OrcaGraft for Blood Cancer

Recruiting at 6 trial locations

Overseen By Tamara Zharkevich, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Orca Biosystems, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Prior HCT, HIV, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 365

Duration: 4 weeks

186 Participants Needed

What You Need to Know Before You Apply

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).

Who Is on the Research Team?

James S McClellan, MD, PhD

Principal Investigator

Orca Biosystems, Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• OrcaGraft (Orca-Q)

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.

How Is the Trial Designed?

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

OrcaGraft (Orca-Q) is already approved in United States for the following indications:

Approved in United States as Orca-Q for:

• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Myelodysplastic Syndromes
• Chronic Myeloid Leukemia
• Primary Myelofibrosis

Who Is Running the Clinical Trial?

Orca Biosystems, Inc.

Lead Sponsor

Trials

8

Recruited

750+