Long-term safety follow-up for people previously in CAR-T gene therapy studies
Checks long-term health of people with blood cancers after earlier CAR-T gene therapy.
Key facts
- Who runs it
- National Cancer Institute (NCI)
- Where
- Bethesda, United StatesSee the site
- Trial code
- Registry title
- Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies
- Status
- Enrolling by invitation
- People taking part
- 1,000 people, planned
- Started
- 24 Sept 2015
- Expected to end
- 1 Aug 2050
- Type of study
- Observational
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who were treated in an earlier CAR T-cell gene therapy study. It only follows their health over time and gives no treatment.
- Age
- 18 years and older
- Sex
- All sexes can join
- Earlier treatment
- Must have received treatment in a CAR T-cell gene therapy study.
The registry criteria, word for word
Show all 2 criteriaShow less
Other criteria
- INCLUSION CRITERIA:
- Subjects who have received treatment on a CAR T-cell gene therapy protocol. Age >= 18 years as children are generally excluded from CAR T-cell gene therapy studies
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesNo longer taking part
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
- Gene therapy is a way to treat or prevent disease using genes. It is monitored very closely by regulators because there can be long-term, unexpected side effects. NIH is required to try to contact people who have been treated with gene therapy at least annually for up to 15 years. This is to see if they have had any bad side effects. This trial does not include any therapy and is only for patients previously treated on gene-therapy trials at the NCI Surgery Branch who are no longer enrolled on their original gene therapy clinical trial.
Objective:
- To collect of long-term follow-up data on people who have been in gene transfer studies. This follow-up is required by regulators.
Eligibility:
- People age 18 and older who have been in a previous NCI Surgery Branch gene therapy research study.
Design:
* After they get the genetically modified cells, participants will: * Have blood drawn 3, 6, and 12 months later. * Have an annual clinic visit for the next 4 years. They will have a physical exam. They will answer questions about any signs of neurological, autoimmune, or blood disorders, or any new cancers. Blood may be drawn. * Be called or emailed annually for the next 10 years. They will answer health questions. Blood samples may need to be taken. * Participants will be asked for their current address and phone number. They will also be asked for the address and phone number of 1 or 2 people who will know their whereabouts. One of these should be a family member if possible, * At the time of the participant s death, researchers will request permission from their family for an autopsy.
The group in the trial
- 1/Cohort 1
Subjects who have received treatment on an NCI Surgery Branch CAR T-cell gene therapy protocols.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Gene Therapy Follow up Protocol for Subjects Previously Enrolled in CAR T-Cell Studies
- Plain-language title
- Long-term safety follow-up for people previously in CAR-T gene therapy studiesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026