# Arcellx

> Arcellx is a clinical-stage biotechnology company, now wholly owned by Gilead Sciences and operating within Kite, that developed a compact synthetic protein binder called the D-Domain for engineered cell therapies. Its lead candidate, anitocabtagene autoleucel (anito-cel), is an investigational BCMA-directed autologous CAR-T therapy for relapsed or refractory multiple myeloma; the FDA accepted its biologics license application in 2026. Arcellx also created ARC-SparX, a modular system intended to separate tumor recognition from T-cell activation so treatment can be dosed and controlled.

- **Founded:** 2014
- **Headquarters:** Redwood City, United States
- **Founders:** David Hilbert, Ph.D. (Founder; former CEO and Chief Technical Officer)
- **Team size:** 209 full-time employees as of December 31, 2025, including 133 in research and development; Arcellx became part of Kite in April 2026.
- **Products:** Anitocabtagene autoleucel (anito-cel), D-Domain platform, ddCAR platform, ARC-SparX platform, ACLX-001
- **Notable:** Advanced anito-cel from first-in-human development to an FDA-accepted biologics license application., Reported 96% overall response and 74% complete response or stringent complete response in 117 iMMagine-1 patients at a median 15.9 months of follow-up in December 2025., Received FDA Fast Track, Orphan Drug and Regenerative Medicine Advanced Therapy designations for the lead BCMA CAR-T program.

## Products & services

- **Anitocabtagene autoleucel (anito-cel)** — Investigational autologous BCMA-directed ddCAR T-cell therapy for relapsed or refractory multiple myeloma. The FDA accepted its BLA in 2026; it was not approved as of August 2026.
- **D-Domain platform** — A library-based synthetic binding scaffold used as the target-recognition component of engineered immune-cell therapies; designed to be small, stable and readily expressed.
- **ddCAR platform** — Conventional single-infusion CAR-T candidates that use a D-Domain rather than a traditional scFv antibody fragment for target recognition.
- **ARC-SparX platform** — A modular system pairing universal ARC-T cells with separately dosed SparX proteins, allowing target selection and activity to be controlled through the protein dose.
- **ACLX-001** — Phase 1 ARC-SparX combination targeting BCMA in relapsed or refractory multiple myeloma; Kite exercised an option to negotiate a license.
- **ACLX-002** — Phase 1 ARC-SparX candidate targeting CD123 in acute myeloid leukemia and myelodysplastic syndrome.
- **ACLX-004** — Investigational ARC-SparX program targeting CD33 and CD123 in acute myeloid leukemia; its IND was cleared by the FDA in 2025.

## Achievements

- Advanced anito-cel from first-in-human development to an FDA-accepted biologics license application.
- Reported 96% overall response and 74% complete response or stringent complete response in 117 iMMagine-1 patients at a median 15.9 months of follow-up in December 2025.
- Received FDA Fast Track, Orphan Drug and Regenerative Medicine Advanced Therapy designations for the lead BCMA CAR-T program.
- Raised $142.3 million gross in its February 2022 Nasdaq IPO.
- Formed and expanded a major global development and commercialization partnership with Kite and Gilead.
- Built a pipeline spanning multiple myeloma, AML/MDS, solid tumors and autoimmune disease.
- Ranked No. 6 on the 2025 Fortune Best Workplaces in BioPharma list for small and medium companies.
- Acquired by Gilead in April 2026 in a transaction offering $115 cash plus a potential $5 contingent payment per share.

## Latest updates

- **2026-04** — Gilead completed its acquisition of Arcellx on April 28. Arcellx became a wholly owned subsidiary, its stock was set for delisting, and anito-cel moved forward within Kite.
- **2026-02** — The FDA accepted the anito-cel BLA for adults with relapsed or refractory multiple myeloma and set a target action date of December 23, 2026.
- **2026-02** — Gilead agreed to acquire the Arcellx shares it did not already own for $115 cash per share plus a $5 contingent value right tied to cumulative anito-cel sales.
- **2025-12** — Arcellx reported updated iMMagine-1 results: 96% overall response, 74% complete or stringent complete response, and 82.1% 12-month progression-free survival in 117 patients.
- **2025-09** — Arcellx began dosing patients in a Phase 1 study of anito-cel in generalized myasthenia gravis during the second half of 2025.
- **2025** — The FDA cleared an IND for ACLX-004, an ARC-SparX candidate targeting CD33 and CD123 in acute myeloid leukemia.

## Links

- Website: https://arcellx.com
- LinkedIn: https://www.linkedin.com/company/arcellx
- Twitter/X: https://twitter.com/arcellx

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Last updated: 2026-08-10