Clinical trial · Interventional
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)
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)
NCT06514794CI-TRIAL-00125690recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoblastic Lymphoma | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
| T-cell Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WU-CART-007 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- WU-CART-007
- description
- A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion
- interventionNames
- Biological: WU-CART-007
Primary outcomes (2)
- measure
- R/R Cohort - Composite Complete Response Rate
- timeFrame
- 24 months
- description
- CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)
- measure
- MRD Pos Cohort - Response Rate
- timeFrame
- 24 months
- description
- Defined as the efficacy of WU-CART-007 to induce complete MRD negative response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
Show eligibility criteria text
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 ≥ 6 months; adequate organ function * Eastern Cooperative Oncology Group (ECOG) 0 or 1/Karnofsky Performance Status 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.
References
Publications (0)
Data not yet available
No reference posted for this study.