This Phase 2 study (T-RRex) tests WU-CART-007, an anti-CD7 allogeneic (donor-derived) CAR T-cell therapy, in patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL). It aims to evaluate the efficacy of WU-CART-007 and its ability to induce a complete response with negative minimal residual disease (MRD). Participants must have relapsed/refractory or MRD-positive T-ALL or T-LBL per WHO classification, be at least 6 months old, and have adequate organ function.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.