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)

Wugen, Inc.

Status and phase

Enrolling

Phase 2

Conditions

T-cell Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Treatments

Biological: WU-CART-007

Study type

Interventional

Funder types

Industry

Identifiers

NCT06514794

WUC007-03

Details and patient eligibility

About

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

Full 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.

Enrollment

125 estimated patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Key Exclusion Criteria:

Prior treatment with any anti-CD7 therapy.
Patients with decompensated hemolytic anemia.
Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.