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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

ConditionsNeoplasmsRelapsed Diffuse Large B-cell Lymphoma (DLBCL)Refractory Diffuse Large B-cell Lymphoma (DLBCL)Multiple Myeloma, RefractoryMultiple 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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

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

    Genetic

    Single-dose intravenous infusion of MDC-CAR-BCMA001 at the respective dose level following a conditioning chemotherapy

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: MDC-CAR-BCMA001Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD) of MDC-CAR-BCMA001

The MTD will be defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate.

Time frame
appr. 24 months
2

Incidence and severity of adverse events and serious adverse events

graded according to Common Terminology Criteria of Adverse Events V5.0

Time frame
appr. 24 months
3

Incidence and severity of Cytokine release syndrome

Grading of Cytokine release syndrome according to American Society for Transplantation and Cellular Therapy consensus criteria

Time frame
appr. 24 months
4

Incidence and severity of Immune effector cell-associated neurotoxicity syndrome

Grading of Immune effector cell-associated neurotoxicity syndrome according to American Society for Transplantation and Cellular Therapy consensus criteria

Time frame
appr. 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Technische Universität Dresden

Lead sponsor

German Cancer Research Center

Collaborator

Source ClinicalTrials.gov
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