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
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female patients aged ≥ 18 years

• Written informed consent of the subject

• Able and willing to adhere to the trial protocol

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Either Multiple Myeloma (MM):

‣ relapsed or refractory disease after at least 2 lines of treatment including an Immunomodulatory drug, a proteasome inhibitor and an anti-cluster of differentiation 38 antibody or anti-cluster of differentiation 319 (SLAMF7; Elotuzumab) antibody AND

⁃ not eligible for treatment with other regimen available according to local standard of care and known to confer clinical benefit according to the investigator's discretion, prior treatment with other BCMA-targeting immunotherapies (including T-cell engaging antibodies, CAR T-cells and antibody-drug immuno-conjugates) is allowed AND

⁃ measurable disease defined by serum M-Protein ≥ 10 g/l OR urine M-Protein ≥ 200 mg/24h OR serum free light chain \> 100 mg/l of involved free light chain and abnormal serum free light chain ratio

‣ OR

‣ Diffuse large B-cell lymphoma (DLBCL):

⁃ Relapsed after or refractory to standard curative therapy (such as R-CHOP) and refractory to at least one course of standard salvage chemotherapy OR

⁃ Relapsed within one year after high-dose chemotherapy and autologous stem cell support OR

⁃ Relapsed after allogeneic stem-cell transplantation or approved anti-cluster of differentiation 19 CAR T-cell therapies.

‣ AND (applicable to all DLBCL patients)

⁃ Not be eligible for treatment with other regimen available according to local standard of care and known to confer clinical benefit. This includes but is not limited to anti-cluster of differentiation 19 directed CAR T-cell therapies with approved constructs AND (applicable to all DLBCL patients)

⁃ Measurable disease according to Lugano criteria

• Adequate organ function defined as:

‣ Neutrophils ≥ 0.5 Gpt/l and Platelets ≥ 50 Gpt/l (unless due to subtotal infiltration of the bone marrow by underlying malignancy)

⁃ Lymphocytes ≥ 0.1 Gpt/l

⁃ Alaninaminotransferase and Asparataminotransferase ≤ 3.0x Upper limit of normal

⁃ Bilirubin ≤ 1.5x Upper limit of normal

⁃ Creatinine ≤ 1.5x Upper limit of normal

⁃ Adequate cardiac function i.e. left ventricular ejection fraction ≥ 50%, no major valve abnormalities or dyskinesias

• A female of childbearing potential\* may be enrolled providing she has a negative pregnancy test at screening and is routinely using a highly effective method of birth control (pearl index of ≤ 1 required) resulting in a low failure rate (e.g. hormonal contraception, intrauterine device, total sexual abstinence or sterilization). Male patients must also prac-tice a highly effective method of birth control and should not father a child at least until 12 months after infusion of CAR T-cells

Locations
Other Locations
Germany
Technische Universität Dresden, NCT/UCC, Early Clinical Trial Unit
RECRUITING
Dresden
Contact Information
Primary
Martin Wermke, Prof.
carlotta@ukdd.de
+49 351 458 13408
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2027-06
Participants
Target number of participants: 16
Treatments
Experimental: MDC-CAR-BCMA001
MDC-CAR-BCMA001 will be administered intravenously in ascending dose levels. This trial will test a total of 4 dose levels in order to identify the MTD and/or recommended phase 2 dose for MDC-CAR-BCMA001.
Sponsors
Leads: Technische Universität Dresden
Collaborators: German Cancer Research Center

This content was sourced from clinicaltrials.gov