Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CD19/CD20 Dual-CAR-T in B-cell Lymphoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260932
Recruitment Status : Not yet recruiting
First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
China Immunotech (Beijing) Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Hebei Yanda Ludaopei Hospital

Brief Summary:
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell lymphoma.

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Biological: CD19/CD20 Dual-CAR-T cells Phase 1

Detailed Description:
This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell lymphoma. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients with refractory and relapsed B-cell lymphoma.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19/CD20 Dual-CAR-T for Patients With B-cell Lymphoma
Estimated Study Start Date : February 10, 2020
Estimated Primary Completion Date : August 10, 2021
Estimated Study Completion Date : November 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for at least 2 days before infusion.
Biological: CD19/CD20 Dual-CAR-T cells
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest at least for 2 days before infusion. CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 1-6×106 cells/kg.




Primary Outcome Measures :
  1. Percentage of participants with adverse events. [ Time Frame: 6 months ]
  2. Objective remission rate(ORR) [ Time Frame: 6 months ]
    The percentage of participants who achieved complete remission (CR) and partial remission over all participants.


Secondary Outcome Measures :
  1. Relapse-Free Survival(RFS ) [ Time Frame: 6 months ]
  2. Overall-Survival(OS) [ Time Frame: 6 months ]
  3. Persistence of CAR-T cells in vivo [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsed and refractory B-cell lymphoma with:

    Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed after autologous or allogeneic hematopoietic stem cell transplantation (ASCT);

  2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
  3. Double positive expression of CD19 / CD20 in B cells;
  4. Ages 1 to 80 years, including boundary values;
  5. ECOG score 0-3 points;
  6. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside;
  7. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.

Exclusion Criteria:

  1. patients with organ failure:

    • Heart: NYHA heart function grade IV;
    • Liver: Grade C that achieves Child-Turcotte liver function grading;
    • Kidney: kidney failure and uremia;
    • Lung: symptoms of respiratory failure;
    • Brain: a person with a disability;
  2. Active infections that are difficult to control;
  3. Human immunodeficiency virus (HIV) positive;
  4. Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;
  5. GVHD ≥ 2 or anti-GVHD treatment;
  6. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
  7. pregnant or lactating women;
  8. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
  9. Patients who participate in other clinical studies at the same time;
  10. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260932


Contacts
Layout table for location contacts
Contact: Xian Zhang, PhD 010-80841201 zhxian2@126.com

Locations
Layout table for location information
China, Hebei
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China, 065200
Contact: Xian Zhang, PhD    010-80841201    zhxian2@126.com   
Sponsors and Collaborators
Hebei Yanda Ludaopei Hospital
China Immunotech (Beijing) Biotechnology Co., Ltd.
Layout table for additonal information
Responsible Party: Hebei Yanda Ludaopei Hospital
ClinicalTrials.gov Identifier: NCT04260932    
Other Study ID Numbers: LDP-DC-001
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin