Actively Recruiting

Age: 18Years - 70Years
All Genders
ID04892433

Tissue Study in Patients Undergoing CAR-T Cell Therapy Observational Study on Biological Markers and Immune Response in Blood Cancer Patients Receiving CAR-T Therapy

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-27

150

Participants Needed

1

Research Sites

254 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying a new type of cancer treatment called CAR-T immunotherapy, which uses specially modified T cells to target and destroy cancer cells. This therapy is for patients with certain blood cancers that have not responded to other treatments, including forms of lymphoma, leukemia, and multiple myeloma. CAR-T therapy gives patients reprogrammed immune cells that can better recognize and attack cancer, overcoming some limitations of the body's natural immune responses. The study focuses on analyzing blood samples from patients undergoing CAR-T therapy at multiple time points before and after treatment, up to one year later. Researchers will examine epigenetic changes, microRNA levels, and different immune cell populations to understand how these factors relate to patient outcomes. The study will include about 35 patients per year over five years and will use samples collected during routine clinical care. Participants will provide peripheral blood samples at various stages, including before apheresis, on treatment day, and multiple days post-infusion. The research aims to link biological markers with clinical results to better understand and manage complications like inflammatory responses and neurological effects. This may help improve how CAR-T therapy is personalized and its safety monitored in patients with advanced blood cancers.

CONDITIONS

Official Title

Tissue Study in Patients Undergoing CAR-T Cell Therapy (CAR_21_01)

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Patients with hematological disease scheduled for CAR-T therapy at the Advanced Cell Therapy Program, IRCCS University Hospital of Bologna
  • Patients who have signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCC, University Hospital of Bologna

Bologna, Italy, Italy, 40138

Actively Recruiting

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Research Team

F

Franscesca Bonifazi, MD

E

Enrica Tomassini, DM

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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Published Research Related To This Trial

Peripheral blood cellular profile at pre-lymphodepletion is associated with CD19-targeted CAR-T cell-associated neurotoxicity.

Serena De Matteis, Michele Dicataldo, Beatrice Casadei...

https://pubmed.ncbi.nlm.nih.gov/36726971