CD19 CAR-T Therapy for Patients With B-cell Non-Hodgkin's Lymphoma

NCT ID: NCT04661020

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2026-12-20

Brief Summary

A Study of CD19 CAR-T Therapy for Patients With B-cell Non-Hodgkin's Lymphoma.

Detailed Description

This is a single arm, open-label, single-center study. This study is indicated for patients with CD19+ non-Hodgkin's lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Conditions

Non-hodgkin Lymphoma,B Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration of CD19 CAR T-cells

Group Type: EXPERIMENTAL

CD19 CAR-T cells

Intervention Type: DRUG

Each subject receive CD19 CAR T-cells by intravenous infusion

Interventions

CD19 CAR-T cells

Each subject receive CD19 CAR T-cells by intravenous infusion

Intervention Type: DRUG

Other Intervention Names

CD19 CAR-T cells injection

Eligibility Criteria

Inclusion Criteria

1. Age no less than 18, no gender limit;

2. Histologically confirmed diagnosis of HGBCL（HGBCL-NOS、HGBCL involving combined rearrangements of MYC, bcl-2 and bcl-6）DLBCL、not otherwise specified and IPI≥3;

3. Newly diagnosed B-NHL, unwilling to receive RCHOP first- or second-line chemotherapy, but willing to receive targeted drugs (such as a regimen consisting of CD20 monoclonal antibody，lenalidomide and Brutons tyrosine kinase inhibitor for two courses) as preconditioning regimens for CAR-T cell therapy;

4. Patients with PR or SD efficacy evaluated by PET-CT after two courses of tumor reduction therapy;

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

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

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

8. Estimated survival time ≥ 3 months;

9. ECOG performance status 0 to 2;

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

Exclusion Criteria

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;

2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

3. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);

4. Active infection of hepatitis B virus or hepatitis C virus;

5. Previously treated with any CAR-T cell product or other genetically modified T cell therapies;

6. Insufficient amplification capacity in response to CD3 / CD28 co-stimulus signal (<5 times) ;

7. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;

8. Other uncontrolled diseases that were not suitable for this trial;

9. Patients with HIV infection;

10. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, PhD

Role: CONTACT

hehuangyu@126.com

86-13605714822

Yongxian Hu, PhD

Role: CONTACT

huyongxian2000@aliyun.com

86-15957162012

Facility Contacts

He Huang, PhD

Role: primary

hehuangyu@126.com

86-13605714822

Other Identifiers

CD19-003

Identifier Type: -

Identifier Source: org_study_id