Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06551584
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ORCA-T — DRUG
    On Day 0, participants will receive an infusion of Orca-T HSPCs and Orca-T Tregs. On Day +2 or +3 (between approximately 48 to 72 hours of Day 0), patients will receive an infusion of the Orca-T Tcons. There is no dose escalation or de-escalation planned for the Orca-T investigational product.

Study Details

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

Key Dates

Start date
Dec 1, 2025
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ORCA-T + (tacrolimus and ruxolitinib)
    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).

Primary Outcome Measure

Proportion of Patients Without Severe Transplant-Related Adverse Events at Day +100 [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Alyssa Kenegai
[email protected]
650-736-1596
Lori Muffly, MD, MS (PRINCIPAL_INVESTIGATOR)

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