Status:
RECRUITING
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)
Lead Sponsor:
Wugen, Inc.
Conditions:
T-cell Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief Summary
The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a ther...
Detailed Description
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
Inclusion
- Key
- 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 ≥ 1 year; adequate organ function
- Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
January 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06514794
Start Date
January 31 2025
End Date
December 30 2028
Last Update
January 5 2026
Active Locations (10)
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1
City of Hope
Duarte, California, United States, 91010
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
3
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States, 33612
4
Washington University Saint Louis
St Louis, Missouri, United States, 63108