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

Recruiting

• Conditions: Chimeric Antigen Receptor T-cell Therapy; Hematological Malignancies

• Registration Number: NCT06041815
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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 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 Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-03
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-11
• Last Update Submitted: 2023-09-11
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-09-02
• Study Completion: 2025-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China