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: Autologous 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: Western America
Company Founding Year: 1987
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
- Gilead Sciences plans to acquire Arcellx with a $7.8 billion deal, focusing on the FDA-approved anito-cel with a PDUFA date of December 23, 2026.
- Clinical Outcomes Reported - Arcellx presented P0 Multiple Myeloma results on 2026-02-05 for Anitocabtagene autoleucel
- Clinical Outcomes Reported - Gilead Sciences presented P2 Multiple Myeloma results on 2025-12-06 for Anitocabtagene autoleucel
Highest Development Phases
Phase 3: Multiple Myeloma
Phase 1: Muscle Weakness|Myasthenia Gravis|Neuromuscular Manifestations
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06626919 |
ARC-311 | P1 |
Recruiting |
Neuromuscular Manifestations|Myasthenia Gravis|Muscle Weakness |
2027-03-01 |
50% |
2025-01-14 |
Primary Endpoints|Treatments|Trial Status |
NCT05396885 |
iMMagine-1 | P2 |
Active, not recruiting |
Multiple Myeloma |
2026-12-01 |
62% |
2025-12-19 |
Patient Enrollment|Primary Endpoints|Start Date|Treatments |
2024-517020-18-00 |
GEM-AnitoFIRST | P2 |
Not yet recruiting |
Multiple Myeloma |
2040-09-30 |
|||
2024-511188-26-00 |
KT-US-679-0788 | P3 |
Recruiting |
Multiple Myeloma |
2030-10-31 |
2025-05-02 |
Treatments |
|
NCT06413498 |
iMMagine-3 | P3 |
Recruiting |
Multiple Myeloma |
2028-07-01 |
26% |
2024-08-23 |
Primary Endpoints|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
03/03/2026 |
News Article |
Immunotherapy Delivers Across Tumor Types as Oncology Market Eyes $750 Billion |
|
02/10/2026 |
News Article |
Gilead Sciences Announces Fourth Quarter and Full Year 2025 Financial Results |
|
02/04/2026 |
News Article |
Arcellx Announces Late-Breaking Presentation at TANDEM Demonstrating Unique, High Target-Specificity of anito-cel's D-Domain Binder |
|
01/29/2026 |
News Article |
Ivonescimab Included in FirstWord Pharma's "The Drugs That Will Shape 2026" |
|
05/13/2024 |
PubMed |
Cilta-cel, a BCMA-targeting CAR-T therapy for patients with multiple myeloma. |
|
05/08/2024 |
PubMed |
Toxicity of CAR T-Cell Therapy for Multiple Myeloma. |
|
05/03/2024 |
PubMed |
An Assessment of the Effectiveness and Safety of Chimeric Antigen Receptor T-Cell Therapy in Multiple Myeloma Patients with Relapsed or Refractory Disease: A Systematic Review and Meta-Analysis. |