Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SC291 · 2 trials · 8 indications
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
| Arm | Type | Description |
|---|---|---|
| LN Cohort | EXPERIMENTAL | SC291 with lymphodepleting therapy |
| ERL Cohort | EXPERIMENTAL | SC291 with lymphodepleting therapy |
| AAV Cohort | EXPERIMENTAL | SC291 with lymphodepleting therapy |
| SC291 Plus Chemotherapy Regimen | EXPERIMENTAL | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291 |
| Name | Type | Description |
|---|---|---|
| SC291 | BIOLOGICAL | SC291 is an allogeneic CAR T cell therapy |
Inclusion Criteria: 1. Age ≥18 and ≤75 2. For LN cohort: * Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) * Biopsy-proven LN class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology So...
Top 20 of 31 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Biogen Inc. | BIIB | 5 | PHASE3 | Litifilimab |
| Bristol-Myers Squibb Company | BMY | 7 | PHASE3 | Deucravacitinib, Afimetoran, Zolacabtagene autoleucel |
| Viatris, Inc. | VTRS | 5 | PHASE3 | cenerimod |
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Ianalumab, Rapcabtagene autoleucel, PIT565 |
| AstraZeneca PLC | AZN | 21 | PHASE3 | Medi-546, Anifrolumab, AZD0120, AZD5492, Surovatamig |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib, ABBV-319 |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Belimumab, GSK4527363, GSK5926371 |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Frexalimab, SAR448501 |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE2 | Obexelimab |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Alumis Inc. | ALMS | 1 | PHASE2 | Envudeucitinib |
| Amgen Inc. | AMGN | 1 | PHASE2 | Inebilizumab, Blinatumomab |
| Fate Therapeutics, Inc. | FATE | 2 | PHASE2 | FT819 |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY4298445 |
| Cartesian Therapeutics, Inc. | RNAC | 2 | PHASE2 | Descartes-08 |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-1045 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE1 | KITE-363 |
| Artiva Biotherapeutics, Inc. | ARTV | 2 | PHASE1 | AB-101 |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX112 |
SC291 is an investigational CD19-targeted monoclonal antibody being studied for lupus erythematosus, including systemic lupus erythematosus, and for B-cell malignancies such as non Hodgkin lymphoma and chronic lymphocytic leukemia. It is in Phase 1 clinical development and has not been approved by the FDA.
SC291 targets CD19, a protein found on B cells. By binding to CD19, the monoclonal antibody is designed to deplete or modulate B cells involved in autoimmune diseases like lupus and in B-cell malignancies. This mechanism is being evaluated in early-stage clinical trials.
SC291 is being developed by Sana Biotechnology, Inc., a biopharmaceutical company traded on NASDAQ under the ticker SANA. The company is conducting Phase 1 clinical trials to evaluate the safety and efficacy of SC291 in patients with autoimmune diseases and B-cell malignancies.
SC291 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA for any use. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review of therapies for serious conditions.
SC291 is being evaluated in two Phase 1 trials. NCT06294236, known as GLEAM, is studying SC291 in severe relapsed or refractory B-cell mediated autoimmune diseases, including lupus, with 7 participants. NCT05878184, known as ARDENT, is studying SC291 in relapsed or refractory B-cell malignancies, including non Hodgkin lymphoma, with 16 participants.
SC291 is a distinct investigational monoclonal antibody developed by Sana Biotechnology. No alternative names for SC291 have been disclosed in the clinical trial records. It is being studied under the trial names GLEAM and ARDENT, which refer to the specific clinical studies, not to the drug itself.