RECRUITING

A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.

Official Title

A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases

Quick Facts

Study Start:2025-01
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06626919

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject must be 18 years of age or older
  2. * Must have MGFA clinical classification Grades 2-4A at time of screening
  3. * Subject must have clinically active disease and requiring ongoing therapy for GMG
  4. * MG-ADL score 6 and QMG score \>10 at screening
  5. * GMG specific autoantibodies must be above the reference laboratory ULN
  1. * Subject is pregnant or breastfeeding
  2. * 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
  3. * Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager
  4. * Previous thymectomy within 6 months of screening
  5. * Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator

Contacts and Locations

Study Contact

Clinical Information
CONTACT
240-327-0379
clinical@arcellx.com

Study Locations (Sites)

University of California, Irvine
Orange, California, 92602
United States

Collaborators and Investigators

Sponsor: Arcellx, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01
Study Completion Date2028-04

Study Record Updates

Study Start Date2025-01
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Muscular Diseases
  • Neuromuscular Manifestations
  • Autoimmune
  • Autoimmune Diseases
  • Autoimmune Diseases of the Nervous System
  • Myasthenia Gravis
  • Muscle Weakness