Clinical Trial for the Safety and Efficacy 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

Who is this study for? Patients with relapsed and/or refractory B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin's lymphoma
What treatments are being studied? Humanized CD19 CAR-T cells
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 75
Healthy Volunteers: f
View:

• 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):

• CR not achieved after standardized chemotherapy;

∙ CR achieved following the first induction, but CR duration is less than 12 months;

∙ Ineffectively after first or multiple remedial treatments;

∙ 2 or more relapses;

⁃ 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):

• No response or relapse after second-line or above chemotherapy regimens;

∙ Primary drug resistance;

∙ Relapse after auto-HSCT;

⁃ At least one assessable tumor lesion per Lugano 2014 criteria;

• Common inclusion criteria for B-ALL and B-NHL:

‣ Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;

⁃ Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;

⁃ No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;

⁃ Estimated survival time ≥ 3 months;

⁃ ECOG performance status 0 to 2;

⁃ Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Locations
Other Locations
China
The First Affiliated Hospital,College of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
He Huang, PhD
hehuangyu@126.com
86-13605714822
Backup
Yongxian Hu, PhD
huyongxian2000@aliyun.com
86-15957162012
Time Frame
Start Date: 2020-08-23
Estimated Completion Date: 2026-08-23
Participants
Target number of participants: 72
Treatments
Experimental: Administration of Humanized CD19 CAR T-cells
Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Sponsors
Collaborators: Yake Biotechnology Ltd.
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov

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