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

Myeloid Malignancies Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06383572
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact	Jeremy Ramdial, MD
Phone	(713) 745-0146
Email	jlramdial@mdanderson.org
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	October 31, 2024
Completion date	April 1, 2029

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