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Also known as PRGN-3006 T Cells
PRGN-3006 · 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 is an investigational cell therapy being developed for acute myeloid leukemia and related blood cancers. It is also known as PRGN-3006 T Cells. The therapy is designed to target CD33, a marker found on leukemia cells, and it is being studied in patients with relapsed or refractory disease.
PRGN-3006 is being studied in adults with CD33-positive relapsed or refractory acute myeloid leukemia, minimal residual disease positive AML, and higher risk myelodysplastic syndromes. It is an investigational therapy and has not been approved for commercial use. The Phase 1 study enrolls patients aged 18 and older.
PRGN-3006 targets CD33, a surface protein expressed on myeloid leukemia cells. It is a CAR-based adoptive cellular therapy, meaning the patient's T cells are engineered to recognize CD33. The trial enrolls patients whose disease is CD33-positive, so the target is used to select eligible participants.
PRGN-3006 is being developed by Precigen, Inc., which trades on the Nasdaq under the ticker PGEN. Precigen is the sponsor of the clinical program evaluating the therapy in acute myeloid leukemia and myelodysplastic syndromes. The company is conducting the work in the United States.
PRGN-3006 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 study is currently active but not recruiting, and no trials of the therapy have been completed to date.
PRGN-3006 is being evaluated in one clinical trial, NCT03927261, titled PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS. The Phase 1 study has an enrollment of 88 participants, is active but not recruiting, and is conducted in the United States.