A Single-Arm, Open-Label, Multi-Center, Phase 1b/ 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)

Study Summary

The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed/refractory T-ALL/LBL patients. Participants with relapsed/refractory T-ALL/LBL over the age of 12 will be eligible to participate. Participants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL. Patients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.

Interventions

Study Locations

Facility	City	State	Country
Stanford University	Palo Alto	California	United States
Colorado Blood Cancer Institute	Denver	Colorado	United States
University of Chicago	Chicago	Illinois	United States
Mayo Clinic - Rochester	Rochester	Minnesota	United States
Memorial Sloan Kettering Cancer Center	New York	New York	United States
Montefiore Einstein Comprehensive Cancer Center	The Bronx	New York	United States
Sarah Cannon Research Insitute	Nashville	Tennessee	United States
MD Anderson Cancer Center	Houston	Texas	United States

Official Trial Information

View on ClinicalTrials.gov