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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01731951` - Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis	Phase 2
Recruiting	`NCT02958397` - A Clinical Research of CD33-Targeted CAR-T in Myeloid Malignancies	Phase 1/Phase 2
Recruiting	`NCT02958384` - A Clinical Research of LeY-Targeted CAR-T in Myeloid Malignancies	Phase 1/Phase 2
Recruiting	`NCT05775406` - Safety and Clinical Activity of KT-253 in Adult Patients With High Grade Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphoma, Solid Tumors	Phase 1
Recruiting	`NCT05807659` - Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission Myeloid Malignancies	Phase 2
Active, not recruiting	`NCT02452697` - Ph2 NK Cell Enriched DCIs w/wo RLR9 Agonist, DUK-CPG-001 From Donors Following Allogeneic SCT	Phase 2
Completed	`NCT04778410` - Study of Magrolimab Combinations in Participants With Myeloid Malignancies	Phase 2
Terminated	`NCT01366612` - PRO#1278: Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation	Phase 3
Completed	`NCT03270748` - Post Transplant High-Dose Cy as GvHD Prophylaxis in 1 HLA Mismatched Unrelated HSCT for Myeloid Malignancies	Phase 2
Recruiting	`NCT05115630` - Off-the-shelf NK Cells + SCT for Myeloid Malignancies	Phase 1/Phase 2
Recruiting	`NCT05796570` - A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies	Phase 2