giving participants a single intravenous infusion of MDC-CAR-BCMA001 following conditioning chemotherapy. The treatment will be tested at four increasing dose levels to identify the maximum tolerated dose or recommended dose for phase II trials. This dose escalation approach helps to evaluate safety and tolerability at different levels of the CAR T-cell therapy. Participants will be closely monitored for approximately 24 months to assess safety outcomes, including the incidence and severity of adverse events, serious adverse events, cytokine release syndrome, neurotoxicity, and dose-limiting toxicities. Researchers will conduct regular evaluations during this period to track these effects and determine the optimal dose. The total participation time and follow-up will help ensure thorough safety assessments throughout the trial.
CONDITIONS
Brief 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 or older
- Written informed consent given
- Able and willing to follow the trial protocol
- ECOG performance status of 0 to 2
- For Multiple Myeloma: relapsed or refractory after at least 2 prior treatments including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 or anti-SLAMF7 antibody
- For Multiple Myeloma: not eligible for other standard treatments known to provide clinical benefit
- For Multiple Myeloma: measurable disease by serum or urine M-protein or involved free light chain levels
- For Diffuse Large B-cell Lymphoma (DLBCL): relapsed or refractory after standard therapies and salvage chemotherapy, or relapsed after stem cell transplantation or CAR T-cell therapies
- For DLBCL: not eligible for other standard treatments known to provide clinical benefit
- For DLBCL: measurable disease by Lugano criteria
- Adequate organ function including specified blood counts, liver enzymes, bilirubin, creatinine, and cardiac function
- Women of childbearing potential must have a negative pregnancy test and use highly effective birth control; men must use highly effective birth control for 12 months post-infusion
You will not qualify if you...
- Central nervous system involvement by the disease
- History of seizures or cerebrovascular events in the past 12 months
- Autoimmune CNS diseases
- Ongoing neurological conditions that increase neurotoxicity risk or impair assessment
- Inadequate lung function needing continuous oxygen
- Patients on hemodialysis
- Contraindications to Fludarabine or Cyclophosphamide
- Other active cancers requiring treatment except hormonal therapy
- HIV positive
- Active or chronic hepatitis B or C unless infection cleared
- Active or recent COVID-19 infection or long COVID syndrome
- Uncontrolled infections requiring inpatient or intravenous antibiotics
- Active graft-versus-host disease or recent immunosuppressive treatment
- Psychological disorders or substance abuse impairing protocol compliance
- Expected health deterioration despite bridging therapy
- Need for systemic immunosuppressive drugs exceeding specified doses
- Recent cancer treatments or investigational therapies within defined timeframes
- Allergic reactions to trial drugs or ingredients
- Receipt of live vaccines within 2 weeks prior to therapy
- Pregnant or breastfeeding women; breastfeeding must stop before and during treatment
- Women not meeting strict contraceptive or menopausal criteria
- Known hypersensitivity to trial drugs or similar
- Participation in other interventional trials recently
- Addictions or illnesses impairing informed consent
- Likely non-adherence to the trial protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive a single-dose intravenous infusion of MDC-CAR-BCMA001 following conditioning chemotherapy to treat relapsed or refractory B-cell malignancies.
1 infusion visit and multiple follow-up visits during treatment period
Duration - Up to 24 months after treatment
Participants are monitored for safety, including adverse events, cytokine release syndrome, neurotoxicity, and dose-limiting toxicities after treatment.
Multiple follow-up visits over 24 months
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.
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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