CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma

March 19, 2019 updated by: Henan Cancer Hospital

Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma

Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.

Study Type

Interventional

Enrollment (Anticipated)

50

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 Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
        • Sub-Investigator:
          • Quanli Gao, Dr.

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

13 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • expected lifetime>3 months
  • CD19/CD20 positive relapsed/refractory B cell lymphoma
  • KPS>70
  • at least one measurable lesion according to RECIST 1.1
  • enough function of hear, liver, kidney and bone marrow
  • no history of severe allergies
  • no other history of malignancy
  • no other diseases that conflict with this regimen
  • no serious mental illness
  • patient or family member sign informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Severe infectious or viral disease
  • Active B or C viral hepatitis
  • Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
  • participated in other clinical studies in the last 3 months, or have been treated with other gene products
  • Others not appropriate to participate in this study examined by the investigators

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm
CAR-T cell group
Biological: CD19/CD20 bispecific CAR-T cells
collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of study related adverse events
Time Frame: one year
safety of CAR-T cells
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: three months
proportion of patients with complete response and partial response
three months
survival time of CAR-T cells in vivo
Time Frame: one year
from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo
one year
progression-free survival
Time Frame: one year
the enrollment to the first time that disease progression is detected
one year

Collaborators and Investigators

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

Sponsor

Henan Cancer Hospital

Collaborators

Henan Hualong Biotechnology Company

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)

February 1, 2019

Primary Completion (Anticipated)

January 31, 2021

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

March 16, 2019

First Submitted That Met QC Criteria

March 16, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanCH CART 2-3

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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