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)
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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 therapy to induce complete Minimum Residual Disease (MRD) negative response
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:
• 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 (Adults age \> 16) or Lansky Performance Status 70 and above (pediatrics/ adolescents age ≤16).
Locations
United States
California
City of Hope
RECRUITING
Duarte
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Missouri
Washington University Saint Louis
RECRUITING
St Louis
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Australia
Peter Mac Callum Cancer Institute
RECRUITING
Melbourne
Royal Children's Melbourne
RECRUITING
Melbourne
Contact Information
Primary
Wugen Clinical Trials
clinicaltrials@wugen.com
314-501-1968
Time Frame
Start Date: 2025-01-31
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 125
Treatments
Experimental: WU-CART-007
A CD7-directed chimeric antigen receptor (CAR) T-cell product.~Lymphodepletion
Related Therapeutic Areas
Sponsors
Leads: Wugen, Inc.