A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age≥18 years old,gender is not limited;

• Expected survival \> 12 weeks;

• ECOG score 0-2;

• B-cell non-Hodgkin's lymphoma confirmed by cytology or histopathology according to the 2016 World Health Organization (WHO) classification and diagnostic criteria, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed filter Alveolar lymphoma (TFL) and high-grade B-cell lymphoma (HGBCL);

• Pathology demonstrated that B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:

‣ Relapsed and refractory B-cell non-Hodgkin's lymphoma, after standard first-line treatment and at least 2 courses of second-line treatment without remission and relapse (the previous use of CD20-targeted drugs and anthracyclines were needed);

⁃ Relapse of B-cell non-Hodgkin lymphoma after stem cell transplantation, regardless of previous treatments.

• The venous access required for collection can be established and leukepheresis can be carried according to the judgement of investigators, satisfying hemoglobin≥80g/L, neutrophils ≥1.0×10\^9/L, platelets ≥75×10\^9 / L;

• According to the Lugano 2014 criteria, there should be at least one measurable tumor lesion;

• Liver, kidney and cardiopulmonary functions meet the following requirements:

‣ Serum creatinine≤1.5×ULN or creatinine clearance rate≥50mL/min (GockcroftGault formula);

⁃ Cardiac ejection fraction \>50%, no clinically significant pericardial effusion detected, no clinically significant pleural effusion detected;

⁃ Baseline blood oxygen saturation\>92%;

⁃ Total bilirubin≤1.5×ULN(Gilbert syndrome≤5×ULN);

⁃ ALT and AST≤3×ULN (AST and ALT ≤5×ULN in patients with liver metastases);

• Able to understand and sign the Informed Consent Document.

Locations
Other Locations
China
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xuedong Sun, M.D.
sunxuedong@dashengbio.com
+8615811287219
Time Frame
Start Date: 2021-08-09
Estimated Completion Date: 2026-08-09
Participants
Target number of participants: 100
Treatments
Experimental: Human CD19 Targeted T Cells Injection
Single administration:2.0×10\^6 CAR+T/kg
Related Therapeutic Areas
Sponsors
Leads: Hrain Biotechnology Co., Ltd.
Collaborators: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov

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