RECRUITING

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)

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Conditions

T-cell Acute Lymphoblastic LeukemiaLymphoblastic LymphomaCAR-T Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response

Official Title

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)

Quick Facts

Study Start:2025-01-31
Study Completion:2028-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06514794

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.

Ages Eligible for Study:1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive, defined as:
  2. * Relapsed or Refractory Cohort: disease defined by bone marrow with ≥5% lymphoblasts by morphologic assessment or flow cytometry or evidence of extramedullary disease (EMD).
  3. * Minimal Residual Disease (MRD) Cohort: evidence of MRD, defined as \< 5% blasts in bone marrow but ≥ 0.01% blasts determined by central laboratory flow cytometry assay
  4. * Adequate Organ Function
  5. * Age: Lower age limit of ≥ 1 year.
  6. * Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening (Adults age \> 16) or Lansky Performance Status 60 and above (pediatrics/ adolescents age ≤16).
  1. * Treatment with any prior anti-CD7 therapy.
  2. * Patients with decompensated hemolytic anemia.
  3. * Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression (e.g. steroids). Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.

Contacts and Locations

Study Contact

Wugen Clinical Trials
CONTACT
314-501-1968
clinicaltrials@wugen.com

Principal Investigator

Cherry Thomas, MD
STUDY_DIRECTOR
Wugen, Inc.

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Washington University Saint Louis
Saint Louis, Missouri, 63108
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19390
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Wugen, Inc.

  • Cherry Thomas, MD, STUDY_DIRECTOR, Wugen, Inc.

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 Registration Dates

Study Start Date2025-01-31
Study Completion Date2028-12-30

Study Record Updates

Study Start Date2025-01-31
Study Completion Date2028-12-30

Terms related to this study

Keywords Provided by Researchers

  • CAR-T Therapy

Additional Relevant MeSH Terms

  • T-cell Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma