Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia

February 3, 2023 updated by: Seoul National University Hospital

A Phase Ib, Clinical Trial of Hospital-manufactured CD19 Chimeric Antigen Receptor T Cells (SNUH-CD19-CAR-T) in Children and Adolescents With Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia

Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19[cluster of differentiation antigen 19] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

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

  • Name: Hyoungjin Kang, PhD
  • Phone Number: +82-2-2072-3304
  • Email: kanghj@snu.ac.kr

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University 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 second to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Relapsed or refractory CD19 Positive Acute Lymphoblastic Leukemia. All subjects must be younger than 26 years old at the time of obtaining informed consent

    a. 2nd or greater BM[bone marrow] relapse OR b. Any BM relapse after allogeneic SCT[stem cell transplant] and must be ≥ 6 months from SCT at the time of SNUH_CD19_CAR-T infusion OR c .Refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia OR d. Ineligible for allogeneic SCT because of:

    • Severe comorbid disease
    • Other contraindications to allogeneic SCT conditioning regimen

    • Lack of suitable donor

      2. Documentation of CD19 tumor expression in bone marrow or peripheral blood by flow cytometry.

      3. Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening

Exclusion Criteria:

  1. Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on assessment done by treating physicians.
  2. Known human immunodeficiency virus (HIV) infection.
  3. Presence of clinically active uncontrolled infection based on assessment done by treating physicians. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
  4. Pregnant or nursing (lactating) women.

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 therapy
SNUH-CD19-CAR-T is administered as an intravenous infusion.
Biological: SNUH-CD19-CAR-T
SNUH-CD19-CAR-T is an autologous CAR-T from T cells collected from each patient. Administer a single dose of SNUH-CD19-CAR-T to patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia, and evaluate safety and efficacy of SNUH-CD19-CAR-T for 12 months after the infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and its severity
Time Frame: 12 months post SNUH-CD19-CAR-T infusion
12 months post SNUH-CD19-CAR-T infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients with CR[complete remission] after Hospital-manufactured CAR-T infusion
Time Frame: 1 month post SNUH-CD19-CAR-T infusion
1 month post SNUH-CD19-CAR-T infusion
Overall survival and event-free survival
Time Frame: 12 months post SNUH-CD19-CAR-T infusion
12 months post SNUH-CD19-CAR-T infusion

Collaborators and Investigators

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

Sponsor

Seoul National University 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 (ACTUAL)

February 15, 2022

Primary Completion (ANTICIPATED)

September 30, 2025

Study Completion (ANTICIPATED)

August 31, 2026

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (ACTUAL)

January 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH_CART_CD19ALL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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