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

Phase 1

Completed

• Conditions: Lymphoblastic Lymphoma; T-cell Acute Lymphoblastic Leukemia
• Interventions: Biological: WU-CART-007

• Registration Number: NCT04984356
• Lead Sponsor: Wugen, Inc.

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 Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-07-30
• Study Start: 2022-01-14
• Primary Completion: 2024-08-08
• Study Completion: 2024-08-08
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
WU-CART-007	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

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5	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)	up to 28 days from first dose	Maximum tolerated or administered dose of WU-CART-007

Trial Locations

Locations (12)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

City of Hope; 🇺🇸 Duarte, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Washington University; 🇺🇸 St Louis, Missouri, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Hospital Saint- Louis; 🇫🇷 Paris, France

University Hospital Robert Debre; 🇫🇷 Paris, France

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