Humanized CAR-T Therapy for Treatment of B Cell Malignancy

August 3, 2017 updated by: Kai Lin Xu; Jun Nian Zheng

Humanized CAR-T Therapy for Treatment of Recurrent or Refractory B Cell Malignancy by Targeting CD19

The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.

Study Type

Interventional

Enrollment (Anticipated)

50

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 Locations

  • China
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Recruiting
        • Huaian First People's Hospital
        • Contact:
          • Chunling Wang, M.D., Ph.D.
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical College
        • Contact:
          • Jiang Cao, M.D., Ph.D.

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

3 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age≥3 at the time of consent
  • Survival time>12 weeks
  • B cell hematological malignancies by pathological examination
  • Chemotherapy failure or recurrent B cell malignancy
  • Creatinine< 2.5mg/dl
  • Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
  • Karnofsky Performance Status>50% at the time of screening
  • Bilirubin<2.0mg/dl
  • Adequate pulmonary, renal, hepatic, and cardiac function
  • Fail in autologous or allogenic haemopoietic stem cell transplantation
  • Free of leukocytes removal contraindications

Exclusion Criteria:

  • Pregnant or nursing women
  • Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
  • Previous treatment with any gene therapy product
  • Abnormal vital signs
  • Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
  • General infection or local severe infection, or other infection that is not controlled
  • Dysfunction in lung, heart, kidney and brain.
  • Severe autoimmune diseases
  • other symptoms that are not applicable for CAR-T

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: CAR-T
In interventional studies, patients enrolled will receive autologous 2nd generation CAR-T cells, which contain a humanized single chain antibody sequence against CD19.
Biological: CAR-T
Patients will be infused with autologous CAR-T infusion in a dose escalating manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAR-T cells persistence in peripheral blood
Time Frame: 12 months
The presence of CAR T cells in patients' peripheral blood will be quantified with real time qPCR
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
B cell number and immunoglobulins in peripheral blood
Time Frame: 12 months
The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods
12 months

Collaborators and Investigators

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

Sponsor

Kai Lin Xu; Jun Nian Zheng

Collaborators

iCarTAB BioMed Inc.
Huaian first people's hospital

Investigators

  • Principal Investigator: KaiLin Xu, MD. Ph.D., Xuzhou Medical University

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

May 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 22, 2016

First Posted (ESTIMATE)

May 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2016-KL002-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

Subscribe