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SGN-CD19A · 2 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| SGN-CD19A | EXPERIMENTAL | SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg |
| Name | Type | Description |
|---|---|---|
| SGN-CD19A | DRUG | SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg |
Inclusion Criteria: * Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-posi...
SGN-CD19A is an investigational small molecule being developed for Burkitt Lymphoma, a type of cancer. It is also being studied in other B-cell malignancies including precursor B-cell lymphoblastic leukemia-lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, and mantle-cell lymphoma. The drug is currently in Phase 1 clinical development.
SGN-CD19A is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical trials to evaluate the safety of this investigational drug in patients with certain types of leukemia and lymphoma.
SGN-CD19A is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 156 participants. The drug is investigational and has not been approved by regulatory authorities. It remains in early-stage clinical testing to assess its safety profile.
SGN-CD19A has been studied in two completed Phase 1 trials. NCT01786096 enrolled 92 participants with Burkitt lymphoma and precursor B-cell lymphoblastic leukemia-lymphoma. NCT01786135 enrolled 64 participants with various B-cell lymphomas including Burkitt, follicular, diffuse large B-cell, and mantle-cell lymphoma. Both trials were conducted in the United States.
SGN-CD19A is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials, but it has not received marketing approval from the U.S. Food and Drug Administration or any other regulatory agency. The drug remains in clinical development and its safety and efficacy have not been fully established.