Recruiting
Phase 1

Anitocabtagene Autoleucel

Sponsor:

Kite, A Gilead Company

Code:

NCT06626919

Conditions

Muscular Diseases

Neuromuscular Manifestations

Autoimmune

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

anito-cel

Cyclophosphamide

Fludarabine

Study Details

Brief summary:

The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis (GMG). Anito-cel is a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy.

The primary objective of this study is to assess the safety profile, including any dose-limiting toxicity (DLT) and identification of a maximum tolerated dose (MTD) (if applicable), to support selection of the recommended Phase 2 dose (RP2D) of anito-cel when administered to participants with GMG.

Conditions

Muscular Diseases

Neuromuscular Manifestations

Autoimmune

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Study ID

NCT06626919

Start date

Apr 30, 2025

Status verified date

Oct, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Individuals must be 18 years of age or older
  • Must have Myasthenia Gravis Foundation of America (MGFA) clinical classification Grades 2-4A at time of screening
  • Participant must have clinically active disease and requiring ongoing therapy for Generalized Myasthenia Gravis (GMG)
  • MG-ADL score ≥ 6 and QMG score ≥ 10 at screening
  • GMG specific autoantibodies must be above the reference laboratory upper limit of normal (ULN)

Key Exclusion Criteria:

  • Individual is pregnant or breastfeeding
  • Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide within the specified time frame prior to leukapheresis or prior to anito-cel infusion
  • Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager
  • Previous thymectomy within 6 months of screening
  • Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Anito-cel (Dose Escalation)

Participant will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of anito-cel. Anito-cel will be given at one of several possible doses in dose escalation until the optimal dose is identified.

experimental: Anito-cel (Dose Expansion)

Participant will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of anito-cel. Anito-cel will be given at the optimal dose identified in dose escalation.

Interventions

anito-cel

Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain

Cyclophosphamide

Administered intravenously

Fludarabine

Administered intravenously

Primary outcome measure

  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) [ Time Frame: First dose date up to 24 months ]
  • Percentage of Participants Experiencing Dose-Limiting Toxicities (DLT) [ Time Frame: Up to 28 days following anito-cel infusion ]
  • Maximum Tolerated Dose (MTD) of Anito-cel [ Time Frame: First dose up to 30 days (Up to 24 months) ]
  • Percentage of Participants With Laboratory Abnormalities [ Time Frame: First dose date up to 24 months ]
  • Recommended Phase 2 Dose (RP2D) of Anito-cel [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Medical Information

844-454-5483(1-844-454-KITE)medinfo@kitepharma.com

Locations

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

UC Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Stanford Blood and Marrow Transplant

Recruiting

Palo Alto, California, United States, 94305

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare

Recruiting

Tampa, Florida, United States, 33612

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

University of Minnesota Delaware Clinical Research Unit

Recruiting

Minneapolis, Minnesota, United States, 55455

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Lewis Katz School of Medicine at Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Kite, A Gilead Company

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • ARC-311
  • CART
  • CAR-T
  • BCMA
  • Anito-cel
  • Generalized Myasthenia Gravis
  • gMG
  • MG
  • Myasthenia Gravis
  • non-oncology plasma cell
  • autoimmune
  • auto-antibody
  • chimeric antigen receptor
  • D-Domain chimeric antigen receptor
  • B-cell maturation antigen (BCMA)
  • anitocabtagene autoleucel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Kite, A Gilead Company on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.