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)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorWugen, Inc.

About this trial

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

Eligibility criteria

Qualifiers

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 ≥ 6 months; adequate organ function

Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • WU-CART-007

Treatment groups

125 Participants
are divided into 1 treatment group

Locations

15
Australia
Peter Mac Callum Cancer Institute3000, MelbourneVictoria, Australia
Royal Children's Melbourne3000, MelbourneVictoria, Australia
United States
California
City of Hope91010, Duarte United States
Children's Hospital Los Angeles90027, Los Angeles United States

Sponsors and collaborators

Wugen, Inc.

Lead sponsor