Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies

September 11, 2023 updated by: The First Affiliated Hospital of Soochow University

A Prospective and Observational Clinical Study of the Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies

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

Study Overview

Status

Recruiting

Conditions

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 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • the First Affiliated Hospital of Soochow University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hematological malignancies who were proposed for CAR-T treatment at the First Affiliated Hospital of Soochow University were enrolled in our study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Study Chair: Xiaowen Tang, PhD, the First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2023

Primary Completion (Estimated)

September 2, 2024

Study Completion (Estimated)

March 2, 2025

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gut microbiota + CAR-T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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