Clinical trial · Interventional
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
NCT06626919CI-TRIAL-00104020recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune | — | UNRESOLVED | — |
| Autoimmune Diseases | — | UNRESOLVED | — |
| Autoimmune Diseases of the Nervous System | — | UNRESOLVED | — |
| Muscle Weakness | — | UNRESOLVED | — |
| Muscular Diseases | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Neuromuscular Manifestations | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anito-cel | Biological | — | UNRESOLVED |
| Standard Lymphodepletion regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anito-cel
- description
- Single dose of anito-cel cells infused intravenously
- interventionNames
- Biological: anito-cel
- Drug: Standard Lymphodepletion regimen
Primary outcomes (2)
- measure
- Assess safety profile, including any DLT and MTD (if applicable)
- timeFrame
- 24 months
- description
- Type, incidence, and severity of treatment-emergent adverse events (TEAEs), including DLT(s) and laboratory abnormalities
- measure
- Selection of RP2D
- timeFrame
- 24 months
- description
- Evaluate the MTD and establish the RP2D
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject must be 18 years of age or older * Must have MGFA clinical classification Grades 2-4A at time of screening * Subject must have clinically active disease and requiring ongoing therapy for GMG * MG-ADL score 6 and QMG score \>10 at screening * GMG specific autoantibodies must be above the reference laboratory ULN Exclusion Criteria: * Subject 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
References
Publications (0)
Data not yet available
No reference posted for this study.