Clinical trial · Observational
Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
A Prospective and Observational Clinical Study of the Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
NCT06041815CI-TRIAL-00069687unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chimeric Antigen Receptor T-cell Therapy | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- gut microbiota
- timeFrame
- From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion
- description
- diversity and composition of the gut microbiota
- measure
- efficacy of CAR-T therapy
- timeFrame
- six months
- description
- CR，PR and NR
- measure
- toxicity of CAR-T therapy
- timeFrame
- six months
- description
- Adverse events are evaluated with CTCAE V5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.