Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies
Summary
This study is a Phase 1, non-randomized, open-label/Phase 2 randomized, blinded study of ProTmune (ex vivo programmed mobilized peripheral blood cells) versus non-programmed mobilized peripheral blood cells for allogeneic hematopoietic cell transplantation (HCT) in adult subjects aged 18 years and older with hematologic malignancies. A total of 88 study subjects were treated in the trial at approximately 15 centers in the US.
Timeline
- Start
- 2016-12-20
- Primary completion
- 2020-12-04
- Completion
- 2021-11-05
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
release “All Subjects in PROTECT Phase 1 Study of ProTmune Achieve Day 100 Relapse-free Survival” reads as met primary endpoint fatetherapeutics.com ↗
release “no events of cancer relapse have occurred with ProTmune in the Phase 1 stage of PROTECT” reads as met primary endpoint fatetherapeutics.com ↗
release “the PROTECT study of ProTmune did not meet its primary endpoint for prevention of acute graft-versus-host disease” reads as missed primary endpoint fatetherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ProTmune | Cell therapy | — | — |