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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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)

Status
Active
Cancer Type
Hematopoietic Malignancies
Leukemia
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase II
Eligibility
1 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06514794
Protocol IDs
WUC007-03 (primary)
NCI-2025-00960
Study Sponsor
Allotera Therapeutics

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

Objectives

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.

Eligibility

  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
  2. Age: Lower age limit of = 6 months; adequate organ function
  3. Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening. Key
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