CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

September 13, 2018 updated by: Tianjin Mycure Medical Technology Co., Ltd

Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.

Study Type

Interventional

Enrollment (Anticipated)

18

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 Locations

  • China
    • Hebei
      • Langfang, Hebei, China, 065000
        • Recruiting
        • Hebei yanda Ludaopei Hospital

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

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. More than 1 year;
  2. CD19 positive B-cell acute lymphoblastic leukemia;
  3. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
  4. Expected to survive for more than 3 months;
  5. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

  1. Recent or current use of glucocorticoid or other immunosuppressor;
  2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
  3. Has a graft-versus-host response and requires the use of immunosuppressants；
  4. Drug uncontrollable central nervous system leukemia；
  5. Pregnant or lactating female；
  6. The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
  7. A history of other malignant tumors;
  8. 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.

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: CD19-CAR-T Cells
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
Biological: CD19 CAR-T cells
T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of adverse events
Time Frame: 6 months
Percentage of participants with adverse events
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete remission rate
Time Frame: 6 months
The percentage of participants who achieved complete remission (CR) over all participants (CRR).
6 months
objective remission rate
Time Frame: 6 months
The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR).
6 months

Collaborators and Investigators

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

Sponsor

Tianjin Mycure Medical Technology Co., Ltd

Investigators

  • Principal Investigator: Peihua Lu, PhD,MD, Hebei yanda Ludaopei Hospital

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)

September 7, 2018

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (ACTUAL)

September 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TianjinMycure-LDP-CD19 CAR-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We don't decide when to share IPD and what will be shared.

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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