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

Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041815
• Other study ID #: gut microbiota + CAR-T
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms

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