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Clinical Trials in the USA / NCT06514794
Recruiting Phase 2

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
2026-09-28

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
No
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) 0 or 1/Karnofsky Performance Status 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)

FacilityCityRegionStatus
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

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 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
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