Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory CD19-positive Lymphoma.

August 29, 2021 updated by: Hrain Biotechnology Co., Ltd.

A Phase I Clinical Trial of Human CD19 Targeted T Cells Injection for Subjects With Relapsed and Refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants with relapsed/refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma can participate if all eligibility criteria are met.Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws.Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Fudan University Zhongshan Hospital
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325003
        • Recruiting
        • The First Affilicated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female subjects with CD19+ B cell lymphomas who have a limited prognosis (several months to <2 year survival) with currently available therapies will be enrolled.

  1. 18 to 70 Years Old, Male and female;
  2. Expected survival > 12 weeks;
  3. Clinical performance status of ECOG score 0-1;

  4. Pathology demonstrated that CD19-positive B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:

    1. Relapsed and refractory CD19-positive Diffuse large B-cell lymphoma and Follicular lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR;
    2. Disease recurrence after stem cell transplantation, and at least 1 years after stem cell transplantation.
  5. It can establish the venous access required for collection, satisfying hemoglobin ≥ 70 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L. Mononuclear cell collection can be determined by the investigators;
  6. At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria;

  7. Liver, kidney and cardiopulmonary functions meet the following requirements:

    1. Serum creatinine ≤ 1.5 × ULN;
    2. Left ventricular ejection fraction >50%, no pericardial effusion and no pleural effusion (ECHO examination);
    3. Baseline oxygen saturation > 92%;
    4. Total bilirubin ≤ 1.5 × ULN;
    5. ALT and AST ≤ 3 × ULN.
  8. Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

  1. In the first 5 years before screening, there are malignant tumors other than diffuse large B-cell lymphoma and follicular lymphoma, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery，and catheter carcinoma in situ after radical surgery;
  2. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency Viral (HIV) antibody positive; Positive syphilis test;
  3. Any unstable systemic disease including, but not limited to, active infection (except for local infection), unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia , liver, kidney or metabolic disease requiring medication;
  4. Any other diseases could affect the outcome of this trial;
  5. Any affairs could affect the safety of the subjects or outcome of this trial;
  6. Pregnant or lactating women, or planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;
  7. Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
  8. Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
  9. Received CAR-T treatment or other gene therapies before enrollment;
  10. Patients with symptoms of central nervous system or brain metastasis or have received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatment) within 3 months before enrollment;
  11. Subject suffering disease affects the understanding of informed consent or comply with study protocol;
  12. The investigators consider other conditions unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Human CD19 targeted T Cells Injection
Drug: Human CD19 targeted T Cells Injection
Autologous genetically modified anti-CD19 CAR transduced T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Time Frame: 2 years post infusion
2 years post infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of CAR-positive T cells in circulation
Time Frame: 2 years post infusion
2 years post infusion
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Time Frame: 2 years post infusion
2 years post infusion
Overall remission rate including complete response and Partial response defined by the standard response criteria for malignant lymphoma.
Time Frame: 90 days post infusion
90 days post infusion
Duration of Response after administration
Time Frame: 90 days post infusion
90 days post infusion
Progress Free Survival after administration
Time Frame: 90 days post infusion
90 days post infusion
Overall Survival after administration
Time Frame: 90 days post infusion
90 days post infusion
The immunogenicity of Human CD19 targeted T Cells Injection. (HAMA detection of human anti-mouse antibody)
Time Frame: 2 years post infusion
2 years post infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hrain Biotechnology Co., Ltd.

Collaborators

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2018

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (ACTUAL)

October 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 29, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRAIN01-NHL01
  • CTR20181354 (OTHER: National Medical Products Administration)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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