Allogeneic ORCA-Q Stem Cell Transplant for the Treatment of Relapsed and Refractory High Risk Multiple Myeloma

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07759102
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Allogeneic Defined Hematopoietic Stem Cells/Immune Cells — BIOLOGICAL
    Given Orca-Q prime IV
  • Allogeneic Defined Hematopoietic Stem Cells/Immune Cells — BIOLOGICAL
    Given Orca-Q supplement IV
  • Busulfan — DRUG
    Given IV
  • Filgrastim — BIOLOGICAL
    Given SC
  • Fludarabine — DRUG
    Given IV
  • Granulocyte Colony-Stimulating Factor — DRUG
    Given SC
  • Thiotepa — DRUG
    Given IV

Study Details

This phase I trial tests the effect of allogeneic Orca-Q stem cell transplant in treating patients with high-risk multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). An allogeneic (donor) transplant uses blood forming stem cells (graft) from a matched donor. When the healthy blood forming (stem) cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease \[GVHD\]). Orca-Q includes some T cells (a type a white blood cell) that are thought to help prevent some of the known complications as well as help attack the cancer cells. However, Orca-Q removes a specific type of T cell called naive T lymphocytes. Naive T cells may contribute to GVHD and are not thought to be required for the success of the treatment. Removing these cells may help reduce the frequency or severity of GVHD. Giving chemotherapy, such as thiotepa, busulfan, and fludarabine, before a donor stem cell transplant helps kill cancer cells in the body and prepare the body to receive the transplant graft. Giving allogeneic Orca-Q may be safe, tolerable, and/or effective in treating patients with relapsed or refractory (R/R) high-risk multiple myeloma.

Key Dates

First listed
Aug 12, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2032
Completion
Sep 1, 2033

Study Design

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

Arms

  • Experimental: Treatment (Orca-Q, thiotepa, busulfan, fludarabine)
    Recipient participants receive thiotepa IV over 3 hours on days -7 and -6, busulfan IV over 3 hours on days -5 to -3, fludarabine IV over 30 minutes on days -5 to -2, Orca-Q prime IV on day 0, followed by Orca-Q supplement IV on day 0 or 1 in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of primary graft failure without grade II-IV acute graft-versus-host disease (GVHD) [ Time Frame: From date of transplant and up to 30 days post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Office of Clinical Research
[email protected]
916-382-6970
Mehrdad Abedi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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