Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PTOC1 · 1 trial · 1 indication
Types, frequency and severity of adverse events.
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ranges from 0 to 105 points. The higher the score, the higher the disease activity.
Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scores. "0" indicates no disease activity and "3" indicates the most severe disease activity.
British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is graded as A, B, C and D. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is uninvolved.
The definition of SRI-4 response: SLEDAI-2K ≥ 4 points improvement; PGA \<0.3 points increase; BILAG 2004 with no new A grade score and no more than 1 new B grade score.
The definition of LLDAS: SLEDAI-2K ≤ 4 points and no disease activity in major organs (kidney, central nervous system, heart and lung), and no vasculitis or fever; no new disease activity symptoms compared with previous disease assessments; PGA ≤ 1; serological parameters not required; with the permitted use of low-dose glucocorticoids (prednisolone ≤ 7.5 mg/day), and/or stable immunosuppressives and biologics.
The definition of DORIS: SLEDAI-2K = 0 points; PGA \< 0.5 points; serological parameters not required; with the permitted use of antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
| Arm | Type | Description |
|---|---|---|
| PTOC1 | EXPERIMENTAL | This trial was designed as an open, single-arm, single-center, dose-exploration trial. |
| Name | Type | Description |
|---|---|---|
| PTOC1 | BIOLOGICAL | Three dose groups (1.5×10\^5/kg, 5×10\^5/kg,1×10\^6/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose. |
Inclusion Criteria: * Age ≥ 5 years, no gender limitation; * Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria, and still in moderate to severe disease activity despite ≥ 3 months of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steroid),...
Top 20 of 32 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Biogen Inc. | BIIB | 5 | PHASE3 | Litifilimab |
| Bristol-Myers Squibb Company | BMY | 7 | PHASE3 | Deucravacitinib |
| Viatris, Inc. | VTRS | 5 | PHASE3 | Cenerimod |
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Ianalumab |
| AstraZeneca PLC | AZN | 21 | PHASE3 | Medi-546 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Belimumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | SAR441344 |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE2 | Obexelimab |
| Alumis Inc. | ALMS | 1 | PHASE2 | Envudeucitinib |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| 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, Fludarabine, Cyclophosphamide |
| Artiva Biotherapeutics, Inc. | ARTV | 2 | PHASE1 | AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
PTOC1 is an investigational monoclonal antibody being developed for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
PTOC1 is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DTIL. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.
PTOC1 is currently in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing Phase 1 trial is actively recruiting participants to evaluate the therapy in patients with Systemic Lupus Erythematosus.
PTOC1 is being evaluated in a Phase 1 clinical trial registered as NCT07403097, titled 'Study of CD19 CAR-T Therapy for Refractory SLE'. This single-arm, open-label study is recruiting 18 participants with Systemic Lupus Erythematosus in China and is not yet completed.
PTOC1 is a monoclonal antibody, while the clinical trial NCT07403097 evaluates CD19 CAR-T therapy. The trial title references CD19 CAR-T, but PTOC1 itself is classified as a monoclonal antibody, indicating a different mechanism of action from CAR-T cell therapy.