A Phase 1/2 interventional study of Anti-CD19 CAR-T in Acute Lymphoblastic Leukemia ,Lymphomas, sponsored by The First Affiliated Hospital of Nanchang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-12.
Sponsored by The First Affiliated Hospital of Nanchang University · Phase 1/2, Interventional, and Treatment
This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.
The First Affiliated Hospital of Nanchang University is the lead sponsor of 28 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Subjects diagnosed as Relapsed or Refractory acute lymphoblastic leukemia and Lymphomas ,and have no effective treatment option (such as autograft or allogeneic stem cell transplantation) and estimated survival time of the current treatment \< 2 years, The specific requirements are as follows:
Exclusion Criteria:
Anti-CD19 CAR-T
Biological: Anti-CD19 CAR-T
1 - 2×10\^6 Anti-CD19 CAR-T cells/kg body weigh
Overall responce rate(ORR)
Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
Time frame: 2 years
Overall survival (OS)
Assessment of OS(Overall survival) at 6 months of treatment
Time frame: 2 years
Progression-free survival (PFS)
Assessment of PFS(Progression-free survival ) at 6 months of treatment
Time frame: 2 years
minimal residual disease(MRD)
Assessment of MRD negative overall response rate at 3 months of treatment
Time frame: 2 years
Safety (incidence of adverse events defined as dose-limited toxicity)
Occurrence of study related adverse events defined as NCI CTCAE 4.0 \> grade 3 possibly, probably, or definitely related to study treatment.
Time frame: Study treatment until Week 24
Expression of CD19 CART cells
Expression of CD19 CART cells detected by flow cytometry in blood and bone marrow.
Time frame: 2 years
Detection of CD19 CART cells
Detection of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
Time frame: 2 years
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Nanchang University