WU-CART-007 at the RP2D demonstrated a high response rate in patients with relapsed/refractory T-ALL/LBL and has the potential to provide a new treatment option. ClinicalTrials.gov registration: NCT04984356.
Most (72%; 13) pts had G1-2 CRS events; a single G3 CRS event was reported which resolved within 72 hours after receiving tocilizumab, steroids, and low-dose vasopressors. WU-CART-007 has demonstrated an acceptable safety profile and preliminary evidence of anti-leukemic activity. This program advances CAR-T cell therapy in heavily pre-treated patients with R/R T-ALL/LBL.
Two different LDC regimens have been tested: standard LDC (fludarabine 30 mg/m2/day x 3 days and cyclophosphamide 500 mg/m2/day x 3 days), and enhanced LDC (eLDC; fludarabine 30 mg/m2/day x 4 days and cyclophosphamide 1000 mg/m2/day x 3 days)...Most (72%; 13/18) pts had G1-2 CRS events; a single G3 CRS event was reported which resolved within 72 hours after receiving tocilizumab, dexamethasone, and low-dose vasopressors...This program advances CAR-T cell therapy in heavily pre-treated patients with R/R T-ALL/LBL. Enrollment is ongoing.
All patients receive a 3-day lymphodepletion regimen consisting of fludarabine and cyclophosphamide, followed by a single dose of WU- CART-007...Most (86%; 7/8) pts had G1-2 CRS events; a single G3 CRS event was reported which resolved within 24 hours after receiving tocilizumab, dexamethasone and low dose vasopressors... WU-CART-007 has demonstrated an acceptable safety profile and preliminary evidence of anti-leukemic activity. in a subset of patients. This program advances CAR-T cell therapy in heavily pre-treated patients with R/R T-ALL/LBL.
over 1 year ago
P1/2 data • CAR T-Cell Therapy
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cyclophosphamide • dexamethasone • fludarabine IV • Actemra IV (tocilizumab) • WU CART 007
P1, N=48, Not yet recruiting, Washington University School of Medicine | Trial completion date: Sep 2025 --> Jan 2026 | Initiation date: Mar 2023 --> Jul 2023 | Trial primary completion date: Sep 2025 --> Jan 2026
over 1 year ago
Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
P1, N=48, Not yet recruiting, Washington University School of Medicine | Trial completion date: Jun 2025 --> Sep 2025 | Initiation date: Dec 2022 --> Mar 2023 | Trial primary completion date: Jun 2025 --> Sep 2025
almost 2 years ago
Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
P1, N=48, Not yet recruiting, Washington University School of Medicine | Trial completion date: Feb 2025 --> Jun 2025 | Initiation date: Aug 2022 --> Dec 2022 | Trial primary completion date: Feb 2025 --> Jun 2025
2 years ago
Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
All patients will receive a single infusion of WU-CART-007 cells on day 1 following a lymphodepleting conditioning therapy consisting of fludarabine and cyclophosphamide on days -5 to -3. Response will be assessed on Cycle 1 Day 28 (± 1 days), and at Months 3, 6, 12, and 24, by bone marrow aspirate and biopsy and PET/CT if indicated. Response will be defined as per modified NCCN Guidelines Version 2.2020.
3 years ago
Clinical • P1/2 data • CAR T-Cell Therapy • IO biomarker
Conclusions These preclinical studies support the use of WU-CART-007 in clinical trials and highlight the potential of WU-CART-007 to be a well-tolerated and active therapy for patients with CD7+ T-cell malignancies. A first in human Phase 1/2 trial in patients with R/R T-ALL/LBL is currently open for enrollment (NCT# 04984356).