USO 25190
Isang Pag-aaral sa Phase 2 ng WU-CART-007, isang Anti-CD7 Allogeneic CAR-T Cell Therapy, sa mga Pasyenteng may Relapsed o Refractory T Cell Acute Lymphoblastic Leukemia at Lymphoblastic Lymphoma (T-RRex)
Mga Uri ng Sakit: CAR-T
Mga Kinakailangan sa Kwalipikasyon:
• Subjects must have evidence of T-ALL or T-LBL, as defined by WHO
classification, and either R/R or MRD+
• R/R Cohort: Disease defined by ≥5% bone marrow lymphoblasts for
evidence of EMD. Patients must meet at least one of the following:
• Primary refractory: failure to achieve remission after initial
induction including consolidation where indicated
• Relapsed disease after achieving first or any subsequent
remission.
• R/R disease after allogeneic transplant, and meet the protocolspecified criteria
• MRD Cohort: Subjects with MRD ≥0.1% and <5% bone marrow
blasts by central flow cytometry. MRD positivity is defined as failure
to achieve MRD-negative status after CR1 or CR2.
• Subjects that received prior treatment with any anti-CD7 therapy are
excluded.
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