A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL
NCT ID: NCT04984356
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2022-01-14
2024-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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WU-CART-007
A CD7-directed chimeric antigen receptor (CAR) T-cell product.
A single IV infusion of WU-CART-007 Cells on Day 1 after lymphodepletion
WU-CART-007
A single IV infusion of WU-CART-007 Cells on Day 1
Interventions
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WU-CART-007
A single IV infusion of WU-CART-007 Cells on Day 1
Eligibility Criteria
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Inclusion Criteria
* Diagnosed relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification
* Adequate renal, hepatic, respiratory, and cardiovascular function
* Life expectancy \>12 weeks
* ECOG/Karnofsky performance status 0 or 1 at screening (Adults age \>16) or Lansky Performance Status 60 and above (adolescents ≤ 16),
12 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wugen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cherry Thomas, MD
Role: STUDY_DIRECTOR
Wugen, Inc.
Locations
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City of Hope
Duarte, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Washington University
St Louis, Missouri, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Wisconsin
Madison, Wisconsin, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Hospital Saint- Louis
Paris, , France
University Hospital Robert Debre
Paris, , France
Erasmus MC
Rotterdam, , Netherlands
Prinses Maxima Centrum
Utrecht, , Netherlands
Countries
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References
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Ghobadi A, Aldoss I, Maude SL, Bhojwani D, Wayne AS, Bajel A, Dholaria B, Faramand R, Mattison RJ, Rijneveld A, Zwaan CM, Calkoen F, Baruchel A, Boissel N, Rettig M, Wood B, Jacobs K, Christ S, Irons H, Capoccia B, Masters D, Gonzalez J, Wu T, Rosario MD, Hamil A, Bakkacha O, Muth J, Ramsey B, McNulty E, Baughman J, Cooper ML, Davidson-Moncada J, DiPersio JF. Phase 1/2 trial of anti-CD7 allogeneic WU-CART-007 for patients with relapsed/refractory T-cell malignancies. Blood. 2025 Sep 4;146(10):1163-1173. doi: 10.1182/blood.2025028387.
Ghobadi A, Aldoss I, Maude S, Bhojwani D, Wayne A, Bajel A, Dholaria B, Faramand R, Mattison R, Rijneveld A, Zwaan C, Calkoen F, Baruchel A, Boissel N, Rettig M, Wood B, Jacobs K, Christ S, Irons H, Capoccia B, Gonzalez J, Wu T, Del Rosario M, Hamil A, Bakkacha O, Muth J, Ramsey B, McNulty E, Cooper M, Baughman J, Davidson-Moncada J, DiPersio J. Anti-CD7 allogeneic WU-CART-007 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma: a phase 1/2 trial. Res Sq [Preprint]. 2024 Aug 5:rs.3.rs-4676375. doi: 10.21203/rs.3.rs-4676375/v1.
Other Identifiers
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Wugen, Inc. is the sponsor.
Identifier Type: OTHER
Identifier Source: secondary_id
WU-CART-007 1001
Identifier Type: -
Identifier Source: org_study_id
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