ConditionB-cell Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorShenzhen Geno-Immune Medical Institute
About this trial
The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies. 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.
Eligibility criteria
Qualifiers
aged more than 6 months.
malignant B cell surface expression CD19 molecules.
the KPS score over 80 points, and survival time is more than 3 months.
greater Hgb 80 g/L.
Disqualifiers
accompanied with other active diseases, the treatment is difficult to correct.
bacteria, fungus, or virus infection, unable to control.
people living with HIV.
active HBV and HCV infection.
Trial design
Treatments tested in this trial
- Therapeutic 4SCAR19 cells
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov