Phase I Study of CD19-CAR-T2 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Acute Leukemia

September 8, 2017 updated by: Guangdong Provincial People's Hospital

CD19-CAR-T2 Cells for Relapse/Refractory CD19 Positive Acute Leukemia-a Phase I Trial

The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong General Hospital
        • Contact:

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 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with relapsed and/or refractory CD19 positive B-cell acute leukemia
  • Eastern Cooperative Oncology Group (ECOG) performance status 《 3
  • ALT/ AST 《 3x normal
  • Bilirubin < 2.0 mg/dl
  • Creatinine < 2.5 mg/dl and less than 2.5x normal for age
  • LVEF》 45%
  • Accept white blood cell collection
  • Provide informed consent

Exclusion Criteria:

  • Previous treatment with investigational gene or cell therapy medicine products
  • Solitary extramedullary relapse
  • Active hepatitis B , hepatitis C or HIV infection
  • Uncontrolled active infection
  • Presence of grade 2-4 acute or extensive chronic GVHD
  • Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
  • Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • Received non-diagnostic purposes major surgery within the past 4 weeks
  • Participated in any other clinical study within the past 4 weeks
  • Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
  • Pregnancy or breast-feeding women
  • Use of prohibited drugs:
  • Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion
  • Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion
  • GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion
  • Chemotherapy: i. The following drugs must be stopped > 1 week prior to CTL019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate <25 mg/m2, cytosine arabinoside < 10 mg/m2/day, asparaginase; ii. The following drugs must be stopped > 4 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs
  • Any situation that may increase the risk of the test or interfere with the test results

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: CD19-CAR-T2 T Cells
The subject's T cells will be modified to those which could identify and kill the tumor cells (CD19+ cells). These CD19-CAR-T2 T cells will be infused over 10-15 minutes on days Day 1, 2 and 3 tentatively according to the response to infusion.
Biological: CD19-CAR-T2 Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The maximum tolerated dose(MTD) of CD19 positive relapsed/ refractory acute leukimia treated wtih CD19-CAR-T2 cells
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame: 12 months
Adverse events and laboratory abnormalities (type, frequency and severity)
12 months
Overall Response Rate
Time Frame: 12 months
Overall Response Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
12 months

Collaborators and Investigators

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

Sponsor

Guangdong Provincial People's Hospital

Collaborators

Chinese Academy of Sciences
Guangdong Zhaotai InVivo Biomedicine Co. Ltd.

Investigators

  • Principal Investigator: Jianyu Weng, Dr., Guangdong Provincial People's Hospital
  • Principal Investigator: Peilong Lai, Dr., Guangdong Provincial People's Hospital

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

January 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.GDREC2016198H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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