Multi-omic profiling of children and adults receiving bone marrow transplant or CAR‑T therapy
Multi-omic Characterization of Pediatric and Adult Patients Undergoing Hematopoietic Stem Cell Transplantation and Advanced Cell Therapies
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT07464483 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, Bologna
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.