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

Last updated: September 11, 2023
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematologic Neoplasms

Neoplasms

Hematological Disorders

Treatment

N/A

Clinical Study ID

NCT06041815
gut microbiota + CAR-T
  • Ages 16-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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 sixmonths or those with class III or IV cardiac function according to the New Yorkclassification；
  6. Any situations that the investigator believes may increase the risk of patients orinterfere with the results of study.

Study Design

Total Participants: 100
Study Start date:
September 03, 2023
Estimated Completion Date:
March 02, 2025

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

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