4SCAR19U T Cells Targeting B Cell Malignancies
ConditionB Cell Malignancies
Trial statusNot yet recruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Universal CD19-specific CAR gene-engineered T cells
Biological/VaccineInfusion of 4SCAR19U cells
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Universal 4SCAR19U cells to treat CD19-positive hematological malignanciesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of 4SCAR19U CAR-T cells infusion
Safety of 4SCAR19U T cells in patients with relapsed and refractory B-ALL, BCL using CTCAE 4 standard to evaluate the level of adverse events
Time frame
24 weeksSecondary outcomes
1
Anti-tumor activity of 4SCAR19U cells after infusion
Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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