CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

Clinical Trial for the Efficacy and Safety of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

Study Overview

• Status: Recruiting
• Conditions: Large B-Cell Lymphoma (LBCL)
• Intervention / Treatment: Drug: CD19 CAR-T cells

Detailed Description

This study is indicated for patients with CD19+ newly diagnosed high-risk large B-cell lymphoma. This study is an investigator-initiated, single-center, single-arm phase II clinical trial of rituximab, lenalidomide, and zanubrutinib (ZR2) with Sequential CAR-T cell as first-line therapy for newly diagnosed high-risk LBCL. Primary objective is to explore the efficacy and also safety.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: He Huang, PhD; Phone Number: 86-13605714822; Email: hehuangyu@126.com
• Study Contact Backup: Name: Yongxian Hu, PhD; Phone Number: 86-15957162012; Email: huyongxian2000@aliyun.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital，College of Medicine, Zhejiang University
      • Contact: He Huang, PhD; Phone Number: 86-13605714822; Email: hehuangyu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age no less than 18, no gender limit;
2. Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified;
3. Confirmed CD19 and CD20 postive expressions in lymphoma cells
4. ECOG score 0-2;
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. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Central nervous system involvement by lymphoma；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. Other uncontrolled diseases that were not suitable for this trial;
8. Patients with HIV infection;
9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of CD19 CAR T-cells	Drug: CD19 CAR-T cells; Each subject receive CD19 CAR T-cells by intravenous infusion; Other Names: CD19 CAR-T cells injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete remission rate after CD19 CAR-T cell therapy	Assessment of complete remission rate at 3 months after CD19 CAR-T cell therapy	3 months after CD19 CAR-T cell therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Incidence of treatment-emergent adverse events [Safety and Tolerability]	Up to 2 years after CD19 targeted CAR T-cells infusion
Overall response rate (ORR)	Assessment of ORR after ZR2 and CAR-T cell therapy	After ZR2, 3 months after CAR-T cell therapy
Overall survival (OS)	From the start of treatment to death or the last visit	Up to 2 years after CD19 CAR-T cells infusion
Progression-free survival (PFS)	From the start of the treatment to the occurrence of any event, including death, disease progression (any one occurs first), or the last visit	Up to 2 years after CD19 CAR-T cells infusion
Duration of response (DOR)	among patients experiencing an objective response, defined as the time from the first objective response to events of disease progression or death from any cause	Up to 2 years after CD19 CAR-T cells infusion

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Yake Biotechnology Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: CAR-T; CD19; Large B-Cell Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: CD19-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No