Spots Global Cancer Trial Database for Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies

Official Title: Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies

Study ID: NCT06383572

Conditions

Lymphodepleting Chemotherapy

Myeloid Malignancies

Interventions

Cyclophosphamide

Fludarabine phosphate

Decitabine

Study Description

Brief Summary: To find a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS.

Detailed Description: Primary Objectives To assess dose-limiting toxicity (DLT) and determine the safety, day 30 response rate, day 180 treatment failure rate (defined as disease progression or death) and optimal cell dose of T cell receptor (TCR) modified cord blood-natural killer (CB-NK) cells (TCR-NK) targeting PRAME in patients with relapsed/refractory myeloid malignances, for each of the following diseases; AML, MDS, and Multiple Myeloma. The day 30 response rate and day 180 treatment failure rate will be estimated, and the estimates will be used to identify an optimal dose of PRAME-TCR-NK cells. Secondary Objectives * To assess the preliminary efficacy of PRAME-TCR-NK cells (Day+ 30 complete and partial response rates; Day 180 progression-free survival rate) in patients with relapsed/refractory AML, MDS, and Multiple Myeloma. * To quantify persistence of infused allogeneic donor PRAME-TCR CB-derived NK cells in the recipient as an integrated evaluation * To conduct comprehensive immune reconstitution studies. 2.2.4 To obtain preliminary data on quality of life and patient experience (PROMIS-29 quality of life questionnaire score)