Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Rimiducid and Rivogenlecleucel Rimiducid: to treat uncontrolled GVHD in patients who have received rivogenlecleucel Rimiducid will be given at 0.4 mg/kg weight (intravenous infusion) No further rivogenlecleucel infusions are planned. Patients who received rivogenlecleucel in the BP-004 study will be evaluated for long-term safety and efficacy. |
Drug: Rimiducid
Rimiducid is administered to treat chronic graft versus host disease
Other Names:
Biological: rivogenlecleucel
donor T-cells modified with iCasp safety switch
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Survival [two years after rivogenlecleucel infusion]
Incidence of disease free survival at 2 years
Secondary Outcome Measures
- Adverse events [Up to 15 years after rivogenlecleucel infusion]
Incidence of delayed adverse events suspected to be related to rivogenlecleucel or rimiducid
- Rimiducid Pharmacokinetics [Up to 15 years after rivogenlecleucel infusion]
Assessment of PK (rimiducid) and PD (BPX-501) profiles after treatment with rimiducid for aGVHD.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
Lack of parents'/guardian's informed consent for children who are minors
-
Loss of allograft prior to 6 months
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | IRCCS Ospedale Pediatrico Bambino Gesù | Rome | Italy | 00161 |
Sponsors and Collaborators
- Bellicum Pharmaceuticals
Investigators
- Study Director: Bellicum Pharmaceuticals, Bellicum Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BP-404