Drugs / Orca-Q
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06900192 | Mar 2025 → Aug 2029 expected | primary progressive multiple sclerosis, secondary progressive multiple sclerosis | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05322850 | Aug 2022 → Sep 2026 overdue | acute lymphoblastic leukemia, acute undifferentiated leukemia, chronic myeloid leukemia, mixed phenotype acute leukemia | University of Florida | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-04-28 | Orca Biosystems, Inc. | Regulatory Orca Bio Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Orca-Q® for the Treatment of High-Risk Hematologic Malignancies orcabio.com ↗
As this is our second cell therapy candidate to receive RMAT status, we have experienced firsthand how this program can support accelerated development and enhanced communication with the FDA. |
| 2026-02-05 | Orca Biosystems, Inc. | Results Orca Bio Presents New Data at the 2026 Tandem Meetings of ASTCT® and CIBMTR® Reinforcing Orca-T® as a Durable, High-Precision Cell Therapy for Hematological Malignancies orcabio.com ↗
All patients engrafted by Day +19 (median 11 days) and demonstrated encouraging rates of OS at one, two and three years (80%, 77% and 77%, respectively). |
| 2025-12-08 | Orca Biosystems, Inc. | Results Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 67th American Society of Hematology Annual Meeting orcabio.com ↗
New data evaluating Orca-Q with and without the use of pharmacological graft versus host disease (GvHD) prophylaxis showed encouraging outcomes including rapid neutrophil recovery and low rates of acute and chronic GvHD, relapse and non-relapse mortality (NRM). |
| 2024-12-07 | Orca Biosystems, Inc. | Results Orca Bio Presents Clinical Results on Use of Orca-Q without GvHD Prophylaxis in Patients with Hematological Malignancies at the 66th ASH Annual Meeting orcabio.com ↗
There were no cases of non-relapse mortality (NRM) reported across all 14 patients. |
| 2023-12-09 | Orca Biosystems, Inc. | Results Orca Bio Presents Positive Data Demonstrating the Potential for Orca-T and Orca-Q to Expand Treatment to Additional Patient Groups at the 65th ASH Annual Meeting orcabio.com ↗
Orca-Q, Orca Bio’s second investigational high-precision cell therapy, showed encouraging data in graft-versus-host-disease-free and relapse-free survival in patients with a haploidentical donor without the use of post-transplant cyclophosphamide |
| 2023-02-16 | Orca Biosystems, Inc. | Results Orca Bio Presents Positive Data Reinforcing Clinical Profile of Orca-T and Orca-Q at 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR orcabio.com ↗
Orca-Q showed improved graft-versus-host disease-free, relapse-free survival in patients with haploidentical donors |
| 2022-12-12 | Orca Biosystems, Inc. | Results Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th ASH Annual Meeting orcabio.com ↗
Interim multi-center Phase 1 clinical trial results show that Orca-Q improved graft-versus-host disease-free, relapse-free survival in haploidentical alloHSCT compared to standard of care, without the use of post-transplant cyclophosphamide |
| 2022-11-03 | Orca Biosystems, Inc. | Results Orca Bio to Present Four Abstracts at the 64th American Society of Hematology Annual Meeting, Including Updated Relapse-Free Survival Data with Orca-T and the First Clinical Data for Orca-Q orcabio.com ↗
Additionally, results from Orca Bio’s Phase 1 clinical trial of its second investigational cell therapy, Orca-Q, in patients with haploidentical donors will be presented for the first time in an oral presentation. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Orca-Q | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06900192 ↗ |
| Modality | Cell therapy | “engineered donor graft” NCT05322850 ↗ |
| Route | Intravenous | “intravenously following myeloablative conditioning” NCT05322850 ↗ |