Arcellx Announces Continued Robust Long-Term Responses from its CART-ddBCMA Phase 1 Expansion Trial in Patients with Relapsed or Refractory Multiple Myeloma and Additional Pipeline Progress

— 100% ORR at both CART-ddBCMA dose levels; deep and durable responses observed in patients with poor prognostic factors —

— 27 of 38 (71%) evaluable patients reached CR/sCR; 20 of 25 patients (80%) dosed > 12 months ago or had their 12-month follow-up visit by November 22, 2022 have reached CR/sCR —

— No cases of Grade >3 CRS at RP2D and no delayed neurotoxicity or parkinsonian-like events —

— First patients dosed in iMMagine-1 Phase 2 clinical trial with pivotal drug product —

— Initiated the Phase 1 clinical trial of ACLX-002 for the treatment of patients with AML/MDS —

— Management to host a live webcast event with an expert panel of clinicians to discuss the CART-ddBCMA clinical results on Sunday, December 11, 2022, at 11:00 AM CT —

Excerpt from the Press Release:

REDWOOD CITY, Calif., Dec. 9, 2022 /PRNewswire/ — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced continued robust long-term responses from its CART-ddBCMA Phase 1 expansion trial in patients with relapsed or refractory multiple myeloma, dosing of first patients in its iMMagine-1 Phase 2 clinical trial with pivotal drug product, and the initiation of the Phase 1 clinical trial of ACLX-002 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).

38 patients were evaluable for efficacy and safety analysis as of the October 31, 2022 cutoff date, based on follow-up of at least one month, following treatment. These evaluable patients comprised the dose escalation cohorts for the first dose level (100 (+/- 20) million CAR+ T cells, n=6) and the second dose level (300 (+/- 20) million CAR+ T cells, n=6), and a dose expansion cohort at 100 (+/- 20) million CAR+ T cells (n=26). The median dose administered to patients in the first dose level and dose expansion cohorts was 115 million CAR+ T cells.  All patients evaluable for this analysis have poor prognostic factors with 38 of 38 (100%) patients triple-refractory, 26 of 38 (68%) penta-refractory, and 22 of 38 (58%) with at least one high-risk prognostic factor (extramedullary disease (EMD), ISS Stage 3 [beta-2-microglobulin ≥5.5], bone marrow plasma cells (BMPC) ≥60%). All 38 patients had at least 3 prior lines of therapy. 

The interim CART-ddBCMA Phase 1 clinical results (October 31, 2022 cutoff date) demonstrate deep and durable responses in patients with poor prognostic factors. Based on these data, the recommended Phase 2 dose (RP2D) was selected to be 115 (+/- 10) million CAR+T cells.

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