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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 2Sponsored by Wugen, Inc.
Actively Recruiting
PhasePhase 2
SponsorWugen, Inc.
Started2025-01-31
Est. completion2026-12-30
Eligibility
Age1 Year+
Healthy vol.Accepted
Locations8 sites

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

Age: 1 Year+Healthy volunteers accepted
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 ≥ 1 year; 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.

Conditions3

CancerLymphoblastic LymphomaT-cell Acute Lymphoblastic Leukemia

Locations8 sites

City of Hope
Duarte, California, 91010
Children's Hospital Los Angeles
Los Angeles, California, 90027
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, 33612
Washington University Saint Louis
St Louis, Missouri, 63108
Katie Strickerkstricker@wustl.edu
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Jeremy Rubinstein, MDjeremy.rubinstein@cchmc.org

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