Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03927261 | PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS | PHASE1 | ACTIVE NOT_RECRUITING | 88 | — | — | May 20, 2019 | Aug 1, 2025 | Nov 8, 2024 | 2 | United States |
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...