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

Summary

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.

Conditions

• Recurrent Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

BIOLOGICAL

Allogeneic Defined Hematopoietic Stem Cells/Immune Cells

Given Orca-Q prime IV

BIOLOGICAL

Allogeneic Defined Hematopoietic Stem Cells/Immune Cells

Given Orca-Q supplement IV

DRUG

Busulfan

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine

Given IV

DRUG

Granulocyte Colony-Stimulating Factor

Given SC

DRUG

Thiotepa

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Orca Biosystems, Inc.

  collaborator INDUSTRY

• University of California, Davis

  lead OTHER

Principal Investigators

• Mehrdad Abedi · University of California, Davis

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2032-09-01

Completion

2033-09-01

FDA Drug

Yes

Countries

• United States

Study Locations