CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.
Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
1 other identifier
interventional
20
1 country
1
Brief Summary
This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2017
Longer than P75 for phase_1
1 active site
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 Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 28, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 29, 2023
November 1, 2023
7.3 years
July 28, 2018
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events
Adverse events are evaluated with CTCAE V4.03
12 months
Study Arms (1)
Cohort 1
EXPERIMENTALExperimental: Cohort 1 Intervention: Biological: CART-19/22 This cohort will determine the safety and efficacy of targeted CD19/CD22 chimeric Antigen Receptor Engineered T Cell Immunotherapy (CART) in the Treatment of CD19/CD22 Positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
Interventions
Split intravenous infusion of CART-19/22 cells of (Dose escalating infusion of 1 - 20 x10\^6 CART-19/22 cells/kg).
Eligibility Criteria
You may qualify if:
- Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to \<2 year). The study will enroll 20 evaluable patients as follows:
- Age 6-65 years.
- Left ventricular ejection fractions≥ 0.5 by echocardiography.
- Creatinine \< 1.6 mg/dL.
- Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal.
- Bilirubin \<2.0 mg/dL.
- Karnofsky performance status ≥ 60
- Expected survival time ≥ 3 months (according to investigator's judgement)
You may not qualify if:
- Pregnant or lactating women.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- HIV infection.
- Patients with history of seizure
- Active central nervous system leukemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaowen Tang, Ph.D.
The First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2018
First Posted
August 3, 2018
Study Start
September 1, 2017
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
November 29, 2023
Record last verified: 2023-11