A Phase 1 Dose-Escalation and Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Wugen, Inc.
- Enrollment
- 28
- Locations
- 12
- Primary Endpoint
- Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).
Detailed Description
This is a first-in-human, multicenter, Phase 1, single-arm study in patients with R/R T-ALL/T-LBL who have exhausted other treatment options. The study evaluates dose escalation and dose expansion.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
WU-CART-007
A CD7-directed chimeric antigen receptor (CAR) T-cell product.
A single IV infusion of WU-CART-007 Cells on Day 1 after lymphodepletion
Intervention: WU-CART-007 (Biological)
Outcomes
Primary Outcomes
Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5
Time Frame: 24 months
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until end of study visit
Maximum Tolerated Dose (MTD)
Time Frame: up to 28 days from first dose
Maximum tolerated or administered dose of WU-CART-007
Secondary Outcomes
No secondary outcomes reported