Follow-up of Phase 1/2 Study of CaspaCIDe T Cells (BPX-501) From an HLA-partially Matched Family Donor After Negative Selection of TCR αβ+T Cells in Pediatric Patients Affected by Hematological Disorders

Locations

1 Italy site

1 Saudi Arabia site

Age

1 to 18 Years

Phase

Phase 1/Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Biological

Compensation

Unknown

About the study

This is a long-term follow up study evaluating the safety of BPX-501 T cells
(rivogenlecleucel) and infused in pediatric patients previously enrolled on the BP-004 study.

participation requirements

– Signed written informed consent by the patient or the patient’s guardian for children
who are minors

– Enrolled on BP-004 protocol, received BPX-501 infusion, completed or discontinued from
the study, and are beyond Day +180.

participation restrictions

– Lack of parents’/guardian’s informed consent for children who are minors

– Loss of allograft prior to 6 months

Locations

  • Rome, Italy, IRCCS Ospedale Pediatrico Bambino Gesù, 00161
  • Riyadh, Saudi Arabia, King Abdullah International Medical Research Center (KAIMRC), 11426