RecruitingRecruiting
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)
NCT06514794 · Wugen, Inc.
In plain English
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Official title
A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)
About this study
This is a Phase 2, single-arm, multi-center, open label study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.
Eligibility criteria
Key Inclusion Criteria:
* Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive
* Age: Lower age limit of ≥ 6 months; adequate organ function
* Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.
Key Exclusion Criteria:
* Prior treatment with any anti-CD7 therapy.
* 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.
Study design
Enrollment target: 125 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-01-31
Estimated completion: 2028-12-30
Last updated: 2026-05-12
Interventions
Biological: WU-CART-007
Primary outcomes
- • R/R Cohort - Composite Complete Response Rate (24 months)
- • MRD Pos Cohort - Response Rate (24 months)
Sponsor
Wugen, Inc. · industry
Contacts & investigators
ContactWugen Clinical Trials · contact · clinicaltrials@wugen.com · 314-501-1968
InvestigatorCherry Thomas, MD · study_director, Wugen, Inc.
All locations (15)
City of HopeRecruiting
Duarte, California, United States
Children's Hospital Los AngelesRecruiting
Los Angeles, California, United States
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute HospitalRecruiting
Tampa, Florida, United States
Washington University Saint LouisRecruiting
St Louis, Missouri, United States
Oncology Hematology CareRecruiting
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical CenterRecruiting
Cincinnati, Ohio, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular TherapyRecruiting
Nashville, Tennessee, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Sarah Cannon Transplant and Cellular Therapy Methodist HospitalRecruiting
San Antonio, Texas, United States
Sarah Cannon, Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
Peter Mac Callum Cancer InstituteRecruiting
Melbourne, Victoria, Australia
Royal Children's MelbourneRecruiting
Melbourne, Victoria, Australia