Multi-omic profiling of children and adults receiving bone marrow transplant or CAR‑T therapy
Official title: Multi-omic Characterization of Pediatric and Adult Patients Undergoing Hematopoietic Stem Cell Transplantation and Advanced Cell Therapies
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07464483 · Data updated 2026-11-12
This project will test whether analyzing the gut microbiome and other biological samples before and after bone marrow transplant or CAR‑T therapy in children and adults can help predict complications and recovery.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | November 21, 2025 |
| Main results expected | July 21, 2028 |
| Study ends | November 21, 2028 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07464483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric or adult patients scheduled to receive allogeneic hematopoietic stem cell transplantation or CAR‑T infusion who can provide informed consent and biological samples.
✕Probably not a fit
Patients not undergoing allogeneic HCT or CAR‑T, those unwilling to provide serial biological samples, or those unable to attend follow‑up visits are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single‑center effort will collect stool, urine, serum, saliva, and available biopsy specimens from pediatric and adult patients undergoing allogeneic hematopoietic stem cell transplantation or CAR‑T infusion. Samples will be analyzed using multi‑omic approaches (microbiome sequencing, metabolomics, host immune profiling, and histology) at multiple time points before and after therapy. Researchers will correlate molecular signatures with clinical outcomes such as graft‑versus‑host disease, infections, relapse, immune reconstitution, and treatment‑related toxicities. The goal is to identify biomarkers that could inform personalized prevention and management strategies.
Why it matters
Potential benefit: If successful, the findings could help identify biomarkers to predict and prevent complications like graft‑versus‑host disease, severe infections, and delayed immune recovery.
How similar studies have gone: Previous adult studies have linked reduced gut microbial diversity and pathogen domination with worse post‑transplant outcomes, but comprehensive pediatric‑to‑adult multi‑omic characterization across HCT and CAR‑T is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Allogeneic Hematopoietic Stem Cell Transplantation or CAR-T infusion for any indication * Obtaining informed consent from parents/guardians/legal representatives or from the patient Exclusion Criteria: -none
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy Recruiting
Study contacts
- Study coordinator: Riccardo Masetti, MD
- Email: riccardo.masetti@aosp.bo.it
- Phone: +39051-2144016
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.