Allogeneic ORCA-Q Stem Cell Transplant for the Treatment of Relapsed and Refractory High Risk Mul… (NCT07759102) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Allogeneic ORCA-Q Stem Cell Transplant for the Treatment of Relapsed and Refractory High Risk Multiple Myeloma
United States20 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ability to understand and sign informed consent
* Age ≥ 18 years and ≤ 65 years
* Patients should be in very good partial response (VGPR) (5% or less plasma cells in the marrow) or better response status at the time of stem cell transplant with no evidence of central nervous system (CNS) disease. Patients in complete response (CR) should have minimal residual disease (MRD) positivity
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1; or Karnofsky performance status (KPS) of ≥ 70%
* ≥ 60 days washout period from the last dose of an anti-CD38 antibody before the allogeneic transplant
* ≥ 6 months washout period from the last autologous transplant before the allogeneic transplant
* Related or unrelated donors available as follows:
* Sibling donor who is a 7/8 mismatched or 8/8 matched for human leukocyte antigen (HLA)-A, -B, -C, -DRB1
* Matched unrelated donor who is a 7/8 mismatched or 8/8 matched for HLA-A, -B, -C, and -DRB1
* A diagnosis of relapsed or refractory defined as:
* Primary refractory disease or relapse \< 12 months following initial therapy that includes an immunomodulatory agent, proteasome inhibitor, anti-CD38 monoclonal antibody, and corticosteroid
* Relapse \< 12 months after first autologous stem cell transplant
* Failing to achieve complete response or relapsing after chimeric antigen receptor (CAR)-T treatment or bispecific antibodies; or indicated but ineligible for either bispecific antibodies or CAR-…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of primary graft failure without grade II-IV acute graft-versus-host disease (GVHD)
Timeframe: From date of transplant and up to 30 days post-transplant