ORCA-T for Blood Cancers

Overseen By Alyssa Kanegai

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Lori Muffly

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Prior allogeneic HCT, Uncontrolled infections, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 3-4 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking corticosteroids or other immunosuppressive therapy, except for topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day. If you have been exposed to a T cell-depleting agent, a washout period (time without taking certain medications) of 5 half-lives is required before the trial.

What is the purpose of this trial?

The study goal is to characterize the safety of the combination of Orca-T with dual agent GVHD prophylaxis.

Eligibility Criteria

This trial is for patients with advanced blood cancers like various types of leukemia and myelodysplastic syndrome, who are planning to undergo allogeneic hematopoietic cell transplantation (HCT). Specific eligibility criteria details were not provided.

Inclusion Criteria

My kidney function is normal or only mildly reduced.

Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27%

Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 50%

Exclusion Criteria

I do not have any ongoing serious infections.

Documented allergy or hypersensitivity to specific proteins

I have had heart problems within a specific time frame.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Orca-T with dual agent GVHD prophylaxis, including tacrolimus and ruxolitinib

Approximately 3-4 weeks

Multiple visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on transplant-related adverse events

18 months

Regular follow-up visits

Treatment Details

Interventions

• ORCA-T

Trial Overview The trial is testing the safety of a new treatment called ORCA-T when used alongside two other drugs meant to prevent graft-versus-host disease (GVHD) after an allogeneic HCT.

Participant Groups

Group I: ORCA-T + (tacrolimus and ruxolitinib) Experimental Treatment 1 Intervention

Dual-agent tacrolimus starting on the day after Tcon infusion (Day +3 or Day +4) and ruxolitinib starting on the day after tacrolimus (Day +4 or Day +5).

Who Is Running the Clinical Trial?

Lori Muffly

Lead Sponsor

Trials

1

Recruited

20+

Orca Biosystems, Inc.

Industry Sponsor

Trials

8

Recruited

750+