A Phase 1 interventional study of GSK3901961 and Cyclophosphamide in Neoplasms, sponsored by Adaptimmune. Terminated at 21 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by Adaptimmune · Phase 1, Interventional, and Treatment
The primary purpose of this sub study is to assess the safety, tolerability and determine recommended Phase 2 dose (RP2D) of GSK3901961 in HLA A*02:01, HLA-A*02:05 and/or HLA A*02:06 positive participants with New York esophageal squamous cell carcinoma (NY ESO 1) and/or Cancer testis antigen 2 (LAGE 1a) positive previously treated metastatic Non-Small Cell Lung Cancer (NSCLC) and previously treated, advanced (metastatic or unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma SS/MRCLS.
This study is a substudy of the Master record - (209012) NCT04526509.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Adaptimmune is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive high dose of GSK3901961 after completing lymphodepleting chemotherapy. The first study participant receiving GSK3901961 will receive the total assigned dose as 2 separate infusions 7 days apart, in aliquots of 30% (first infusion) and 70% (second infusion) of the total target dose, respectively. Based on the dose limiting toxicities reported in the first participant, then all subsequent participants treated with GSK3901961 will receive the full dose as a single, i.e., one-time, infusion.
Drug: GSK3901961 · Drug: Cyclophosphamide · Drug: Fludarabine
GSK3901961 was administered.
Cyclophosphamide was administered as lymphodepleting chemotherapy.
Fludarabine was administered as lymphodepleting chemotherapy.
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT events were graded according to NCI-CTCAE v5.0. DLTs were defined as Grade (Gr) 4 (life-threatening and death) related to GSK3901961 2) Gr 3 (Severe or medically significant) at least possibly related to GSK3901961 and do not resolve to Gr \<=1 (or Baseline) within 7 days from the onset of the event 3) Gr \>=3 non-infectious pneumonitis not responding to oxygen supplementation and systemic steroid treatment 4) Any Gr 3 cytokine release syndrome (CRS) at least possibly related to GSK3901961 that does not improve to Gr \<2 (moderate) toxicity within 7 days with or without dexamethasone 5) Any Gr 4 CRS at least possibly related to study product that does not improve to Gr \<=2 (or Baseline) within 7 days 6) Any Gr 3 or greater neurotoxicity that does not resolve to Gr \<=2 within 72 hours 7) Any Gr \>=3 organ toxicity (exclusive of CRS toxicity) involving major organ systems that persists for \>72 hours and occurs within 28 days of infusion.
Time frame: Up to 28 days
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs Based on Maximum Severity
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above. AEs and SAEs were graded according to NCI-CTCAE v5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent. SAEs are subset of AEs. Results for maximum severity grades has been presented.
Time frame: Up to approximately 21 months
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI)
An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included events of Cytokine Release Syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus Host Disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), Guillain-Barre Syndrome (GBS), Pneumonitis and treatment-related inflammatory response at tumor site(s) and Neutropenia Grade 4 lasting more than or equal to 28 days. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent.
Time frame: Up to approximately 21 months
Overall Response Rate (ORR) Assessed by Investigator According to RECIST v1.1
Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response (CR) was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.
Time frame: Up to approximately 21 months
Duration of Response (DoR)
DoR is defined as the interval of time (in months) from first documented evidence of the confirmed response (PR or CR) as assessed by local investigators to the date of disease progression per RECIST v1.1 or death due to any cause, among participants with a confirmed response of PR or CR. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Time frame: Up to approximately 21 months
Maximum Transgene Expansion (Cmax) of GSK3901961
Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax.
Time frame: Up to 21 days
Time to Cmax (Tmax) of GSK3901961
Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax.
Time frame: Up to 21 days
Area Under the Time Curve From Zero to Time 28 Days AUC(0-28)
Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days).
Time frame: Up to 28 days
| Milestone | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | No Treatment |
|---|---|---|---|
| Started | 1 | 4 | 2 |
| Transferred to long-term follow-up study | 0 | 2 | 0 |
| Death post lymphodepletion | 0 | 2 | 0 |
| Completed | 0 | 4 | 0 |
| Not completed | 1 | 0 | 2 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Did not meet inclusion/exclusion criteria | 0 | 0 | 1 |
| Withdrew: Death prior to lymphodepletion | 0 | 0 | 1 |
DLT events were graded according to NCI-CTCAE v5.0. DLTs were defined as Grade (Gr) 4 (life-threatening and death) related to GSK3901961 2) Gr 3 (Severe or medically significant) at least possibly related to GSK3901961 and do not resolve to Gr \<=1 (or Baseline) within 7 days from the onset of the event 3) Gr \>=3 non-infectious pneumonitis not responding to oxygen supplementation and systemic steroid treatment 4) Any Gr 3 cytokine release syndrome (CRS) at least possibly related to GSK3901961 that does not improve to Gr \<2 (moderate) toxicity within 7 days with or without dexamethasone 5) Any Gr 4 CRS at least possibly related to study product that does not improve to Gr \<=2 (or Baseline) within 7 days 6) Any Gr 3 or greater neurotoxicity that does not resolve to Gr \<=2 within 72 hours 7) Any Gr \>=3 organ toxicity (exclusive of CRS toxicity) involving major organ systems that persists for \>72 hours and occurs within 28 days of infusion.
| Participants | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | 1 | 1 |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above. AEs and SAEs were graded according to NCI-CTCAE v5.0. Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences; Grade 5- Death related to AE. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent. SAEs are subset of AEs. Results for maximum severity grades has been presented.
