Clinical Trial for the Safety and Efficacy of CAR-T Cells Therapy for Patients With the Central Nervous System Involvement of Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia or B-cell Non-Hodgkin's Lymphoma

Who is this study for? Patients with the central nervous system involvement of relapsed and/or refractory B-cell acute lymphoblastic leukemia or B-cell non-Hodgkin's lymphoma
What treatments are being studied? CAR-T cells+Ommaya Reservoir
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies

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 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 followingconditions):

• CR not achieved after standardized chemotherapy;

∙ CR achieved following the first induction, but CR duration isless 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 flowcytometry);

⁃ 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 WHOClassification Criteria for Lymphoma (2016);

⁃ Relapsed or refractory B-NHL (meeting one of the followingconditions):

• No response or relapse after second-line or abovechemotherapy 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:

‣ Highly suspected or confirmed central nervous system involvement of hematological malignancies;

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

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

⁃ No active infection in the lungs, blood oxygen saturation in indoorair 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: 2020-11-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 72
Treatments
Experimental: Administration of CAR T-cells
Dose escalation follows the standard 3+3 doseescalation design. A total of 3 dose levels are set for subjects.
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials