NCT06626919RecruitingPhase 1
Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-Oncology Plasma Cell-Related Diseases
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 19 Sept 2024
- Start date
- 30 Apr 2025
- Primary completion date
- Oct 2028
- Lead sponsor
- Kite, A Gilead Company
- Diseases
- Myasthenia gravis
- NCT number
- NCT06626919
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 30 Apr 2025 to the primary completion date, Oct 2028
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- Individual is pregnant or breastfeeding
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Ronald Reagan UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Minnesota Delaware Clinical Research Unit Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| UC Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Stanford Blood and Marrow Transplant Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Lewis Katz School of Medicine at Temple University Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.