| Participants | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
|---|---|---|
| AEs, Grade 1 | 0 | 0 |
| AEs, Grade 2 | 0 | 0 |
| AEs, Grade 3 | 0 | 0 |
| AEs, Grade 4 | 1 | 3 |
| AEs, Grade 5 | 0 | 1 |
| SAEs, Grade 1 | 0 | 1 |
| SAEs, Grade 2 | 0 | 0 |
| SAEs, Grade 3 | 1 | 0 |
| SAEs, Grade 4 | 0 | 0 |
| SAEs, Grade 5 | 0 | 1 |
An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included events of Cytokine Release Syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus Host Disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), Guillain-Barre Syndrome (GBS), Pneumonitis and treatment-related inflammatory response at tumor site(s) and Neutropenia Grade 4 lasting more than or equal to 28 days. AEs which start or worsen on or after T-cell infusion are classified as treatment emergent.
| Participants | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
|---|---|---|
| Participants with any AESI | 1 | 4 |
| Cytokine Release Syndrome (CRS) | 1 | 3 |
| Graft versus host disease | 1 | 0 |
| Haematopoietic cytopenias (including pancytopenia and aplastic anaemia) | 1 | 4 |
| Immune Effector-Cell Associated Neurotoxicity Syndrome | 0 | 1 |
Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 relative to the total number of participants in the analysis population. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response (CR) was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.
| percentage of participants | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
|---|---|---|
| Overall Response Rate (ORR) Assessed by Investigator According to RECIST v1.1 | 100 (2.5 to 100) | 50 (6.8 to 93.2) |
DoR is defined as the interval of time (in months) from first documented evidence of the confirmed response (PR or CR) as assessed by local investigators to the date of disease progression per RECIST v1.1 or death due to any cause, among participants with a confirmed response of PR or CR. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
| Months | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
|---|---|---|
| Duration of Response (DoR) | 1.22 (NA to NA) | 2.96 (2.8 to 3.1) |
Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax.
| Copies per microgram genomic DNA | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
|---|---|---|
| Maximum Transgene Expansion (Cmax) of GSK3901961 | 121973 ± NA | 29058.02 ± 401.296 |
Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax.
| days | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
|---|---|---|
| Time to Cmax (Tmax) of GSK3901961 | 21 (NA to NA) | 7.5 (1 to 20) |
Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days).
| Days*copies per microgram genomic DNA | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells |
|---|---|---|
| Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) | 2267635.372 ± NA | 374639.00 ± 371.441 |
Collected over All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 21 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | 2/4 (50%) | 2/4 (50%) | 4/4 (100%) |
| No Treatment | 1/2 (50%) | 2/2 (100%) | 1/2 (50%) |
| Event | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | No Treatment |
|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 1/1 | 0/4 | 0/2 |
| Non-cardiac chest painGeneral disorders | 1/1 | 0/4 | 0/2 |
| PyrexiaGeneral disorders | 1/1 | 0/4 | 0/2 |
| Graft versus host disease in skinImmune system disorders | 1/1 | 0/4 | 0/2 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/1 | 0/4 | 0/2 |
| Atrial fibrillationCardiac disorders | 0/1 | 0/4 | 1/2 |
| Pericardial effusionCardiac disorders | 0/1 | 0/4 | 1/2 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 0/1 | 0/4 | 1/2 |
| Pulmonary haemorrhageRespiratory, thoracic and mediastinal disorders | 0/1 | 1/4 | 0/2 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/1 | 1/4 | 0/2 |
| Event | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | No Treatment |
|---|---|---|---|
| COVID-19Infections and infestations | 1/1 | 2/4 | 1/2 |
| Staphylococcal skin infectionInfections and infestations | 1/1 | 0/4 | 0/2 |
| AnaemiaBlood and lymphatic system disorders | 1/1 | 2/4 | 1/2 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/1 | 2/4 | 0/2 |
| NauseaGastrointestinal disorders | 1/1 | 3/4 | 0/2 |
| Abdominal painGastrointestinal disorders | 1/1 | 0/4 | 0/2 |
| Lower gastrointestinal haemorrhageGastrointestinal disorders | 1/1 | 0/4 | 0/2 |
| VomitingGastrointestinal disorders | 1/1 | 0/4 | 0/2 |
| FatigueGeneral disorders | 1/1 | 1/4 | 1/2 |
| Non-cardiac chest painGeneral disorders | 1/1 | 1/4 | 0/2 |
| Age, Continuous(years) | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | No Treatment | Total |
|---|---|---|---|---|
| Mean | 27 | 51.5 ± 17.79 | 43.0 ± 0.00 | 45.6 ± 15.53 |
| Age, Customized(Participants) | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | No Treatment | Total |
|---|---|---|---|---|
| Age, customized — 19-64 | 1 | 3 | 2 | 6 |
| Age, customized — >=65 | 0 | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | No Treatment | Total |
|---|---|---|---|---|
| Female | 1 | 1 | 1 | 3 |
| Male | 0 | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | No Treatment | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 4 | 2 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | No Treatment | Total |
|---|---|---|---|---|
| White | 1 | 4 | 2 | 7 |
| Region of Enrollment(participants) | GSK3901961 1 × 10^9 - 8 × 10^9 Transduced Cells | GSK3901961 0.1 × 10^9 - 0.8 × 10^9 Transduced Cells | No Treatment | Total |
|---|---|---|---|---|
| Australia | 0 | 1 | 0 | 1 |
| Germany | 0 | 2 | 1 | 3 |
| Sweden | 0 | 1 | 0 | 1 |
| United States | 1 | 0 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk.com
Ran from Mar 2021 to primary completion in Jun 2023, 26 months.
Results were first posted in May 2024, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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