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

September 24, 2025 updated by: Wugen, Inc.

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • Peter MacCallum Cancer Centre
  • France
      • Paris, France
        • Hospital Saint- Louis
      • Paris, France
        • University Hospital Robert Debre
  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus MC
      • Utrecht, Netherlands
        • Prinses Maxima Centrum
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Eligibility Criteria:

  • Diagnosed relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification
  • Adequate renal, hepatic, respiratory, and cardiovascular function
  • Life expectancy >12 weeks
  • ECOG/Karnofsky performance status 0 or 1 at screening (Adults age >16) or Lansky Performance Status 60 and above (adolescents ≤ 16),

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: WU-CART-007
A single IV infusion of WU-CART-007 Cells on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
Maximum Tolerated Dose (MTD)
Time Frame: up to 28 days from first dose
Maximum tolerated or administered dose of WU-CART-007
up to 28 days from first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 24 months
Time from study drug administration (Day 1) to death on study
24 months
Hematopoietic Stem Cell Transplant (HSCT) rate
Time Frame: 24 months
Rate of successful transition to HSCT through study treatment
24 months
Objective Response Rate
Time Frame: 24 months
ORR is defined as proportion of patients that achieve complete remission (CR) + complete remission with incomplete hematologic recover ( CRi) + CR with partial hematologic recovery (CRh), morphologic leukemia free state (MLFS, and partial response (PR) in patients with EMD only
24 months
Duration of Response
Time Frame: 24 months
Time of response to the time of disease relapse, progression or death due to any cause. whichever occurs first
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wugen, Inc.

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Director: Cherry Thomas, MD, Wugen, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Actual)

August 8, 2024

Study Completion (Actual)

August 8, 2024

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WU-CART-007 1001
  • Wugen, Inc. is the sponsor. (Other Identifier: Wugen, Inc. is the sponsor.)
  • R35CA210084 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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