4SCAR19U T Cells Targeting B Cell Malignancies
ConditionB Cell Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-75
SponsorShenzhen Geno-Immune Medical Institute
About this trial
The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.
Eligibility criteria
Qualifiers
Age older than 6 months.
Primary B cell surface expression of CD19.
The KPS score over 80 points, and survival time is more than 1 month.
Greater than Hgb 80 g/L.
Disqualifiers
Accompanied with other active diseases, and difficult to assess response after treatment.
Bacterial, fungal, or viral infection, unable to control.
Living with HIV.
Active HBV or HCV infection.
Trial design
Treatments tested in this trial
- Universal CD19-specific CAR gene-engineered T cells
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov