CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

November 27, 2023 updated by: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Study Type

Interventional

Enrollment (Estimated)

10

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
      • Suzhou, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • 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

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
  2. ALT/ AST 《 3x normal
  3. Creatinine 《 3x normal
  4. Age:10-60.
  5. Signed informed consent

Exclusion Criteria:

  1. Active hepatitis B , hepatitis C or HIV infection
  2. Uncontrolled active infection
  3. Pregnancy or breast-feeding women
  4. Survival less than four weeks

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: Arm 1
CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.
Biological: CD19 CAR-T cells
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The complete remission (CR) rate
Time Frame: Participants will be followed for the duration of the treatment, an expected average of 12 months
The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined
Participants will be followed for the duration of the treatment, an expected average of 12 months

Collaborators and Investigators

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

Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Collaborators

The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Sheng-Li Xue, Ph.D, The First Affiliated Hospital of Soochow 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 (Actual)

March 1, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 18, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UnicarTherapy

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

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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