Hematological MalignanciesNCT06041815
Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
An observational study of Hematological Malignancies and Chimeric Antigen Receptor T-cell Therapy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Hematological Malignancies, Chimeric Antigen Receptor T-cell Therapy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2023to 2 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Age 16-65 years.
- 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.
Show all 9Show fewer
- PT and APPT <2 times of normal amounts.
- Karnofsky performance status ≥ 60.
- The ECOG score ≤2 points.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaowen Tang, PhD, +8651267781525, xwtang1020@163.com
Depei Wu, PhD, +8651267781856, wudepei@163.com
About this study
Official title: A Prospective and Observational Clinical Study of the Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
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
Read the 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.
- Keywords
- gut microbiota, CAR-T
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota
diversity and composition of the gut microbiota
Measured: From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion
efficacy of CAR-T therapy
CR，PR and NR
Measured: six months
toxicity of CAR-T therapy
Adverse events are evaluated with CTCAE V5.0
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start3 Sep 2023
- Primary completion2 Sep 2024 (estimated)
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaowen Tang, PhD, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041815
- Sponsor's protocol ID
- gut microbiota + CAR-T
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Observational Clinical Study of the Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
- ClinicalTrials.gov ID
- NCT06041815
- Acronym / sponsor ID
- gut microbiota + CAR-T
- Keywords
- gut microbiota, CAR-T
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 2 Sep 2024 (estimated)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Age 16-65 years.
- 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.
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gut microbiota
Time frame: From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion
diversity and composition of the gut microbiota
efficacy of CAR-T therapy
Time frame: six months
CR，PR and NR
toxicity of CAR-T therapy
Time frame: six months
Adverse events are evaluated with CTCAE V5.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaowen Tang, PhD study chair
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancies and Chimeric Antigen Receptor T-cell Therapy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaowen Tang, PhD (86-512-67781525, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiota (time frame: From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.