OrcaGraft for Blood Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Orca Biosystems, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Prior HCT, HIV, Autoimmune, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and effectiveness of using specially prepared donor cells for patients with blood cancers. These patients are receiving a strong type of bone marrow transplant. The goal is to replace their damaged bone marrow with healthy cells from a donor to help them recover. Bone marrow transplantation (BMT) is a powerful strategy for the treatment of leukemia, aplastic anemia, congenital immunodeficiency, and autoimmune diseases.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot be on corticosteroids or other immunosuppressive therapy, except for low-dose topical or oral corticosteroids (10 mg/day or less).

Research Team

James S McClellan, MD, PhD

Principal Investigator

Orca Biosystems, Inc.

Eligibility Criteria

This trial is for adults aged 18-65 with certain blood cancers like acute leukemia or high-risk myelodysplastic syndrome. Participants must match with a donor, have good kidney and heart function, and not be pregnant or on strong immunosuppressants. Those with uncontrolled infections, other active cancers, prior transplants, or severe comorbidities cannot join.

Inclusion Criteria

Estimated glomerular filtration rate (eGFR) > 50 mL/minute

I am scheduled for a stem cell transplant from a donor.

Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)

Exclusion Criteria

I need assistance with my daily activities.

Seropositive for HIV-1 or -2, HTLV-1 or -2

I am not pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Orca-Q engineered donor grafts as part of myeloablative allogeneic hematopoietic cell transplantation

4 weeks

Multiple visits for transplantation and monitoring

Follow-up

Participants are monitored for safety, efficacy, and engraftment outcomes, including neutrophil and platelet engraftment

52 weeks

Regular visits for monitoring up to 365 days post-transplant

Treatment Details

Interventions

• OrcaGraft (Orca-Q) (CAR T-cell Therapy)

Trial Overview The study tests 'OrcaGraft' (Orca-Q), an engineered donor graft in patients receiving bone marrow transplants for blood cancers. It aims to assess the safety and effectiveness of this new treatment approach during the transplant process.

Participant Groups

Group I: Arm C Experimental Treatment 1 Intervention

Recipients with an HLA-identical related or unrelated donor; no GVHD prophylaxis given

Group II: Arm B Experimental Treatment 1 Intervention

Recipients with haploidentical-related donors; with single-agent GVHD prophylaxis given

Group III: Arm A Experimental Treatment 1 Intervention

Recipients with HLA-identical or 1-allele mismatched (7/8 alleles) related or unrelated donor; with single-agent GVHD prophylaxis given

Who Is Running the Clinical Trial?

Orca Biosystems, Inc.

Lead Sponsor

Trials

8

Recruited

750+