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Completed

NCT Number: 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

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).

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Key information

Conditions

T-cell Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoblastic Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

WU-CART-007

Biological

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

Primary outcomes

  1. 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

  2. Maximum Tolerated Dose (MTD)

    Time frame: up to 28 days from first dose

    Maximum tolerated or administered dose of WU-CART-007

Sponsors and collaborators

Lead sponsor

Wugen, Inc.

Industry

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2021
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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