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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)

RecruitingPhase 2

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

Who can join

6 Months · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Allotera Therapeutics · Participants: 125 · Started: Jan 31, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06514794

Locations in the U.S.

CaliforniaCity of Hope, Duarte
Children's Hospital Los Angeles, Los Angeles
ColoradoColorado Blood Cancer Institute, Denver
District of ColumbiaChildren's National Hospital, Washington D.C.
FloridaH. Lee Moffitt Cancer Center and Research Institute Hospital, Tampa
GeorgiaChildren's Hospital of Atlanta, Atlanta
MissouriWashington University Saint Louis, St Louis
New YorkMemorial Sloan Kettering Cancer Center -- Pediatrics, New York
OhioCincinnati Children's Hospital Medical Center, Cincinnati
Oncology Hematology Care, Cincinnati
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
TennesseeTriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy, Nashville
TexasMD Anderson Cancer Center, Houston
Sarah Cannon Transplant and Cellular Therapy Methodist Hospital, San Antonio
VirginiaSarah Cannon, Virginia Oncology Associates, Norfolk
WashingtonSeattle Children's Hospital, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.