NCT06626919 Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
| NCT ID | NCT06626919 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kite, A Gilead Company |
| Condition | Muscular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-04-30 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Kite Study Director
STUDY DIRECTOR
Kite, A Gilead Company
Frequently Asked Questions
Who can join the NCT06626919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Muscular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06626919 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06626919 currently recruiting?
Yes, NCT06626919 is actively recruiting participants. Contact the research team at medinfo@kitepharma.com for enrollment information.
Where is the NCT06626919 trial being conducted?
This trial is being conducted at Los Angeles, United States, Orange, United States, Palo Alto, United States, Tampa, United States and 10 additional locations.
Who is sponsoring the NCT06626919 clinical trial?
NCT06626919 is sponsored by Kite, A Gilead Company. The principal investigator is Kite Study Director at Kite, A Gilead Company. The trial plans to enroll 30 participants.