Examining the link between gut bacteria and response to CAR-T therapy for blood cancers

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

This study is trying to see if the bacteria in the gut can help predict how well CAR-T therapy works for people with blood cancers.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: CAR-T, Chimeric antigen receptor
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06041815 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between gut microbiota and the clinical response to Chimeric Antigen Receptor T-cell (CAR-T) therapy in patients with hematological malignancies. By evaluating the gut microbiota composition, the study seeks to identify potential biomarkers that could predict treatment efficacy and associated toxicities. The research is motivated by previous findings that suggest gut microbiota may influence the effectiveness of T cell-driven cancer immunotherapies. Participants will be monitored for their clinical responses to CAR-T therapy while their gut microbiota profiles are analyzed.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16-65 with hematological malignancies who are eligible for CAR-T therapy.

Not a fit: Patients with uncontrolled infections, active hepatitis, or significant cardiac issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized CAR-T therapies based on gut microbiota profiles, improving treatment outcomes for patients.

How similar studies have performed: While there have been studies linking gut microbiota to immunotherapy responses, this specific correlation with CAR-T therapy remains novel and untested.

Eligibility criteria

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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xiaowen Tang, PhD

Conditions Hematological Malignancies; Chimeric Antigen Receptor T-cell Therapy; gut microbiota, CAR-T