Actively Recruiting
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)
Led by Wugen, Inc. · Updated on 2026-05-12
125
Participants Needed
15
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating WU-CART-007, an anti-CD7 allogeneic CAR-T cell therapy, for patients with relapsed or refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (LBL), including those in remission but still testing positive for minimal residual disease (MRD). This Phase 2, single-arm, multi-center, open-label study aims to assess the therapy's ability to induce a complete MRD-negative response and improve outcomes for these patients. Participants will receive a single intravenous infusion of WU-CART-007 after undergoing lymphodepletion treatment. This study involves one treatment group receiving the experimental CAR-T cell therapy. The trial is designed to measure response rates and complete response rates within 24 months after treatment. During the study, patients will be closely monitored through regular assessments to evaluate treatment response and safety. The primary outcomes include the composite complete response rate in the relapsed/refractory cohort and the response rate in the MRD-positive cohort over a 24-month period. The total study duration extends until the end of 2028, allowing for long-term follow-up of participants.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Evidence of T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma as defined by WHO classification
- Disease status of relapse/refractory or minimal residual disease (MRD) positive
- Age at least 6 months or older
- Adequate organ function
- ECOG performance status 0 or 1, or Karnofsky score 70 or above at screening
You will not qualify if you...
- Previous treatment with any anti-CD7 therapy
- Decompensated hemolytic anemia
- Presence of Grade 2 to 4 acute or extensive chronic Graft-versus-Host Disease requiring systemic immunosuppression
- Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD treated with topical therapy only are allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single infusion with follow-up as per protocol
Participants receive a single intravenous infusion of WU-CART-007, an anti-CD7 allogeneic CAR-T cell therapy, following lymphodepletion.
1 treatment visit plus multiple follow-up visits
Trial Site Locations
Total: 15 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
4
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States, 33612
Actively Recruiting
5
Washington University Saint Louis
St Louis, Missouri, United States, 63108
Actively Recruiting
6
Oncology Hematology Care
Cincinnati, Ohio, United States, 45226
Actively Recruiting
7
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
8
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19390
Actively Recruiting
9
TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Sarah Cannon Transplant and Cellular Therapy Methodist Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
12
Sarah Cannon, Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
13
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
14
Peter Mac Callum Cancer Institute
Melbourne, Victoria, Australia, 3000
Actively Recruiting
15
Royal Children's Melbourne
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
W
Wugen Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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