Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRGN-3006 T Cells · 1 trial · 2 indications
Incidence of dose limiting toxicity (DLT) as defined in the protocol
Systemic toxicity in general and hematologic toxicity in specific will be assessed through the capture of TEAEs at each study visit and through laboratory assessments throughout the study. The severity of the TEAEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 scale.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation and Dose Expansion of PRGN-3006 | EXPERIMENTAL | Participants will be treated in dose expansion phase to evaluate the safety and efficacy of the identified dose of PRGN-3006. |
| Name | Type | Description |
|---|---|---|
| PRGN-3006 T Cells | DRUG | Participants will receive up to 2 intravenous (IV) administrations of PRGN-3006 T Cells with or without lymphodepletion and will be monitored for safety, efficacy, and correlative endpoints for up to 12 months following infusion. |
Inclusion Criteria: * Participants must be diagnosed with either relapsed or refractory AML (including extramedullary disease), MRD-positive AML, or higher risk MDS. * Absolute lymphocyte count ≥ 0.2 k/μL. * Karnofsky performance status score ≥60%. * Life expectancy ≥ 12 weeks from the time of enro...
PRGN-3006 T Cells is an investigational adoptive cellular therapy being developed for the treatment of acute myeloid leukemia (AML). It is also being studied in patients with CD33-positive relapsed or refractory AML, minimal residual disease (MRD) positive AML, and higher-risk myelodysplastic syndromes (MDS). The drug is currently in Phase 1 clinical development.
PRGN-3006 T Cells is being developed by Precigen, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PGEN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational cell therapy in patients with certain blood cancers.
PRGN-3006 T Cells is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is actively enrolling patients, though recruitment is currently not active, meaning the study is still ongoing but not enrolling new participants.
PRGN-3006 T Cells is being evaluated in a Phase 1 clinical trial with the identifier NCT03927261. The trial is titled 'PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS' and is being conducted in the United States. The study is active but not recruiting participants.
Yes, PRGN-3006 T Cells is the same as PRGN-3006. The full name includes 'T Cells' to describe the cell therapy modality, but both names refer to the same investigational drug being developed by Precigen, Inc. for the treatment of acute myeloid leukemia and related conditions.