NCT05995028Not yet recruitingPhase 1
Universal 4SCAR7U Targeting CD7-positive Malignancies
Safety and Efficacy of Universal 4SCAR7U T Cell Therapy Targeting CD7-positive Hematological Malignancies
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 Aug 2023
- Start date
- 30 Jun 2027
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- NCT number
- NCT05995028
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 30 Jun 2027 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
- Previous treatment with any gene therapy products.
Other illness
- Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
- Active bacterial, fungal or viral infection not controlled by adequate treatment.
- Known HIV or hepatitis C virus (HCV) infection.
Other
- Pregnant or nursing women may not participate.
- Patients, in the opinion of investigators, may not be able to comply with the study.
Who the study is looking for
- Age older than 6 months.
- Confirmed expression of CD7 and additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.
- Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months.
- 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.
- Hgb≥80g/L.
- No cell separation contraindications.
- Abilities to understand and the willingness to provide written informed consent.
Age in the registry: 6 months to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen Geno-immune Medical Institute Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.