Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Mu… (NCT06203912) | Clinical Trial Compass
CompletedPhase 1
Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma
United States3 participantsStarted 2024-03-05
Plain-language summary
This phase I trial tests the side effects and best dose of TGFbi natural killer (NK) cells (TiNK) when given together with isatuximab for the treatment of patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to treatment (refractory). NK cells are a type of white blood cell that are known to spontaneously attack cancer cells. TiNK are NK cells made in a laboratory to have a higher response to tumor cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as isatuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Patients also receive standard treatment (cyclophosphamide and dexamethasone) on this trial. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving TiNK and isatuximab with standard treatment may be a safe and effective treatment for relapsed or refractory multiple myeloma.
Who can participate
Age range
18 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:
* Patients 18 years of age or older with evidence of relapsed or refractory disease as defined by IMWG criteria and measurable disease as defined by any of the following:
* Serum M-protein ≥ 0.5 g/dl
* Urine monoclonal protein ≥ 200 mg/24h
* Involved free light chain (FLC) level ≥ 10mg/dl (≥ 100mg/l) and an abnormal serum free light chain ratio (\< 0.26, or \> 1.65)
* Patients must have had at least 3 prior lines of therapy including lenalidomide, proteasome inhibitor (PI), anti-CD38 or anti-SLAMF7 directed antibody, and BCMA-targeting therapy.
* Prior daratumumab or isatuximab is permitted but not in the immediate line prior to study entry
* Prior autologous hematopoietic cell transplant is permitted
* Prior allogeneic transplant is excluded
* Refractory (progressed on or within 60 days of treatment) to their last treatment
* If chimeric antigen receptor t cell (CAR-T) therapy was the immediately prior therapy, then the definition of refractory disease will not be limited to within 60 days
* Patients must be off last treatment for at least 2 weeks by the beginning of treatment on this protocol
* Hemoglobin ≥ 7g/dL
* Absolute neutrophil count (ANC) ≥ 1000/µL
* Platelets ≥ 70,000/µL
* If plasma cell percentage on bone marrow biopsy core is \> 30%, platelet requirement will be adjusted to 50,000/µl
* Total bilirubin \< 2 mg/dL
* Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)/ alkaline phosphatase \< 2.5 X the upper li…
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.
1This is a Phase 1 trial that has already completed enrollment and was mainly designed to measure the safety and side effects of combining donor immune cells with isatuximab — what has been reported so far about the types and severity of adverse events seen in participants?
2Since this trial uses donor immune cells from someone else, can you explain what risks that introduces for me specifically, such as graft-versus-host disease or immune reactions, and how those compare to my other treatment options right now?
3Given that this trial has completed recruitment and is no longer enrolling, are there any follow-on trials or published results I should be aware of that might open a path to this type of TGFbi NK cell therapy for me?
4My myeloma is relapsed or refractory, and this trial combined a donor cell therapy with isatuximab — how does that combination approach compare to the standard-of-care options currently available to me at this stage of my disease?
5Because this is a Phase 1 study, the main goal was safety rather than proving the treatment works — does the early data give you any sense of whether this approach showed enough promise that it might be worth pursuing through expanded access or a later-phase trial?
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 and severity of adverse events (AE)
Timeframe: Up to 60 days after completion of study treatment