ClinicalTrials.gg
Enrolling by invitationNCT03391778Updated Aug 11, 2026

Adoptive Cell Therapy Long-term Follow-up (LTFU) Study

A Phase 1 interventional study of ADP adoptive cell therapy in Neoplasms, sponsored by USWM CT, LLC. Enrolling by invitation at 24 sites in 8 countries. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by USWM CT, LLC · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neoplasms

Browse trials for

Keywords

  • Long Term Follow Up
  • Adoptive Cell Therapy
  • Replication Competent Lentivirus
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 250 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

USWM CT, LLC is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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  • Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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.
  • 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 .

Exclusion criteria

Exclusion Criteria:

- None

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Participants receiving ADP adoptive cell therapy

    Biological: ADP adoptive cell therapy

Interventions

  • BiologicalADP adoptive cell therapy

    No study drug is administered in this study. Participants who received ADP adoptive cell therapy in a previous trial will be evaluated in this trial for long-term safety and efficacy.

06

What researchers measure

Primary outcomes

  1. Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)

    AEs will be collected.

    Time frame: 15 years post last treatment

Secondary outcomes

  1. Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples

    Peripheral blood samples will be collected for the assessment of VSV-G DNA copies.

    Time frame: 15 years

  2. Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.

    Peripheral blood samples will be collected for the assessment of WPRE or Psi DNA.

    Time frame: 15 years

  3. Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples

    Peripheral blood samples will be collected for the assessment of Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal).

    Time frame: 15 years

  4. Number of deaths

    Number of deaths will be summarized.

    Time frame: 15 years

  5. Time to death

    Time to death will be summarized.

    Time frame: 15 years

07

Study locations

24 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2018 (actual). Primary completion is estimated for Apr 2032, 167 months after the start.

Of 677 industry-sponsored phase 1 interventional studies under Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's planned 167 months is above that.

Counting every sponsor, half of 903 studies reached it within 40 months; a quarter within 23 and three quarters within 64.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2018
First posted
Jan 5, 2018
StartActual
Apr 9, 2018
Primary completionEst.
Apr 1, 2032
CompletionEst.
Apr 1, 2032
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03391778
Lead sponsor
USWM CT, LLC
Responsible party
Sponsor
First posted
Jan 5, 2018
Start date
Apr 9, 2018
Primary completion
Apr 1, 2032 (estimated)
Completion
Apr 1, 2032 (estimated)
Last update
Aug 11, 2026

Study contacts

Michael Nathenson, MD
study director · USWM CT, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion