NCT04016129Not yet recruitingPhase 1/2
CAR-T Immunotherapy Targeting CD19- ALL
CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Jul 2019
- Start date
- 1 Jul 2027
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- NCT number
- NCT04016129
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 100
- From 1 Jul 2027 to the primary completion date, 30 Jun 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
- Under systemic steroid use within a week of the treatment.
Other illness
- Complications with other active diseases, and difficult to assess patient response.
- Bacteria, fungus, or virus infection, and unable to control.
- Living with HIV.
- Active HBV and HCV infection.
Other
- Pregnant and nursing mothers.
Who the study is looking for
- Age older than 6 months.
- Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.
- Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR.
- The KPS score over 80 points, and survival time is more than 1 month.
- Greater than Hgb 80 g/L.
- No contraindications to blood cell collection.
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.