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CD19-CAR-T cells

Phase 1

B-cell Malignancy | Monoclonal antibody | Other |Avalon GloboCare Corp.|Last Updated: Feb 1, 2022

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical trial landscape

CD19-CAR-T cells · 1 trial · 1 indication

Phase 1 1
NCT03952923CD19-CAR-T in B-cell Malignancies PatientsB-cell Malignancy
COMPLETED11 Analytics
PHASE1COMPLETED
CD19-CAR-T in B-cell Malignancies Patients
B-cell MalignancyUnlock trial analytics
Study Endpoints
Primary Endpoints
Percentage of adverse events
6 months

Percentage of participants with adverse events.

Objective remission rate(ORR)
6 months

The percentage of participants who achieved complete remission (CR) and partial remission over all participants.

Secondary Endpoints
Relapse-Free Survival(RFS )
6 months
Overall-Survival(OS)
6 months
Persistence of CAR-T cells in vivo
6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CD19-CAR-T cellsEXPERIMENTALCD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
Interventions
NameTypeDescription
CD19-CAR-T cellsBIOLOGICALCD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
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Eligibility Criteria
Age Range1 Year to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Relapsed and refractory CD19 positive B-cell acute malignancies with: * Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%); * MRD≥0.1% after allogeneic hematopoietic stem cell transplanta...

Countries:China
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