Engineered Donor Grafts (Orca-T) for Blood Cancers

Recruiting at 21 trial locations

Overseen By James S McClellan, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Orca Biosystems, Inc.

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: Unknown

Duration: 4 weeks

255 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

Eligibility Criteria

This trial is for adults with certain blood cancers like acute leukemia or myelodysplastic syndrome who need a stem cell transplant. They must be relatively healthy, with good liver, kidney, heart and lung function, not have other active cancers or serious infections, and can't be pregnant or breastfeeding. Participants should match an 8/8 HLA donor and cannot have had a previous transplant.

Inclusion Criteria

I am 18-65 with a certain type of leukemia and plan to have a stem cell transplant.

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

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

Exclusion Criteria

Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody

I have had a stem cell transplant from a donor.

I currently have an infection that isn't getting better with treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an allogeneic hematopoietic cell transplant with the Orca-T product

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of aGVHD and graft failure

52 weeks

Monthly visits (in-person)

Long-term follow-up

Participants are monitored for long-term outcomes such as overall survival and chronic GvHD

1 year

Treatment Details

Interventions

• Orca-T

Trial Overview The study tests 'Orca-T', an engineered donor graft designed to improve outcomes in patients receiving bone marrow transplants for various hematologic malignancies. It aims to see if this new method is safe and works well compared to traditional approaches.

Participant Groups

Group I: Subjects with Acute Leukemia or Myelodysplastic Syndrome, or BPDCN Experimental Treatment 1 Intervention

This is a non-randomized, single-arm study. All enrolled subjects will receive an allogeneic HCT with the Orca-T product.

Orca-T is already approved in United States for the following indications:

Approved in United States as Orca-T for:

• Acute Lymphoblastic Leukemia (ALL)
• Acute Myeloid Leukemia (AML)
• Myelodysplastic Syndrome (MDS)
• Myelofibrosis

Who Is Running the Clinical Trial?

Orca Biosystems, Inc.

Lead Sponsor

Trials

8

Recruited

750+