CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia

May 24, 2024 updated by: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia

This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cells； 2. CD19 CAR-T cells with CRS suppression technology.

Study Type

Interventional

Enrollment (Estimated)

40

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

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 200000
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Shengli Xue, 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

6 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 6 to 65
  2. Voluntary informed consent is given
  3. Expected survival ≥12 weeks
  4. Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT
  5. Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin <2.0 mg/dl (3)Creatinine < 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time < 2 times of ULN (5)Arterial oxygen saturation> 92%
  6. Karnofsky score ≥ 60 ;
  7. No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;

Exclusion Criteria:

  1. Uncontrolled active infections
  2. Active hepatitis B or hepatitis C infection
  3. HIV infection
  4. History of myocardio infarction in the past 6 months, or history of severe arrhythmia
  5. Congenital immunodeficiency
  6. Pregnant or lactating women
  7. History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  8. 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Cohort 1
This cohort will determine the safety and efficacy of CD19 CAR-T cells for CD19+ acute lymphoblastic leukemia
Biological: CD19 CAR-T cells
Express a Second Generation 4-1BB: CD19 CAR-T cells
Experimental: Experimental: Cohort 2
This cohort will determine the safety and efficacy of CD19 CAR-T cells with CRS suppression technology for CD19+ acute lymphoblastic leukemia.
Biological: CD19 CAR-T cells with CRS suppression technology
Express a Second Generation 4-1BB:CD19 CAR-T cells with CRS suppression technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of severe CRS
Time Frame: 30 days after infusion of CD19 CAR-T cells
The safety of the CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined
30 days after infusion of CD19 CAR-T cells

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response of CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity.
Time Frame: 30 days after infusion of CD19 CAR-T cells
The efficacy of the CD19 CAR-T cells infusion will be estimated based on the number of participants who have morphology complete remission(CR) and MRD negativity following the CD19 CAR- T cells infusion
30 days after infusion of CD19 CAR-T cells

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: Xiaowen Tang, PhD, 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)

July 1, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UnicarTherapy201701

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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