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CAR T-cell Therapy

ORCA-T + (tacrolimus and ruxolitinib) for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Research Sponsored by Lori Muffly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined in Section 6.1.3; with or without the presence of known minimal residual disease, or * Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT and/or treatment-related MDS \<10% blasts
2. Age ≥ 18 and ≤ 70 years at the time of enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Summary

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

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects were not detailed, but generally, treatments like ORCA-T could cause immune reactions, infection risk increase, or complications related to bone marrow transplant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Patients Without Severe Transplant-Related Adverse Events at Day +100

Trial Design

1Treatment groups
Experimental Treatment
Group I: ORCA-T + (tacrolimus and ruxolitinib)Experimental Treatment1 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).

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Who is running the clinical trial?

Orca Biosystems, Inc.Industry Sponsor
6 Previous Clinical Trials
713 Total Patients Enrolled
Lori MufflyLead Sponsor
~16 spots leftby May 2026
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