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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
View on ClinicalTrials.gov →
NCT06514794
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
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, 33612
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Jeremy Rubinstein, MDjeremy.rubinstein@cchmc.org
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Actively Recruiting
PhasePhase 2
SponsorWugen, Inc.
Started2025-01-31
Est. completion2026-12-30
Eligibility
Age1 Year+
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →
NCT06514794