NCT04984356

A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Wugen, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T-cell Acute Lymphoblastic Leukemia
• Lymphoblastic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	WU-CART-007	A single IV infusion of WU-CART-007 Cells on Day 1

Timeline

• Start date: 2022-01-14
• Primary completion: 2024-08-08
• Completion: 2024-08-08
• First posted: 2021-07-30
• Last updated: 2025-09-30

Locations

12 sites across 4 countries: United States, Australia, France, Netherlands

Regulatory

• FDA-regulated drug study