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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WU-CART-007.
- Who it may be relevant to
- Registry conditions: T-cell Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma. Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)
Overview
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.
Interventions
- Biological WU-CART-007
A single IV infusion of WU-CART-007
Primary outcome measures
- R/R Cohort - Composite Complete Response Rate [Time frame: 24 months]
- MRD Pos Cohort - Response Rate [Time frame: 24 months]
Eligibility criteria
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 ≥ 6 months; adequate organ function
- Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- City of Hope — Duarte
- Children's Hospital Los Angeles — Los Angeles
- Colorado Blood Cancer Institute — Denver
- Children's National Hospital — Washington D.C.
- H. Lee Moffitt Cancer Center and Research Institute Hospital — Tampa
- Children's Hospital of Atlanta — Atlanta
- Washington University Saint Louis — St Louis
- Oncology Hematology Care — Cincinnati
- … and 7 more centers
Australia · 2 centers
- Peter Mac Callum Cancer Institute — Melbourne
- Royal Children's Melbourne — Melbourne
Identifiers
NCT: NCT06514794 · WUC007-03