Adoptive cell therapy LTFU study

Phase 1

• Conditions: Synovial sarcomaMultiple myelomaNon-small cell lung cancerMyxoid liposarcoma; MedDRA version: 20.0Level: PTClassification code 10042863Term: Synovial sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10073137Term: Myxoid liposarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004888-31-NL
• Lead Sponsor: GlaxoSmithKline research & development Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-25
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

Type of Participant and Disease Characteristics
1. Participants who:
a. Have received at least one infusion of a GSK adoptive cell therapy
b. Have completed a GSK sponsored or suported interventional study or have withdrawn from it, as defined in the interventional protocol
c. have completed treatment as part of managed access to a GSK adoptive cell therapy
Participants who complete an interventional study will complete the assessments
outlined in the interventional protocol prior to starting on this study.
Sex
2. Male or Female participants. Contraceptive use by men or women should be
consistent with local regulations regarding the methods of contraception for those
participating in clinical studies.
a. Male Participants:
Male participants are eligible to participate if they agree to the following contraception guidelines, starting at the first dose of chemotherapy and for at least 12 months after receiving the cell therapy infusion, or until
the participants' persistence of gene modified cells is below the level of detection for 2 consecutive assessments, whichever is longer. If participants have received pembrolizumab during the interventional
study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells.
- Refrain from donating sperm
PLUS either:
- Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
OR
- Must agree to use contraception/barrier as detailed below
o Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
o Agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person
b. Female Participants:
A female participant is eligible to participate if at least one of the following
conditions applies:
- Is not a woman of childbearing potential (WOCBP) as defined in Section 10.4.1 of the protocol
OR
- Is a WOCBP (as defined in Section 10.4.1) who will agree to use a barrier method
(male condom) and use a contraceptive method that is highly effective (with a
failure rate of <1% per year), as described in Section 10.4.2 for at least 12 months after receiving the T-cell infusion, or until the participants' persistence of gene modified cells is below the level of detection for 2 consecutive assessments, whichever is longer.
If WOCBP participants have received pembrolizumab during the interventional study, they must use effective contraception for at least 4 months after the last dose of pembrolizumab if this time frame is longer than the duration of contraception required in the context of chemotherapy and gene modified cells. WOCBP should also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method.
- Additional requirements for pregnancy testing are located in Appendix 2
- The investigator is responsible for review of medical history, menstrual history,
and recent sexual activity to decrease the risk for inclusion in the interventional
study of a woman with an early undetecte

Exclusion Criteria

Not applicable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified