Synovial sarcoma Multiple myeloma Non-small cell lung cancer Myxoid liposarcoma MedDRA version: 20.0 Level: PT Classification code 10042863 Term: Synovial sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classificat
Conditions
Sponsors
GlaxoSmithKline research & development Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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one infusion of a GSK adoptive cell therapy b. Have completed a GSK sponsored or suported interventional study or have withdrawn from it, as defined in the interventional protocol c. have completed treatment as part of managed access to a GSK adoptive cell therapy Participants who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
Exclusion criteria: Not applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To monitor participants for delayed AEs associated with administration of autologous cells that have been genetically modified by lentiviral vectors;Secondary Objective: - To monitor Replication Competent Lentivirus (RCL) - To measure persistence of genetically modified cells in the body - Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by polymerase chain reaction (PCR) - To monitor survival status;Primary end point(s): (S)AEs to be reported: - New malignancies - New incidence or exacerbation of a pre-existing neurologic disorder - New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder - New incidence of immune-related hematologic disorder - New incidence of infection (potentially related to gene modified cell therapy) - Serious infections (including opportunistic) - Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy;Timepoint(s) of evaluation of this end point: Year 1(3, 6 and 12 months), Year 2(18, 24 months), Year 3 (30 and 36 months), Year 4 (42, 48 months), Year 5 (54, 60 months) and Year 6-15 (annually) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Vesicular Stomatitis Virus G protein (VSV-G) DNA copies in peripheral blood samples - Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples - Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) identified in peripheral blood - Incidence of death and time to death;Timepoint(s) of evaluation of this end point: VSV-G: Year 1 (3, 6 and 12 months), Year 2 (24 months), Year 3 (36 months), Year 4 (48 months), Year 5 (60 months) and Year 6-15 (annually) Persistence and Integration: Year 1(3, 6 and 12 months), Year 2(18, 24 months), Year 3 (30 and 36 months), Year 4 (42, 48 months), Year 5 (54, 60 months) and Year 6-15 (annually) Survival Status: Year 1 (3, 6 and 12 months), Year 2 (24 months), Year 3 (36 months), Year 4 (48 months), Year 5 (60 months) and Year 6-15 (annually) | — |
Countries
Australia, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed