Status:
RECRUITING
Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia
Lead Sponsor:
Seoul National University Hospital
Conditions:
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05210907
Start Date
February 15 2022
End Date
August 31 2026
Last Update
February 6 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080