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Study of Cord Blood-derived NK Cells for Relapsed/Refractory Myeloma

This study is testing a new treatment for multiple myeloma (a type of blood cancer) that has come back or not responded to previous treatments. The treatment uses special immune cells called Natural Killer (NK) cells, which come from umbilical cord blood. These NK cells are modified to target a specific protein called NY-ESO-1, which is found on some myeloma cells. You would first receive two chemotherapy drugs, Fludarabine phosphate and Cyclophosphamide, followed by the modified NK cells. To join, your myeloma cells must show the NY-ESO-1 protein. The study aims to find the safest and most effective dose of these NK cells and see how well they control the disease. We are looking for 44 participants aged 18 to 80.

Study design
This is an interventional study with a planned enrollment of 44 participants. It is structured in two parts: Part A to find the best dose and Part B to assess the treatment's effectiveness at that dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess your response to treatment at 30 days and your progression-free survival at 180 days after the NK cell infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06066359

Ph I/II Trial of Cord Blood-derived NK Cells With NY-ESO-1 TCR/IL-15 for R/R Myeloma

Recruiting
PHASE1Ages 18–80InterventionalTreatment
M.D. Anderson Cancer Center
~44 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Fludarabine phosphateCyclophosphamideAllogeneic Anti-NY-ESO-1-TCR-IL-15-transduced Cord Blood-derived Natural Killer Cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (Part A)
Measured over Within 28 days of the natural killer (NK) cell infusion
+1 more outcome measured

Conditions

Relapsed/Refractory Myeloma

Explore related trials

Multiple MyelomaPlasma Cell LeukemiaHLA-A Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Muzaffar Qazilbash, M D · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Muzaffar Qazilbash, M D
[email protected]
(713) 745-3458
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Eligibility criteria

Inclusion

Note: Growth factor support is allowed prior to lymphodepletion chemotherapy (LD chemo). Transfusion support is allowed at any time. If cytopenias are related to multiple myeloma, the patient may proceed without meeting above hematologic parameters only if bone marrow plasma cells are \>= 50% 19. Hemoglobin ≥ 8 g/dL
Note: Growth factor support is allowed prior to LD chemo. Transfusion support is allowed at any time. If cytopenias are related to multiple myeloma, the patient may proceed without meeting above hematologic parameters only if bone marrow plasma cells are \>= 50% 20. Platelet count \>= 25,000 /uL
Note: Growth factor support is allowed prior to LD chemo. Transfusion support is allowed at any time. If cytopenias are related to multiple myeloma, the patient may proceed without meeting above hematologic parameters only if bone marrow plasma cells are \>= 50% 21. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. The study team will ask for information about the pregnancy 22. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor 23. Signed consent to long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies 24. Patients with relapsed or refractory plasma cell leukemia who have received at least two previous regimens

What this trial measures

  • Incidence of dose-limiting toxicities (Part A)Within 28 days of the natural killer (NK) cell infusion

    Characterized by stringent complete response + complete response + very good partial response + partial response. Will provide an estimate of the objective response rate along with a 95% exact confidence interval.

  • Overall response rate (Part B)At day 30 following NK cell infusion

    Characterized by stringent complete response + complete response + very good partial response + partial response. Will provide an estimate of the objective response rate along with a 95% exact confidence interval.