4SCAR19 CAR T‑cell treatment for relapsed or refractory CD19‑positive B‑cell cancers
A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies
This trial will test whether 4SCAR19 CAR T cells can help people (age >6 months) with relapsed or refractory CD19‑positive B‑cell malignancies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Drugs / interventions | chimeric antigen receptor, CAR T, chemotherapy, cyclophosphamide, fludarabine |
| Locations | 2 sites (Shenzhen, Guangdong and 1 other locations) |
| Trial ID | NCT03050190 on ClinicalTrials.gov |
What this trial studies
This multi-center phase I/II trial enrolls patients with CD19‑positive B‑cell malignancies that have relapsed or are refractory to standard therapy. Participants undergo apheresis to collect T cells which are modified with a fourth‑generation lentiviral CAR (4SCAR19) incorporating CD28/CD27 costimulatory signals and an inducible caspase‑9 safety switch, then receive a lymphodepleting regimen of cyclophosphamide and fludarabine prior to infusion. The trial will monitor safety, clinical responses, and work to standardize the lentiviral vector and cell production protocol across sites. Early‑phase endpoints focus on toxicity and preliminary anti‑tumor activity.
Who should consider this trial
Good fit: Patients older than 6 months with CD19‑positive B‑cell malignancies that are relapsed or refractory to standard therapies and who are medically fit for lymphodepleting chemotherapy and apheresis are ideal candidates.
Not a fit: Patients without CD19 expression, with uncontrolled infections, active HIV/HBV/HCV, pregnancy or nursing, or who are too frail for lymphodepletion are unlikely to benefit from this therapy.
Why it matters
Potential benefit: If successful, this approach could produce durable remissions in patients who have exhausted standard options while offering a built‑in safety switch to reduce severe treatment toxicities.
How similar studies have performed: Prior CD19‑directed CAR T therapies have achieved high remission rates in B‑ALL and some B‑cell lymphomas, but the 4th‑generation 4SCAR19 design with an inducible caspase‑9 safety switch is newer and less clinically established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. aged more than 6 months. 2. malignant B cell surface expression CD19 molecules. 3. the KPS score over 80 points, and survival time is more than 3 months. 4. greater Hgb 80 g/L. 5. no contraindications to solid and cell separation Exclusion Criteria: 1. accompanied with other active diseases, the treatment is difficult to correct. 2. bacteria, fungus, or virus infection, unable to control. 3. people living with HIV. 4. active HBV and HCV infection. 5. of pregnancy and nursing mothers. 6. before entering the test of the use of glucocorticoid systemic treatment within a week. 7. confirmed before used CAR - but invalid
Where this trial is running
Shenzhen, Guangdong and 1 other locations
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
- The First People's Hospital of Yunnan — Kunming, Yunnan, China (Recruiting)
Study contacts
- Principal investigator: Lung-Ji Chang — Shenzhen Geno-Immune Medical Institute
- Study coordinator: Lung-Ji Chang, PhD
- Email: c@szgimi.org
- Phone: +86 0755-86573763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.