Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT06066359
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
Study:
NCT06066359
Study Brief:
Protocol Section:
NCT06066359