A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies

June 17, 2017 updated by: Second Affiliated Hospital of Guangzhou Medical University

A Prospective, Multicenter, Single-Arm Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies

Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Despite progress has been made to date in the treatment of patients with B cell malignancies, including leukemia and lymphoma, many patients with relapsed or refractory diseases do not respond to the standard treatments. It has been shown that anti-CD19 CAR-transduced T cells may be an effective approach to treat the relapsed or refractory diseases. The procedure involves collecting PBMCs from the patients and modifying the T cells to attack the malignant B cells. In this trial, autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) containing the signaling domains of CD28 or 4-1BB and CD3-zeta will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be pretreated with a lymphodepleting preconditioning regimen before the infusion of anti-CD19 CAR T cells, and will be monitored for safety, adverse events, persistence of anti-CD19 CAR-transduced T cells and the treatment efficacy.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • 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

  • Name: Ying Feng, MD
  • Phone Number: 0086 13602723030
  • Email: fyzlply@163.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Dongguan, Guangdong, China
        • Recruiting
        • Department of Hematology, Dongguan People's Hospital
        • Contact:
        • Principal Investigator:
          • Yirong Jiang, MD
      • Foshan, Guangdong, China
        • Recruiting
        • Department of Hematology, the First People's Hospital of Foshan
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhuowen Chen, MD
      • Guangzhou, Guangdong, China
        • Recruiting
        • Department of Hematology, Guangzhou First People's Hospital
        • Principal Investigator:
          • Shunqing Wang, MD
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Department of Hematology, The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:
        • Principal Investigator:
          • Xueyi Pan, MD
      • Guangzhou, Guangdong, China
        • Recruiting
        • Department of Hematology,the Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • Ying Feng, MD

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

14 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients must have a CD19+ B cell malignancy，including relapsed or refractory B cell leukemia and/or B cell lymphoma；
  2. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis；
  3. Patients with history of allogeneic stem cell transplantation are eligible, providing 6 months had elapsed from SCT, they have no evidence of active graft-versus-host disease (GVHD) and no longer taking immunosuppressive agents during the treatment;
  4. Able to understand and sign the Informed Consent Document；
  5. There is no obvious dysfunctions in heart , liver, lung, kidney, and performance status with ECOG < 2；
  6. Life expectancy：More than 3 months for leukemia and more than 6 months for lymphoma.

Exclusion Criteria:

  1. Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression；
  2. Patients that have active hemolytic anemia；
  3. Patients who have uncontrollable infectious diseases within 2 weeks before enrollment;
  4. Patients with human immunodeficiency virus (HIV) antibody seropositive;
  5. Active infection of Hepatitis B virus and / or hepatitis C virus;
  6. Patients with any residual intracranial implants；
  7. Coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system；
  8. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)；
  9. Concurrent opportunistic infections；
  10. Concurrent systemic steroid therapy；
  11. History of severe immediate hypersensitivity reaction to any of the agents used in this study；
  12. Women of child-bearing potential who are pregnant or breastfeeding；
  13. Patients with cardiac atrial or cardiac ventricular lymphoma involvement；
  14. Other anti-neoplastic investigational agents currently or within 30 days prior to start of the treatment；
  15. Psychiatric patients;
  16. Previous treatment with any gene therapy products.

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: Anti-CD19 CAR transduced T cells
Patients will receive a lymphodepleting preconditioning regimen with Fludarabine and Cyclophosphamide followed by anti-CD19 CAR-transduced T cells.
Combination product: Drugs and anti-CD19 CAR transduced T cells

Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes.

Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine.

Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse Events
Time Frame: 24 months
To evaluate the safety and feasibility of the administration of anti-CD19 CAR transduced T cells in patients with refractory /relapsed CD19+ B cell malignancies.
24 months
Number of participants with clinical responses
Time Frame: 24 months
To determine if the treatment regimen can result in clinical regression of B cell malignancies in the patients as described above.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of overall survial
Time Frame: 24 months
To evaluate overall survial(OS) after administration of anti-CD19 CAR transduced T cells in patients with refractory /relapsed CD19+ B cell malignancies.
24 months

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Collaborators

Guangzhou First People's Hospital
First People's Hospital of Foshan
Dongguan People's Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University
Shenzhen Institute for Innovation and Translational Medicine

Investigators

  • Study Director: Ying Feng, MD, Second Affiliated Hospital of Guangzhou Medical University
  • Study Director: Mingjun Wang, MD, Shenzhen Institute for Innovation and Translational Medicine

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 (Anticipated)

June 30, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 17, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-HS-32

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

product manufactured in and exported from the U.S.

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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