E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Synovial sarcoma, Non-small cell lung cancer (NSCLC), Myxoid/round cell liposarcoma (MRCLS), Multiple Myeloma & other indications |
|
E.1.1.1 | Medical condition in easily understood language |
Synovial sarcoma, Non-small cell lung cancer (NSCLC), Myxoid/round cell liposarcoma (MRCLS),Multiple Myeloma & other indications |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042863 |
E.1.2 | Term | Synovial sarcoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10073137 |
E.1.2 | Term | Myxoid liposarcoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To monitor participants for delayed AEs associated with administration of autologous cells that have been genetically modified |
|
E.2.2 | Secondary objectives of the trial |
- To monitor Replication Competent Lentivirus (RCL)
- To measure persistence of genetically modified T 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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Type of Participant and Disease Characteristics
1. Participants who:
a. Have received at least one infusion of a GSK adoptive cell therapy agent and
b. Have completed a GSK sponsored or supported interventional study or have withdrawn from it, as defined by the interventional protocol or
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
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.
- 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 undetected pregnancy
Informed Consent
3. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. The informed consent form to participate in the LTFU study will be collected prior to entry into this LTFU study. For participants <18 years of age (or the legal minimum age in the relevant country) their legal guardian must give informed consent. Pediatric participants will be included in age-approximate discussion in order to obtain assent as per local requirements. |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
AEs/SAEs 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 hematologic disorder
- New incidence of infection (potentially related to gene modified cell therapy)
- Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy |
|
E.5.1.1 | 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) |
|
E.5.2 | 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 |
|
E.5.2.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Long-Term Follow-Up (LTFU) of Participants Treated with GSK Adoptive Cell Therapies |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
United States |
France |
Germany |
Italy |
Netherlands |
Spain |
Sweden |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 15 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 15 |