CD19-CART in the Treatment of R/R CD19 Positive Non-Hodgkin's Lymphoma

NCT ID: NCT04237428

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2021-05-31

Brief Summary

To evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor T cell infusion in the treatment of relapsed or refractory CD19 positive non-Hodgkin's lymphoma.

Conditions

Non Hodgkin Lymphoma

Study Design

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

Study Groups

hCD19 CAR-T cells Infusion

Group Type: EXPERIMENTAL

CD19 CAR-T cells infusion

Intervention Type: BIOLOGICAL

Biological: CD19 CAR-T cells infusion Biological: CD19 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD19 CAR-T cells infusion are allowed within 2 weeks after treatment.

CD19 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD19 CAR-T cells are infused into patients for one time, the number of infused CD19 CAR-T cells are 0.5-4×10^6/kg.

Interventions

CD19 CAR-T cells infusion

Biological: CD19 CAR-T cells infusion Biological: CD19 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD19 CAR-T cells infusion are allowed within 2 weeks after treatment.

CD19 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD19 CAR-T cells are infused into patients for one time, the number of infused CD19 CAR-T cells are 0.5-4×10^6/kg.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Non Hodgkin's lymphoma was confirmed by histological examination, and one of the following conditions was met:

1. Relapsed and refractory CD19 positive diffuse large B-cell lymphoma: at least after the standard second-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission or disease progression after partial remission, or relapsed after complete remission;

2. Relapsed and refractory CD19 positive follicular lymphoma: at least after the standard three-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission and disease progress after partial remission, or relapsed after complete remission;

3. Relapsed refractory CD19 positive diffuse large B-cell lymphoma and follicular lymphoma: primary drug resistance; relapse within 1 year after autologous stem cell transplantation only, not affected by other treatment methods previously used; CD20 positive patients should receive corresponding targeted treatment;

2. Age: 18-65 years (including boundary value), gender unlimited;

3. The expected survival time was more than 3 months;

4. ECOG score 0-1 (dose increasing stage), ECoG score 0-2 (expanding group stage);

5. The functions of liver and kidney, heart and lung meet the following requirements:

① Creatinine ≤ 1.5 ULN

②ALT/AST ≤2.5 ULN；

③ Total bilirubin ≤ 1.5 × ULN;

④ Baseline oxygen saturation ≥ 92%;

⑤ No pericardial effusion was detected by echo;

6. According to Lugano's response standard, there should be at least one measurable tumor focus;

7. Be able to understand the test and have signed the informed consent.

Exclusion Criteria

1. Before screening, they received other chimeric antigen receptor therapy or gene modified cell therapy;

2. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the DNA titer of peripheral blood hepatitis B virus (HBV) is not within the normal reference range; hepatitis C virus (HCV) antibody is positive and peripheral blood HCV RNA is positive; human immunodeficiency virus (HIV) antibody is positive; cytomegalovirus (CMV) DNA is positive; syphilis is positive ;

3. Subjects who were undergoing systemic steroid therapy at the time of screening and who were determined by the investigator to require long-term systemic steroid therapy during the treatment (except for inhalation or local use);

4. In addition to cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation, malignant tumors other than B-cell acute lymphoblastic leukemia in the first 5 years were screened;

5. Subjects with graft-versus-host disease (GVHD), autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus and Crohn's disease) and / or requiring immunosuppressant within 2 years;

6. Any unstable heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ grade III) and severe arrhythmia;

7. Any unstable systemic diseases: including but not limited to liver, kidney or metabolic diseases requiring drug treatment;

8. Subjects who received stem cell transplantation within 6 weeks after CD19 car-t infusion were planned;

9. Invasion of central nervous system;

10. Pregnant women and lactating women; and female subjects who plan pregnancy within 1 year after cell transfusion or male subjects whose partners plan pregnancy within 1 year after cell transfusion;

11. According to the judgment of the researchers, it does not conform to the situation of cell preparation;

12. Other researchers think it's not suitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingzhi Zhang, Doctor

Role: CONTACT

mingzhi_zhang@126.com

+8613838565629

Facility Contacts

Min Yao, Bachelor's

Role: primary

1248135168@qq.com

+8618355313511

Other Identifiers

PG-CART-19-001

Identifier Type: -

Identifier Source: org_study_id