NeoplasmsPhase 1NCT03391778
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
A Phase 1 study testing ADP adoptive cell therapy in people with Neoplasms, run by USWM CT, LLC at 24 sites in 8 countries.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms
- What is being tested?
- ADP adoptive cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 24 sitesin 8 countries
- Study dates
- 9 Apr 2018to 1 Apr 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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- Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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.
Who cannot join
- None
Trial locations and contacts
24 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 8 countries
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30322
ADP Investigational Site
Baltimore, Maryland, 21201
National Cancer Institute - Center for Cancer Research
Bethesda, Maryland, 20892
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Froedtert Hospital
Milwaukee, Wisconsin, 53226
Memorial Sloan Kettering Cancer Center - New York
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Oregon Health and Science University
Portland, Oregon, 97239
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
United Kingdom3 sites
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
USWM CT Investigational Site
Manchester, M20 4BX
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Canada2 sites
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Germany2 sites
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937
Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81377
Italy1 site
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
About this study
Official title: Long-Term Follow-Up (LTFU) of Participants Treated With ADP Adoptive Cell Therapies
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.
- Conditions
- Neoplasms
- Being tested
- ADP adoptive cell therapy
- Keywords
- Long Term Follow Up, Adoptive Cell Therapy, Replication Competent Lentivirus
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADP adoptive cell therapyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving ADP adoptive cell therapy | Experimental | Not described Receives: Biological: ADP adoptive cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)
AEs will be collected.
Measured: 15 years post last treatment
Secondary outcomes (5)
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.
Measured: 15 years
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.
Measured: 15 years
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).
Measured: 15 years
Number of deaths
Number of deaths will be summarized.
Measured: 15 years
Time to death
Time to death will be summarized.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start9 Apr 2018
- Primary completion1 Apr 2032 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USWM CT, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Nathenson, MD, Study director, USWM CT, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391778
- Sponsor's protocol ID
- 208750
- Other IDs
- ADP-0000-002
- Status last verified
- Feb 2026
- First submitted
- 2 Jan 2018
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up (LTFU) of Participants Treated With ADP Adoptive Cell Therapies
- ClinicalTrials.gov ID
- NCT03391778
- Acronym / sponsor ID
- 208750
- Conditions
- Neoplasms
- Keywords
- Long Term Follow Up, Adoptive Cell Therapy, Replication Competent Lentivirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- USWM CT, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 1 Apr 2032 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving ADP adoptive cell therapy | Experimental | Biological: ADP adoptive cell therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADP adoptive cell therapyNo 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. | Biological | Participants receiving ADP adoptive cell therapy |
Primary outcome
Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)
Time frame: 15 years post last treatment
AEs will be collected.
5 secondary outcomes
Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples
Time frame: 15 years
Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.
Time frame: 15 years
Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples
Time frame: 15 years
Number of deaths
Time frame: 15 years
Time to death
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Nathenson, MD study director
USWM CT, LLC
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADP adoptive cell therapy in people with Neoplasms, run by USWM CT, LLC at 24 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, United Kingdom, Canada, Germany, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs) (time frame: 15 years post last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.