Status:
UNKNOWN
Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Hematological Malignancies
Chimeric Antigen Receptor T-cell Therapy
Eligibility:
All Genders
16-65 years
Brief Summary
The purpose of this prospective and observational study is to evaluate the correlation between gut microbiota and clinical response to CAR-T treatment for hematological malignancies
Detailed Description
Chimeric antigen receptor T-cell (CAR-T) therapy has shown impressive efficacy in hematological malignancies. However, response rates and associated immune-related adverse effects widely vary among pa...
Eligibility Criteria
Inclusion
- Age 16-65 years.
- Hematologic malignancies intended for CAR-T therapy.
- Expected survival time ≥ 3 months (according to investigator's judgement).
- Left ventricular ejection fractions ≥ 55% by echocardiography.
- ALT / AST \<3 times of normal amounts.
- Creatinine\<2.0mg/dl.
- PT and APPT \<2 times of normal amounts.
- Karnofsky performance status ≥ 60.
- The ECOG score ≤2 points.
Exclusion
- Pregnant (or lactating) women;
- Uncontrolled active infection；
- Active infection of hepatitis B virus or hepatitis C virus；
- Human immunodeficiency virus (HIV) positive；
- Patients with a history of myocardial infarction or severe arrhythmia within six months or those with class III or IV cardiac function according to the New York classification；
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Key Trial Info
Start Date :
September 3 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 2 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06041815
Start Date
September 3 2023
End Date
March 2 2025
Last Update
September 18 2023
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006