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Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up

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Trial Profile

Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 04 Mar 2026

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At a glance

  • Drugs ACLX-001 (Primary) ; Anitocabtagene autoleucel (Primary)
  • Indications Multiple myeloma
  • Focus Adverse reactions; First in man; Proof of concept; Registrational
  • Sponsors Arcellx; Kite Pharma

Most Recent Events

  • 23 Feb 2026 According to a Gilead Sciences media release, the FDA has accepted Anito-cel BLA as a fourth-line treatment for patients with relapsed or refractory multiple myeloma is supported by results from the Phase 1 study (NCT04155749) and the pivotal Phase 2 iMMagine1 study (NCT05396885) and has been accepted by the U.S. Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026.
  • 11 Feb 2026 Planned End Date changed from 1 Jun 2026 to 1 May 2027.
  • 06 Aug 2025 Planned End Date changed from 1 Nov 2035 to 1 Jun 2026.

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