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

NCT04661020 | Recruiting Phase 2 DMC

• 1 other identifier: CD19-003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-hodgkin Lymphoma,B Cell

Keywords

Non Hodgkin Lymphoma; CAR T-cell therapy; CD19

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Baseline up to 28 days after CD19 targeted CAR T-cells infusion

• 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

Secondary Outcomes (7)

• B-cell Non-Hodgkin's Lymphoma (B-NHL), Overall response rate (ORR)

  At Month 1, 3, 6, 12, 18 and 24

• B-NHL, Overall survival (OS)

  Up to 2 years after CD19 CAR-T cells infusion

• B-NHL, Event-free survival (EFS)

  Up to 2 years after CD19 CAR-T cells infusion

• Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)

  At Baseline, Month 1, 3, 6, 9 and 12

• Activities of Daily Living (ADL) score

  At Baseline, Month 1, 3, 6, 9 and 12

Study Arms (1)

Administration of CD19 CAR T-cells

EXPERIMENTAL

Drug: CD19 CAR-T cells

Interventions

CD19 CAR-T cells DRUG

Each subject receive CD19 CAR T-cells by intravenous infusion

Also known as: CD19 CAR-T cells injection

Administration of CD19 CAR T-cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age no less than 18, no gender limit;
• 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;
• 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;
• Patients with PR or SD efficacy evaluated by PET-CT after two courses of tumor reduction therapy;
• 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.

You may not qualify if:

• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
• Insufficient amplification capacity in response to CD3 / CD28 co-stimulus signal (\<5 times) ;
• Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;
• Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 9, 2020
• Study Start: December 3, 2020
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)