Clinical trial · Interventional
A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL
A Phase 1 Dose-Escalation and Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)
NCT04984356CI-TRIAL-00096012completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).
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. A single IV infusion of WU-CART-007 Cells on Day 1 after lymphodepletion
- interventionNames
- Biological: WU-CART-007
Primary outcomes (2)
- measure
- Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5
- timeFrame
- 24 months
- description
- Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until end of study visit
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- up to 28 days from first dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Key Eligibility Criteria: * Diagnosed relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification * Adequate renal, hepatic, respiratory, and cardiovascular function * Life expectancy \>12 weeks * ECOG/Karnofsky performance status 0 or 1 at screening (Adults age \>16) or Lansky Performance Status 60 and above (adolescents ≤ 16),
References
Publications (2)
- DERIVEDGhobadi A, Aldoss I, Maude SL, Bhojwani D, Wayne AS, Bajel A, Dholaria B, Faramand R, Mattison RJ, Rijneveld A, Zwaan CM, Calkoen F, Baruchel A, Boissel N, Rettig M, Wood B, Jacobs K, Christ S, Irons H, Capoccia B, Masters D, Gonzalez J, Wu T, Rosario MD, Hamil A, Bakkacha O, Muth J, Ramsey B, McNulty E, Baughman J, Cooper ML, Davidson-Moncada J, DiPersio JF. Phase 1/2 trial of anti-CD7 allogeneic WU-CART-007 for patients with relapsed/refractory T-cell malignancies. Blood. 2025 Sep 4;146(10):1163-1173. doi: 10.1182/blood.2025028387. PMID 40445850
- DERIVEDGhobadi A, Aldoss I, Maude S, Bhojwani D, Wayne A, Bajel A, Dholaria B, Faramand R, Mattison R, Rijneveld A, Zwaan C, Calkoen F, Baruchel A, Boissel N, Rettig M, Wood B, Jacobs K, Christ S, Irons H, Capoccia B, Gonzalez J, Wu T, Del Rosario M, Hamil A, Bakkacha O, Muth J, Ramsey B, McNulty E, Cooper M, Baughman J, Davidson-Moncada J, DiPersio J. Anti-CD7 allogeneic WU-CART-007 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma: a phase 1/2 trial. Res Sq [Preprint]. 2024 Aug 5:rs.3.rs-4676375. doi: 10.21203/rs.3.rs-4676375/v1. PMID 39149468