A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)
NCT ID: NCT06514794
Last Updated: 2026-01-05
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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RECRUITING
PHASE2
125 participants
INTERVENTIONAL
2025-01-31
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
Relapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease
Minimal Residual Disease (MRD) Positive Cohort will evaluate patients in complete remission with MRD positive disease.
TREATMENT
NONE
Study Groups
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WU-CART-007
A CD7-directed chimeric antigen receptor (CAR) T-cell product.
Lymphodepletion
WU-CART-007
A single IV infusion of WU-CART-007
Interventions
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WU-CART-007
A single IV infusion of WU-CART-007
Eligibility Criteria
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Inclusion Criteria
* Age: Lower age limit of ≥ 1 year; adequate organ function
* Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.
Exclusion Criteria
* 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.
1 Year
ALL
No
Sponsors
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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
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States
Washington University Saint Louis
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Peter Mac Callum Cancer Institute
Melbourne, Victoria, Australia
Royal Children's Melbourne
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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WUC007-03
Identifier Type: -
Identifier Source: org_study_id
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