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Arcellx, Inc.

Rare disease drugmaker · part of Gilead Sciences · based in United States · kitepharma.com

Arcellx, Inc. works on 3 rare diseases we track, including Acute Myeloid Leukemia, Multiple Myeloma and 1 more. It has 4 active clinical trials, though none are looking for new volunteers right now.

Arcellx is a cell therapy company that developed anitocabtagene autoleucel (anito-cel), an investigational CAR T-cell therapy for multiple myeloma. Gilead Sciences completed its purchase of Arcellx on April 28, 2026, and anito-cel is now developed by Kite, Gilead's cell therapy company. The FDA is reviewing anito-cel for adults whose multiple myeloma has come back or stopped responding after earlier treatment, with a decision due December 23, 2026.

Arcellx, Inc. pipeline

Each row lists the diseases Arcellx, Inc. is studying at that stage, from the ones closest to approval down to the earliest work.

Phase 3
Large studies, usually the last step before a company asks the FDA for approval.
Phase 2
Mid-size studies that check whether a drug works and at what dose.
Phase 1
First studies in people, mostly checking safety.

Arcellx, Inc. clinical trials

These are Arcellx, Inc. trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.

4 trials underway, not taking new volunteers

Underway, not taking new volunteersPhase 1Recently updatedNCT05457010

Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome.

Tests SPRX002, ARC-T Cells, Cyclophosphamide, Fludarabine

For Acute Myeloid Leukemia and Myelodysplastic Syndromes

Master Protocol: The main goal of this master clinical trial study is to assesses the safety, tolerability, pharmacokinetic (PK), Pharmacodynamic (PD) in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The goal of the Arm 1 study is to assess the safety, tolerability, PK, and PD of the study drugs, Antigen Receptor Complex T (ARC-T) cells and CD123-specific soluble protein antigen-receptor X-linker (SPRX002), in participants with relapsed or refractory AML or MDS. The primary objective of this study is to assess the safety profile (including any dose-limiting toxicity (DLT)), to determine recommended Phase 2 dose (RP2D) of the investigational agents when infused in participants with relapsed and refractory AML or MDS.

Ages 18 Years+5 locations
View full study
Underway, not taking new volunteersPhase 3Updated a few months agoNCT06413498

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

Tests Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib, Dexamethasone, Daratumumab, Carfilzomib

For Multiple Myeloma

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

Ages 18 Years+117 locations
View full study
Underway, not taking new volunteersPhase 2No updates in a whileNCT05396885

Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)

Tests anitocabtagene-autoleucel

For Multiple Myeloma

A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.

Ages 18 Years+18 locations
View full study
Underway, not taking new volunteersPhase 1No updates in a whileNCT04155749

Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma

Tests anitocabtagene-autoleucel

For Relapsed and Refractory Multiple Myeloma

Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.

Ages 18 Years+4 locations
View full study
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More about Arcellx, Inc.

As a rare disease specialist, Arcellx, Inc. has active clinical trial programs and drug development efforts across 3 rare diseases, including Acute Myeloid Leukemia, Multiple Myeloma, Myelodysplastic Syndromes. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.

The clinical trials section below shows active and recruiting rare disease studies sponsored by Arcellx, Inc., sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites.

The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.

Arcellx, Inc. is headquartered in United States, a subsidiary of Gilead Sciences. The company dedicates its research and development resources exclusively to rare and orphan diseases, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.

Where Arcellx, Inc. trials take place

The trials above run at 144 study sites in 15 countries. Tap a country to see its states, cities and hospitals.

United States
73▼
Spain
11▼
France
10▼
Germany
8▼
Japan
6▼
United Kingdom
6▼
Australia
5▼
Italy
5▼
Austria
4▼
Belgium
4▼
Canada
4▼
Netherlands
3▼

Rare diseases Arcellx, Inc. works on

Each disease page lists every open trial, not only Arcellx, Inc.'s, plus approved treatments.

Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a fast-growing cancer of the bone marrow in which immature white blood cells called blasts crowd out normal blood cells, causing fatigue, infections and bleeding...

How common: The National Cancer Institute's SEER program estimates 22,720 new US cases and 11,500 deaths in 2026, about 1.1% of new cancers, and 83,311 people were living with AML in 2023

Multiple Myeloma

Multiple myeloma is a cancer of plasma cells, the white blood cells that make antibodies.

How common: About 36,000 new US diagnoses expected in 2026 and roughly 203,000 people living with it, which puts myeloma right at the edge of the US rare disease threshold; it is 1.7% of all new cancers (NCI SEER)

Myelodysplastic Syndromes

Myelodysplastic syndromes are a group of blood cancers in which the bone marrow fails to produce enough healthy blood cells.

How common: 10,000 to 15,000 new cases annually in the U.S.; estimated 60,000 to 170,000 Americans living with MDS

Where to get support

Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. Arcellx, Inc.'s own site is kitepharma.com, and our help paying for treatment page lists drugmaker programs and charity funds.

Questions about Arcellx, Inc.