NCT06041815

Unknown

Correlation Between Gut Microbiota and Clinical Response to ...

The First Affiliated Hospital of Soochow University Source

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Other study identifiers

Sponsor study identifier

gut microbiota + CAR-T

Study Type

observational

Estimated enrollment

100

Locations

1 country

Sites

1

Timeline

Study Start

September 3, 2023

Actual (reported)

Primary Completion

September 2, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 100 participants
Study completion date: March 2, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 3, 2023
Actual (reported)
First Submitted
September 11, 2023
Actual (reported)
First Posted
September 18, 2023
Actual (reported)
Primary Completion
September 2, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: September 18, 2023
Status Verified: September 2023
Last Update Submitted: September 11, 2023

Conditions

Chimeric Antigen Receptor T-cell Therapy Hematological Malignancies

Keywords

gut microbiota, CAR-T

Outcome Measures

Primary Outcomes (3)

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

Eligibility Criteria

Age16 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Age 16-65 years.

Sponsors & Collaborators

The First Affiliated Hospital of Soochow University
Otherlead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Xiaowen Tang, PhDCONTACT+8651267781525 xwtang1020@163.com

Depei Wu, PhDCONTACT+8651267781856 wudepei@163.com

Biospecimen

Retention: SAMPLES WITH DNA

feces

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

Xiaowen Tang, PhD
The First Affiliated Hospital of Soochow University
STUDY CHAIR

Central Study Contacts

Xiaowen Tang, PhD

CONTACT

86-512-67781525 xwtang1020@163.com

Depei Wu, PhD

CONTACT

86-512-67781856

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

September 3, 2023

Actual (reported)

Primary Completion

September 2, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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Early Phase 1Not Yet Recruiting

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Phase 2Completed

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RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies

Early Phase 1Completed

NCT07035938

T-cell Developmental Status in Patients With Malignant Hematological Tumors

Recruiting

NCT07122674

18F-Pentixafor PET in Hematologic Malignancies

Recruiting

Hematologic malignancies intended for CAR-T therapy.

Expected survival time ≥ 3 months (according to investigator's judgement).

Left ventricular ejection fractions ≥ 55% by echocardiography.

ALT / AST \<3 times of normal amounts.

Creatinine\<2.0mg/dl.

PT and APPT \<2 times of normal amounts.

Karnofsky performance status ≥ 60.

The ECOG score ≤2 points.

You may not qualify if:

Pregnant (or lactating) women;
Uncontrolled active infection；
Active infection of hepatitis B virus or hepatitis C virus；
Human immunodeficiency virus (HIV) positive；
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；
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Contact the study team to confirm eligibility.

wudepei@163.com

Study Completion

March 2, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

September 18, 2023

Record last verified: 2023-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06041815
Data provider: ClinicalTrials.gov
Source updated: 2023-09-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:58 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations