Anitocabtagene Autoleucel for Myasthenia Gravis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Arcellx, Inc.

Must not be taking: Anti-CD20, Calcineurin, FcRN, others

Disqualifiers: Pregnant, Breastfeeding, Gene therapy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Will I have to stop taking my current medications?

The trial requires stopping certain medications like Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide before participating. The protocol does not specify other medications, so it's best to discuss with the trial team.

Eligibility Criteria

This trial is for adults with active generalized myasthenia gravis (GMG), a muscle weakness disease. Participants must be over 18, have moderate to severe symptoms, and show specific GMG autoantibodies above normal levels.

Inclusion Criteria

I am 18 years old or older.

My GMG specific autoantibodies are above the normal range.

My MG symptoms moderately impact my daily life and my muscle strength is significantly affected.

+2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment (Leukapheresis)

Participants undergo leukapheresis to collect cells for CAR-T cell manufacturing

1 week

Pretreatment with Lymphodepletion Chemotherapy

Participants receive lymphodepletion chemotherapy prior to CAR-T cell infusion

1 week

Treatment

Participants receive a single infusion of anito-cel and are monitored for safety and efficacy

4 weeks

Weekly visits for safety monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits as per study protocol

Optional Bridging Therapy

Participants may receive bridging therapy while anito-cel is being manufactured

Participant Groups

The study tests anito-cel, a CAR-T cell therapy targeting BCMA in patients with GMG. It's a Phase 1 trial that gradually increases doses to assess safety and early signs of effectiveness alongside standard lymphodepletion treatment.

1Treatment groups

Experimental Treatment

Group I: anito-celExperimental Treatment2 Interventions

Single dose of anito-cel cells infused intravenously