OncoMatch/Clinical Trials/NCT05836896
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
Is NCT05836896 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies non-drug interventions for neoplasms.
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
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunomodulatory drug
relapsed or refractory disease after at least 2 lines of treatment including an Immunomodulatory drug
Must have received: proteasome inhibitor
relapsed or refractory disease after at least 2 lines of treatment including ... a proteasome inhibitor
Must have received: anti-CD38 antibody
relapsed or refractory disease after at least 2 lines of treatment including ... an anti-cluster of differentiation 38 antibody
Lab requirements
Blood counts
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
Kidney function
Creatinine ≤ 1.5x Upper limit of normal
Liver function
Alaninaminotransferase and Asparataminotransferase ≤ 3.0x Upper limit of normal; Bilirubin ≤ 1.5x Upper limit of normal
Cardiac function
left ventricular ejection fraction ≥ 50%, no major valve abnormalities or dyskinesias
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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