NCT03733249

Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Bellicum Pharmaceuticals · Industry
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Subjects enrolled on the BP-004 study who have completed or discontinued from the study, and are beyond Day 180 will be requested to enroll on this long-term follow up protocol. Long term follow up for gene therapy clinical and safety endpoints will continue up to 15 years.

Conditions

• Acute Lymphoblastic Leukemia
• Leukemia, Acute Myeloid (AML), Child
• Lymphoma, Non-Hodgkin
• Myelodysplastic Syndromes
• Primary Immunodeficiency
• Anemia, Aplastic
• Hemoglobinopathies
• Cytopenia
• Fanconi Anemia
• Diamond Blackfan Anemia
• Thalassemia
• Anemia, Sickle Cell

Interventions

Type	Name	Description
DRUG	Rimiducid	Rimiducid is administered to treat chronic graft versus host disease
BIOLOGICAL	rivogenlecleucel	donor T-cells modified with iCasp safety switch

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-06-30
• Completion: 2023-04-14
• First posted: 2018-11-07
• Last updated: 2023-09-26
• Results posted: 2023-09-26

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study