^
    29d
    Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | N=54 --> 6
    Enrollment closed • Enrollment change • CAR T-Cell Therapy
    |
    CD7 (CD7 Molecule)
    |
    CD7 expression
    |
    WU CART 007
    3ms
    Anti-CD7 allogeneic WU-CART-007 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma: a phase 1/2 trial. (PubMed, Res Sq)
    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.
    P1/2 data • Journal
    |
    CD7 (CD7 Molecule)
    |
    WU CART 007
    3ms
    WU-CART-007 1001: A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL (clinicaltrials.gov)
    P1/2, N=29, Completed, Wugen, Inc. | Active, not recruiting --> Completed | N=44 --> 29 | Trial completion date: Aug 2026 --> Jun 2024 | Trial primary completion date: May 2026 --> Jun 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    WU CART 007
    4ms
    A Phase 2 Study WU-CART-007 in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (clinicaltrials.gov)
    P2, N=125, Not yet recruiting, Wugen, Inc.
    New P2 trial • CAR T-Cell Therapy • Minimal residual disease
    |
    WU CART 007
    11ms
    A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL (clinicaltrials.gov)
    P1/2, N=44, Active, not recruiting, Wugen, Inc.
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    WU CART 007
    11ms
    Phase 1/2 Dose-Escalation/Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) (TCT-ASTCT-CIBMTR 2024)
    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.
    P1/2 data • CAR T-Cell Therapy • IO biomarker
    |
    CCR7 (Chemokine (C-C motif) receptor 7) • CD7 (CD7 Molecule)
    |
    Actemra IV (tocilizumab) • WU CART 007
    12ms
    A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL (clinicaltrials.gov)
    P1/2, N=44, Active, not recruiting, Wugen, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    WU CART 007
    1year
    Phase 1/2 Dose-Escalation/Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) (ASH 2023)
    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.
    P1/2 data • CAR T-Cell Therapy • IO biomarker
    |
    CCR7 (Chemokine (C-C motif) receptor 7) • CD7 (CD7 Molecule)
    |
    cyclophosphamide • dexamethasone • fludarabine IV • Actemra IV (tocilizumab) • WU CART 007
    1year
    Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=54, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    CD7 (CD7 Molecule)
    |
    CD7 expression
    |
    WU CART 007
    over1year
    PHASE 1/2 DOSE-ESCALATION STUDY OF ANTI-CD7 ALLOGENIC CAR-T CELL IN RELAPSED OR REFRACTORY(R/R) T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA(T-ALL/LBL) (EHA 2023)
    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.
    P1/2 data • CAR T-Cell Therapy
    |
    cyclophosphamide • dexamethasone • fludarabine IV • Actemra IV (tocilizumab) • WU CART 007
    over1year
    Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies (clinicaltrials.gov)
    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
    Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD7 (CD7 Molecule)
    |
    CD7 expression
    |
    WU CART 007
    almost2years
    Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies (clinicaltrials.gov)
    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
    Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD7 (CD7 Molecule)
    |
    CD7 expression
    |
    WU CART 007
    2years
    Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies (clinicaltrials.gov)
    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
    Trial completion date • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD7 (CD7 Molecule)
    |
    CD7 expression
    |
    WU CART 007
    over2years
    Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Washington University School of Medicine
    New P1 trial • CAR T-Cell Therapy
    |
    CD7 (CD7 Molecule)
    |
    CD7 expression
    |
    WU CART 007
    almost3years
    A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/ Lymphoblastic Lymphoma (LBL) (ASH 2021)
    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.
    Clinical • P1/2 data • CAR T-Cell Therapy • IO biomarker
    |
    CD7 (CD7 Molecule)
    |
    CD7 overexpression
    |
    cyclophosphamide • fludarabine IV • WU CART 007
    3years
    Characterization of WU-CART-007, an Allogeneic CD7-Targeted CAR-T Cell Therapy for T-Cell Malignancies (ASH 2021)
    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).
    CAR T-Cell Therapy
    |
    CD34 (CD34 molecule) • CD7 (CD7 Molecule)
    |
    WU CART 007