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)

Phase 2

Recruiting

• Conditions: T-cell Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
• Interventions: Biological: WU-CART-007

• Registration Number: NCT06514794
• Lead Sponsor: Wugen, Inc.

Brief Summary

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

Detailed Description

This is a Phase 2, single-arm, multi-center, open label study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Study Start: 2025-01-31
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• 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:

  • Relapsed or Refractory Cohort: disease defined by bone marrow with ≥5% lymphoblasts by morphologic assessment or flow cytometry or evidence of extramedullary disease (EMD).
  • 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

• Adequate Organ Function

• Age: Lower age limit of ≥ 1 year.

• 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).

Key

Exclusion Criteria

• Treatment with any prior anti-CD7 therapy.
• Patients with decompensated hemolytic anemia.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WU-CART-007	WU-CART-007	A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion Therapy.

Primary Outcome Measures

Name	Time	Method
R/R Cohort - Composite Complete Response Rate	24 months	CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)
MRD Pos Cohort - Response Rate	24 months	Defined as the efficacy of WU-CART-007 to induce complete MRD negative response

Trial Locations

Locations (7)

City of Hope; 🇺🇸 Duarte, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Washington University Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Peter Mac Callum Cancer Institute; 🇦🇺 Melbourne, Victoria, Australia

Royal Children's Melbourne; 🇦🇺 Melbourne, Victoria, Australia