Dr Farid on Current and Future Investigations of MDC-CAR-BCMA001 in Myeloma and AL Amyloidosis

"We are looking forward to the ongoing [phase 1] CARLOTTA001 trial [being conducted] by our colleagues from Dresden, Germany. We are also going to launch a phase 1 trial called CLEAR-AL, [which will evaluate the use of MDC-CAR-BCMA001 in patients with] relapsed/refractory AL amyloidosis as early as in the second line of treatment."

Kiavasch Mohammad Nejad Farid, MD, of Heidelberg University Hospital, discusses next steps for evaluating the novel second-generation BCMA-directed CAR T-cell construct MDC-CAR-BCMA001 in patients with relapsed/refractory multiple myeloma and systemic light chain (AL) amyloidosis.

Findings from a study investigating compassionate use of the in-house–manufactured BCMA-targeted CAR T-cell construct MDC-CAR-BCMA001 in patients with BCMA-pretreated,triple-class–refractory multiple myeloma and AL amyloidosis were presented at the 51st Annual EBMT Meeting. Data demonstrated clinical activity of MDC-CAR-BCMA001 among heavily pretreated patients in the overall study population, including those with limited treatment options due to AL amyloidosis, a setting where CAR T-cell therapy is not yet approved.

These preliminary findings support the ongoing phase 1 CARLOTTA001 trial (NCT05836896), led by investigators in Dresden, Germany, Farid detailed. CARLOTTA001 is currently enrolling patients aged 18 years or older with relapsed/refractory diffuse large B-cell lymphoma or multiple myeloma. Eligible patients must have an ECOG performance status of 0 to 2 and adequate organ function. Upon enrollment, patients will receive lymphodepleting conditioning chemotherapy followed by a single intravenous infusion of MDC-CAR-BCMA001 administered at 1 of 4 dose levels in an ascending dose-escalation design. Primary end points of the study include identification of the maximum tolerated dose (MTD) and safety.

To further define the feasibility and therapeutic activity of MDC-CAR-BCMA001 in AL amyloidosis, particularly in the second-line setting, the phase 1 CLEAR-AL trial is being initiated, Farid continued. This study aims to expand upon the compassionate-use data and provide insight into the potential role of BCMA-directed CAR T-cell therapy in patients with this rare plasma cell disorder. Collectively, these trials may help delineate the future integration of CAR T-cell therapy in the management of AL amyloidosis and relapsed/refractory plasma cell malignancies.

Disclosures: Farid reported receiving travel grants from Pierre Fabre and Kite/Gilead.