Brief Summary
This trial will evaluate long term safety of participants who have received AdaptImmune (ADP) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.
Brief Title
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
Detailed Description
Participants who received a ADP adoptive cell therapy will be enrolled in this non-therapeutic, multi-center, long term follow-up (LTFU) study and will be followed for up to 15 years post-infusion of lentiviral vector-based adoptive cell therapy. Participants will be monitored for safety following last adoptive cell therapy infusion.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
215-825-9260
Central Contact Email
patients@adaptimmune.com
Completion Date
Completion Date Type
Estimated
Conditions
Neoplasms
Eligibility Criteria
Inclusion Criteria:
* Participants who have received at least one dose of ADP adoptive cell therapy agent.
* Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.
* Participants who have completed treatment as part of managed access to a GSK adoptive cell therapy.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* The investigator is responsible for review of medical history.
* Capable of giving signed informed consent.
Exclusion Criteria:
- None
* Participants who have received at least one dose of ADP adoptive cell therapy agent.
* Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.
* Participants who have completed treatment as part of managed access to a GSK adoptive cell therapy.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* The investigator is responsible for review of medical history.
* Capable of giving signed informed consent.
Exclusion Criteria:
- None
Inclusion Criteria
Inclusion Criteria:
* Participants who have received at least one dose of ADP adoptive cell therapy agent.
* Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.
* Participants who have completed treatment as part of managed access to a GSK adoptive cell therapy.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* The investigator is responsible for review of medical history.
* Capable of giving signed informed consent.
* Participants who have received at least one dose of ADP adoptive cell therapy agent.
* Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.
* Participants who have completed treatment as part of managed access to a GSK adoptive cell therapy.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* The investigator is responsible for review of medical history.
* Capable of giving signed informed consent.
Gender
All
Gender Based
false
Keywords
Long Term Follow Up
Adoptive Cell Therapy
Replication Competent Lentivirus
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT03391778
Org Class
Industry
Org Full Name
Adaptimmune
Org Study Id
208750
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Long-Term Follow-Up (LTFU) of Participants Treated With ADP Adoptive Cell Therapies
Primary Outcomes
Outcome Description
AEs will be collected.
Outcome Measure
Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)
Outcome Time Frame
15 years post last treatment
Secondary Ids
Secondary Id
ADP-0000-002
Secondary Outcomes
Outcome Description
Peripheral blood samples will be collected for the assessment of VSV-G DNA copies.
Outcome Time Frame
15 years
Outcome Measure
Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples
Outcome Description
Peripheral blood samples will be collected for the assessment of WPRE or Psi DNA.
Outcome Time Frame
15 years
Outcome Measure
Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.
Outcome Description
Peripheral blood samples will be collected for the assessment of Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal).
Outcome Time Frame
15 years
Outcome Measure
Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples
Outcome Description
Number of deaths will be summarized.
Outcome Time Frame
15 years
Outcome Measure
Number of deaths
Outcome Description
Time to death will be summarized.
Outcome Time Frame
15 years
Outcome Measure
Time to death
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Loeb
Investigator Email
david.loeb@einsteinmed.org
Investigator Phone
718-741-2342