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

NCT ID: NCT04984356

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2024-08-08

Brief Summary

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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

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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

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T-cell Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

There are two parts to this study, Dose Escalation, and Expansion.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

WU-CART-007

Intervention Type BIOLOGICAL

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

Interventions

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WU-CART-007

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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),
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wugen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cherry Thomas, MD

Role: STUDY_DIRECTOR

Wugen, Inc.

Locations

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City of Hope

Duarte, California, United States

Site Status

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Hospital Saint- Louis

Paris, , France

Site Status

University Hospital Robert Debre

Paris, , France

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

Prinses Maxima Centrum

Utrecht, , Netherlands

Site Status

Countries

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United States Australia France Netherlands

References

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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.

Reference Type DERIVED
PMID: 40445850 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39149468 (View on PubMed)

Other Identifiers

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R35CA210084

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Wugen, Inc. is the sponsor.

Identifier Type: OTHER

Identifier Source: secondary_id

WU-CART-007 1001

Identifier Type: -

Identifier Source: org_study_id

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