4SCAR-T Therapy Post CD19-targeted Immunotherapy
ConditionCD19 Negative B-cell Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-75
SponsorShenzhen Geno-Immune Medical Institute
About this trial
This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation 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
Age older than 6 months.
B cell malignancies relapsed after anti-CD19 immunotherapy.
Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20.
The KPS score over 80 points, and survival time is more than 1 month.
Disqualifiers
Complications with other active diseases, and difficult to assess patient response.
Bacterial, fungal, or viral infection unable to control.
Living with HIV.
Active HBV and HCV infection.
Trial design
Treatments tested in this trial
- Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov