NCT05210907

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
2mo left

Started Feb 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Feb 2022Aug 2026

First Submitted

Initial submission to the registry

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

January 14, 2022

Last Update Submit

February 3, 2023

Conditions

B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events and its severity

    12 months post SNUH-CD19-CAR-T infusion

Secondary Outcomes (2)

  • Patients with CR[complete remission] after Hospital-manufactured CAR-T infusion

    1 month post SNUH-CD19-CAR-T infusion

  • Overall survival and event-free survival

    12 months post SNUH-CD19-CAR-T infusion

Study Arms (1)

CD19 CAR-T therapy

EXPERIMENTAL

SNUH-CD19-CAR-T is administered as an intravenous infusion.

Biological: SNUH-CD19-CAR-T

Interventions

SNUH-CD19-CAR-TBIOLOGICAL

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.

CD19 CAR-T therapy

Eligibility Criteria

Age0 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. 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
  • \. Documentation of CD19 tumor expression in bone marrow or peripheral blood by flow cytometry.
  • \. Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening

You may not qualify if:

  • Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on assessment done by treating physicians.
  • Known human immunodeficiency virus (HIV) infection.
  • 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.
  • Pregnant or nursing (lactating) women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Hyoungjin Kang, PhD

CONTACT

+82-2-2072-3304kanghj@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

February 15, 2022

Primary Completion

September 30, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

February 6, 2023

Record last verified: 2023-01

Locations

KR(1)