Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma
- Conditions
- Myeloma
- Interventions
- Registration Number
- NCT06066359
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
To find the recommended dose of NY-ESO-1 TCR/IL-15 NK cells that can be given to patients with relapsed or refractory MM.
To learn if the dose of NY-ESO-1 TCR/IL-15 NK cells found in Part A can help to control the disease.
- Detailed Description
Primary Objectives:
* Part A: To assess dose-limiting toxicity (DLT) and determine the safety and optimal cell dose of NY-ESO-1 TCR/IL-15 NK cells in patients with relapsed/refractory multiple myeloma.
* Part B: To assess the day +90 overall response rate in patients treated at the optimal cell dose.
Secondary Objectives:
* Assess day +180 progression-free survival (PFS).
* Quantify the persistence of infused allogeneic donor TCR-transduced CB-derived NK cells in the recipient.
* To conduct comprehensive immune reconstitution studies.
* To obtain preliminary data on quality of life and patient experience.
* Assess duration of response (DOR)
Secondary end points
* Day +180 PFS rate;
* NY-ESO-1 TCR/IL-15 NK cell numbers in peripheral blood vs time profile;
* Characterization of lymphocyte populations at various time points;
* PROMIS-29 quality of life questionnaire score.
* Duration of response
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 44
Not provided
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part A2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT Fludarabine phosphate - Part B: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT NY-ESO-1 TCR/IL-15 NK - Part A: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT Cyclophosphamide - Part A2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT NY-ESO-1 TCR/IL-15 NK - Part B2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT NY-ESO-1 TCR/IL-15 NK - Part A: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT NY-ESO-1 TCR/IL-15 NK - Part B: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT Fludarabine phosphate - Part A: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT Fludarabine phosphate - Part A2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT Cyclophosphamide - Part B: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT Cyclophosphamide - Part B2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT Fludarabine phosphate - Part B2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT Cyclophosphamide -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 through study completion; an average of 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States