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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06041815
Other study ID # gut microbiota + CAR-T
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 3, 2023
Est. completion date March 2, 2025

Study information

Verified date September 2023
Source The First Affiliated Hospital of Soochow University
Contact Xiaowen Tang, PhD
Phone 86-512-67781525
Email xwtang1020@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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 patients. And no biomarkers have been identified to predict the efficacy and associated toxicities after CAR-T therapy in patients. Several preclinical experiments and clinical studies have shown that gut microbiota was associated with the efficacy of T cell-driven cancer immunotherapies and their toxicities. In hematologic malignancies, gut microbiota was associated with the development of graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the potential correlation between gut microbiota and the effificacy and toxicity of CAR-T therapy is unclear. Therefore, in this study, we aim to evaluate the correlation between gut microbiota and clinical response to CAR-T treatment for hematological malignancies.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 2, 2025
Est. primary completion date September 2, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age 16-65 years. 2. Hematologic malignancies intended for CAR-T therapy. 3. Expected survival time = 3 months (according to investigator's judgement). 4. Left ventricular ejection fractions = 55% by echocardiography. 5. ALT / AST <3 times of normal amounts. 6. Creatinine<2.0mg/dl. 7. PT and APPT <2 times of normal amounts. 8. Karnofsky performance status = 60. 9. The ECOG score =2 points. Exclusion Criteria: 1. Pregnant (or lactating) women; 2. Uncontrolled active infection; 3. Active infection of hepatitis B virus or hepatitis C virus; 4. Human immunodeficiency virus (HIV) positive; 5. 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; 6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Study Design


Locations

Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary gut microbiota diversity and composition of the gut microbiota From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion
Primary efficacy of CAR-T therapy CR,PR and NR six months
Primary toxicity of CAR-T therapy Adverse events are evaluated with CTCAE V5.0 six months
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