A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)

NCT06514794 · tracked via the Priya Life Science USA tracker

Sponsor

Allotera Therapeutics

Phase

Phase 2

Started

2025-01-31

Last updated

2026-09-03

Condition(s) studied

T-cell Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma

Investigational drug(s) / intervention(s)

WU-CART-007

WU-CART-007: A single IV infusion of WU-CART-007

Study summary

The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response

Eligibility

Sex

ALL

Min age

6 Months

Max age

—

Healthy volunteers

Key Inclusion Criteria: * Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive * Age: Lower age limit of ≥ 6 months; adequate organ function * Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening. Key Exclusion Criteria: * Prior treatment with any anti-CD7 therapy. * Patients with decompensated hemolytic anemia. * Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.

Primary outcome measure(s)

R/R Cohort - Composite Complete Response Rate — 24 months
CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)
MRD Pos Cohort - Response Rate — 24 months
Defined as the efficacy of WU-CART-007 to induce complete MRD negative response

Trial sites (18)

Facility	City	Region	Status
City of Hope	Duarte	California	Recruiting
Children's Hospital Los Angeles	Los Angeles	California	Recruiting
Colorado Blood Cancer Institute	Denver	Colorado	Recruiting
Children's National Hospital	Washington D.C.	District of Columbia	Recruiting
H. Lee Moffitt Cancer Center and Research Institute Hospital	Tampa	Florida	Recruiting
Children's Hospital of Atlanta	Atlanta	Georgia	Recruiting
Washington University Saint Louis	St Louis	Missouri	Recruiting
Memorial Sloan Kettering Cancer Center -- Pediatrics	New York	New York	Recruiting
Oncology Hematology Care	Cincinnati	Ohio	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	Recruiting
TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy	Nashville	Tennessee	Recruiting
MD Anderson Cancer Center	Houston	Texas	Recruiting
Sarah Cannon Transplant and Cellular Therapy Methodist Hospital	San Antonio	Texas	Recruiting
Sarah Cannon, Virginia Oncology Associates	Norfolk	Virginia	Recruiting
Seattle Children's Hospital	Seattle	Washington	Recruiting
Peter Mac Callum Cancer Institute	Melbourne	Victoria	Recruiting
Royal Children's Melbourne	Melbourne	Victoria	Recruiting

More Allotera Therapeutics trials in the USA

A Phase 1b Study of WU-NK-101 in Combination With Cetuximab Active, not recruiting

A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007 Enrolling by invitation

Other trials for the same condition

A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL) Active, not recruiting

First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect. Recruiting

A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007 Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06514794 on ClinicalTrials.gov ↗ ← All trials in the USA