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A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.
Full description
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-cell hematological malignancies, including acute lymphoblastic leukemia and B-cell non-Hodgkin's lymphoma. The selections of dose levels and the numberof subjects are based on clinical trials of similar foreign products. Two groups of patients will be enrolled, 36 in each group. Primary objective is to explore the safety, main consideration is dose-related safety.
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Inclusion criteria
Inclusion criteria only for B-ALL:
Male or female aged 3-70 years;
Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (by morphology), and/or >1% (by flow cytometry);
Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
Inclusion criteria only for B-NHL:
Male or female aged 18-75 years;
Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
Relapsed or refractory B-NHL (meeting one of the following conditions):
At least one assessable tumor lesion per Lugano 2014 criteria;
Common inclusion criteria for B-ALL and B-NHL:
Exclusion criteria
Subjects with any of the following exclusion criteria were not eligible for this trial:
Primary purpose
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72 participants in 1 patient group
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Central trial contact
He Huang, PhD; Yongxian Hu, PhD
Data sourced from clinicaltrials.gov
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