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

ConditionsNeoplasms Relapsed Diffuse Large B-cell Lymphoma (DLBCL)Refractory Diffuse Large B-cell Lymphoma (DLBCL)Multiple Myeloma, Refractory Multiple Myeloma in Relapse

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorTechnische Universität Dresden

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Any Central nervous system (CNS)-involvement by underlying disease

History of seizure or cerebrovascular ischemia / hemorrhage within the last 12 months

History of any autoimmune Central nervous system disease (e.g. multiple sclerosis, amyotrophic lateral sclerosis, optic neuritis)

Ongoing neurologic conditions that in the opinion of the investigator might increase the risk for neurotoxicity or impair the assessment of CAR-associated neurotoxicity

Trial design

Treatments tested in this trial

MDC-CAR-BCMA001 (BCMA directed CAR T-cells)

Treatment groups

16 Participants

are divided into 1 treatment group

Sponsors and collaborators

Technische Universität Dresden

Lead sponsor

German Cancer Research Center

Collaborator

Source ClinicalTrials.gov