Product Description
CART-ddBCMA is a genetically modified cell therapy utilizing a novel synthetic binding domain that is computationally designed, highly stable, and engineered to reduce immunogenicity. CART-ddBCMA was well tolerated and rapid, deep, and durable responses were observed at the first dose level of 100 million cells, with six of six evaluable patients responding per IMWG criteria. (Sourced from: https://www.arcellx.com/arcellx-cart-ddbcma-cell-therapy-demonstrates-deep-and-durable-responses-in-the-treatment-of-relapsed-and-refractory-multiple-myeloma/)
Mechanisms of Action: CAR-T,BCMA
Novel Mechanism: No
Modality: CAR-T
Route of Administration: Intravenous
FDA Designation: Orphan Drug - Multiple Myeloma *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Gilead Sciences
Company Location: FOSTER CITY CA 94404
Company CEO: Daniel P. O’Day
Additional Commercial Interests: Arcellx
Clinical Description
Countries in Clinic: Austria, Belgium, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Gilead Sciences presented P2 Multiple Myeloma results on 2025-06-14 for Anitocabtagene autoleucel
- Clinical Outcomes Reported - Arcellx presented P2 Multiple Myeloma results on 2025-06-14 for Anitocabtagene autoleucel
- Clinical Outcomes Reported - Arcellx presented P2 Multiple Myeloma results on 2024-12-09 for Anitocabtagene autoleucel
Highest Development Phases
Phase 3: Multiple Myeloma
Phase 1: Muscle Weakness|Myasthenia Gravis|Neuromuscular Manifestations
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| ARC-311 | P1 |
Recruiting |
Neuromuscular Manifestations|Myasthenia Gravis|Muscle Weakness |
2027-03-01 |
23% |
2025-01-14 |
Primary Endpoints|Treatments|Trial Status |
| GEM-AnitoFIRST | P2 |
Not yet recruiting |
Multiple Myeloma |
2040-09-30 |
|||
| iMMagine-1 | P2 |
Recruiting |
Multiple Myeloma |
2024-05-31 |
62% |
2024-03-06 |
Primary Endpoints|Treatments |
| KT-US-679-0788 | P3 |
Recruiting |
Multiple Myeloma |
2030-10-31 |
2025-05-02 |
Treatments |
|
| iMMagine-3 | P3 |
Recruiting |
Multiple Myeloma |
2028-07-01 |
91% |
2024-08-23 |
Primary Endpoints|Treatments|Trial Status |