NCT04984356

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2022

Typical duration for phase_1

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2024

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

July 29, 2021

Last Update Submit

September 24, 2025

Conditions

T-cell Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma

Keywords

CAR-T therapy

Outcome Measures

Primary Outcomes (2)

  • Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5

    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)

    Maximum tolerated or administered dose of WU-CART-007

    up to 28 days from first dose

Study Arms (1)

WU-CART-007

EXPERIMENTAL

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

Interventions

WU-CART-007BIOLOGICAL

A single IV infusion of WU-CART-007 Cells on Day 1

WU-CART-007

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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),

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

City of Hope

Duarte, California, 91010, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Location

Hospital Saint- Louis

Paris, France

Location

University Hospital Robert Debre

Paris, France

Location

Erasmus MC

Rotterdam, Netherlands

Location

Prinses Maxima Centrum

Utrecht, Netherlands

Location

Related Publications (2)

  • Ghobadi A, Aldoss I, Maude SL, Bhojwani D, Wayne AS, Bajel A, Dholaria B, Faramand R, Mattison RJ, Rijneveld A, Zwaan CM, Calkoen F, Baruchel A, Boissel N, Rettig M, Wood B, Jacobs K, Christ S, Irons H, Capoccia B, Masters D, Gonzalez J, Wu T, Rosario MD, Hamil A, Bakkacha O, Muth J, Ramsey B, McNulty E, Baughman J, Cooper ML, Davidson-Moncada J, DiPersio JF. Phase 1/2 trial of anti-CD7 allogeneic WU-CART-007 for patients with relapsed/refractory T-cell malignancies. Blood. 2025 Sep 4;146(10):1163-1173. doi: 10.1182/blood.2025028387.

    PMID: 40445850DERIVED

  • Ghobadi A, Aldoss I, Maude S, Bhojwani D, Wayne A, Bajel A, Dholaria B, Faramand R, Mattison R, Rijneveld A, Zwaan C, Calkoen F, Baruchel A, Boissel N, Rettig M, Wood B, Jacobs K, Christ S, Irons H, Capoccia B, Gonzalez J, Wu T, Del Rosario M, Hamil A, Bakkacha O, Muth J, Ramsey B, McNulty E, Cooper M, Baughman J, Davidson-Moncada J, DiPersio J. Anti-CD7 allogeneic WU-CART-007 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma: a phase 1/2 trial. Res Sq [Preprint]. 2024 Aug 5:rs.3.rs-4676375. doi: 10.21203/rs.3.rs-4676375/v1.

    PMID: 39149468DERIVED

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Cherry Thomas, MD

    Wugen, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: There are two parts to this study, Dose Escalation, and Expansion.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

July 30, 2021

Study Start

January 14, 2022

Primary Completion

August 8, 2024

Study Completion

August 8, 2024

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations

NL(2)FR(2)US(7)AU(1)