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

A

Adaptimmune

Status and phase

Enrolling
Phase 1

Conditions

Neoplasms

Treatments

Biological: ADP adoptive cell therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT03391778
208750
ADP-0000-002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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  • Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

250 participants in 1 patient group

Participants receiving ADP adoptive cell therapy
Experimental group
Treatment:
Biological: ADP adoptive cell therapy

Trial contacts and locations

24

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Central trial contact

Adaptimmune Patient Enquiries Call Center

Data sourced from clinicaltrials.gov

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