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:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT06660420
Brief Summary:
To find the highest tolerable dose and recommended dose of PRAME-TCR-NK cells that can be given to participants with recurrent and/or refractory melanoma. The safety and tolerability of PRAME-TCR-NK cells will also be studied.
Detailed Description:
Primary Objectives
1\. To determine he safety, tolerability, optimal cell dose (OCD), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PRAME-TCR-NK cells in participants with relapsed and/or refractory melanoma.
Secondary Objectives
1. To determine preliminary antitumor activity of PRAME-TCR-NK cells in participants with relapsed and/or relapsed and/or refractory melanoma.
2. To quantify the persistence of infused allogeneic donor PRAME-TCR-MK cells in the peripheral blood of the recipient.
3. To evaluate tissue and blood-based biomarkers associated with response and resistance to PRAME-TCR-NK cell infusion.
Study:
NCT06660420
Study Brief:
Protocol Section:
NCT06660420