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

Sponsors and collaborators