Clinical trial · Interventional
Universal 4SCAR7U Targeting CD7-positive Malignancies
Safety and Efficacy of Universal 4SCAR7U T Cell Therapy Targeting CD7-positive Hematological Malignancies
NCT05995028CI-TRIAL-00124037not yet recruitingPhase 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 clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| NK Cell Lymphoma | — | UNRESOLVED | — |
| T-cell Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| T-cell Acute Lymphoblastic Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Universal CD7-specific CAR gene-engineered T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Universal 4SCAR7U cells to treat CD7-positive hematological malignancies
- interventionNames
- Biological: Universal CD7-specific CAR gene-engineered T cells
Primary outcomes (1)
- measure
- Safety of infusion
- timeFrame
- 6 months
- description
- Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
Secondary outcomes (1)
- measure
- Clinical response
- timeFrame
- 1 year
- description
- Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age older than 6 months. 2. Confirmed expression of CD7 and additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry. 3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months. 4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. 5. Hgb≥80g/L. 6. No cell separation contraindications. 7. Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: 1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. Active bacterial, fungal or viral infection not controlled by adequate treatment. 3. Known HIV or hepatitis C virus (HCV) infection. 4. Pregnant or nursing women may not participate. 5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial. 6. Previous treatment with any gene therapy products. 7. Patients, in the opinion of investigators, may not be able to comply with the study.
References
Publications (0)
Data not yet available
No reference posted for this study.