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RECRUITING
NCT06626919
PHASE1

Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases

Sponsor: Kite, A Gilead Company

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-Oncology Plasma Cell-Related Diseases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-04-30

Completion Date

2028-10

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

BIOLOGICAL

anito-cel

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

DRUG

Cyclophosphamide

Administered intravenously

DRUG

Fludarabine

Administered intravenously

Locations (14)

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

UC Irvine Medical Center

Orange, California, United States

Stanford Blood and Marrow Transplant

Palo Alto, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

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

Tampa, Florida, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Minnesota Delaware Clinical Research Unit

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States