Trials / Recruiting
RecruitingNCT03802695
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Orca Biosystems, Inc. · Industry
- Sex
- All
- Age
- 12 Years – 78 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Mixed Phenotype Acute Leukemia
- Acute Lymphoblastic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OrcaGraft (Orca-Q) | engineered donor allograft |
Timeline
- Start date
- 2019-04-08
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2019-01-14
- Last updated
- 2026-02-23
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03802695. Inclusion in this directory is not an endorsement.