ACLX-001

Overview

ACLX-001 is a BCMA directed CAR T cell therapy in development for multiple myeloma.

SparkCures ID 363
Developed By Arcellx, Inc.
Generic Name ACLX-001
Treatment Classifications
Treatment Targets

Clinical Trials

All Clinical Trials

View all active clinical trials around the US.

Early Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.

Late Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.

Smoldering Myeloma
Monoclonal Gammopathy of Undetermined Significance (MGUS)

Published Results

Arcellx Presents Continued Robust Long-Term Responses From Its CART-DdBCMA Phase 1 Expansion Trial In Patients With Relapsed Or Refractory Multiple Myeloma At The 2022 ASCO Annual Meeting

June 03, 2022

Evaluable for efficacy and safety analysis were 31 patients, 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 million CAR+ T cells, n=6), the second dose level (300 million CAR+T cells, n=6), and a dose expansion cohort at the recommended Phase 2 dose (RP2D) of 100 million CAR+T cells (n=19). All patients enrolled in the study have poor prognostic factors with 21 of 31 (68%) patients penta-refractory, 12 of 31 (39%) extramedullary disease (EMD), and all 31 patients having had at least three prior treatments.

The interim CART-ddBCMA clinical results (May 3, 2022 cutoff date) demonstrate deep and durable responses in patients with poor prognostic factors.

  • Of the 31 evaluable patients with median follow-up of 12.1 months
    • 100% overall response rate (ORR) achieved in all patients per International Myeloma Working Group criteria
    • 22 of 31 (71%) evaluable patients achieved complete response (CR) or a stringent complete response (sCR)
    • 29 of 31 (94%) patients achieved > very good partial response (VGPR)
    • 2 of 31 (6%) patients achieved a partial response (PR)
    • 12 of 31 (39%) with extramedullary disease
  • 13 of 16 patients (81%) dosed more than 12 months ago reached CR/sCR; 8 (50%) with EMD; 9 (56%) remain in ongoing response with a median follow up of 17.7 months
  • Conversions to sCR have occurred as early as 1 month and also at ≥12 months
  • CART-ddBCMA dosed at RP2D (100 million CAR+T cells) continues to be well-tolerated
    • Toxicities including CRS and ICANS have been manageable, and all resolved with standard management at both dose levels
    • No cases of delayed neurotoxicity events or parkinsonian symptoms
    • No cases of grade 3 (or greater) CRS and only one case (4%) of grade 3 ICANS event with no additional cases from previously reported.

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