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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2033210463 | Registry Identifier | jRCT |
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Business decision unrelated to patient safety
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In this study, people with mesothelin-expressing advanced or metastatic solid tumors will receive TAK-103 with their white blood cells. The main aims of this study are to check if the participants get any side effects from treatment with TAK-103 and to check how much TAK-103 participants can receive without getting side effects from it. Researchers can then work out the best dose of TAK-103 to give to participants in future studies.
At the first visit, the study doctor will check who can take part. For those who can take part, the study doctors will collect white blood cells from each participant. These cells are sent to the laboratory where TAK-103 is added to each participant's cells. This can take up to 4 or 5 weeks. Participants may receive specific treatments while participants are waiting for TAK-103. Then, participants will receive TAK-103 with their cells slowly through a vein (infusion). Participants will receive lower to higher doses of TAK-103. Each participant will just receive 1 dose. The study doctors will check for side effects after each different dose of TAK-103. In this way, researchers can work out the best dose of TAK-103 to give to participants in future studies.
Participants will stay in hospital for 28 days or longer for their treatment. Then, participants will visit the clinic for regular check-ups for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-103, Dose Escalation | Experimental | TAK-103, Chimeric antigen receptor (CAR) (+) cells, intravenous infusion, will be administered at approximately 5 mL/min. There are 5 planned dose levels: 1x10^6, 3x10^6, 1x10^7, 1x10^8 and 5x10^8 CAR (+) cells/body. The level of dose in dose escalation will be guided by dose escalation schema based on the observed dose limiting toxicities (DLT) rate at each dose level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-103 | Biological | TAK-103 intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Any Grade 3 or higher toxicities that were considered by the investigator to be at least possibly related to therapy with TAK-103 during the 28 days immediately after infusion of TAK-103 and, any adverse events (AEs) requiring endotracheal intubation or tracheostomy were considered as DLTs. | Up to 28 days |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavourable and unintended sign (including physical examinations, vital signs, electrocardiogram (ECG), laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. TEAEs were defined as AEs that newly occurred or worsened on or after the start of study product administration. | From first dose of study drug administration up to 24 months |
| Percentage of Participants With Adverse Events of Clinical Interest (AECIs) | In this study, immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS), hemophagocytic lymphohistiocytosis (HLH), macrophage activation syndrome (MAS), and tumor lysis syndrome (TLS) were predefined as AECIs. CRS and ICANS were evaluated according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus. For management of HLH and MAS, CARTOX (CAR-T-cell-therapy-associated TOXicity) recommendations were used. | From first dose of study drug administration up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Assessed by Investigator According to RECIST 1.1 | ORR was defined as the percentage of participants whose best overall response was complete response (CR) or partial response (PR) as determined by the investigator per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Complete Response (CR): Disappearance of all target lesions (TL) and non-target lesions and normalization of tumor marker level. Partial response (PR): At least a 30 percent (%) decrease in the sum of the longest diameter (LD) of TL, taking as reference the baseline sum LD. |
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Inclusion Criteria
Histologically or cytologically confirmed advanced or metastatic solid tumors who have no option with or are intolerant of standard therapies with a proven clinical benefit.
Mesothelin-expression (>=50% positive on viable tumor cells) must be determined on the tumor by immunohistochemistry using a validated assay, scoring and staining confirmed by the sponsor prior to leukapheresis procedures.
Life expectancy >=12 weeks.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate organ function as confirmed by clinical laboratory values as specified below:
Total bilirubin =<1.5 × the upper limit of the normal range (ULN) except in Participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll with direct bilirubin =<3 × ULN of the direct bilirubin. Elevated indirect bilirubin due to posttransfusion hemolysis is allowed
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be <3 × ULN.
AST and ALT may be elevated up to 5 × ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in the liver.
Calculated creatinine clearance >50 mL/min (Cockcroft-Gault formula).
Hemoglobin must be >=9 g/dL.
Neutrophil count must be >1000/mm^3.
Absolute lymphocyte count must be >500/mm^3.
Platelet count must be >75,000/mm^3.
Participants must have radiographically measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital East | Kashiwa | Chiba | Japan | |||
| Hyogo College of Medicine Hospital |
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| Label | URL |
|---|---|
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants).
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A total of 20 participants were screened, of which 18 participants were screen failures and the remaining 2 were enrolled in the study. The study was terminated early by the sponsor due to a business decision unrelated to patient safety.
Participants took part in the study at 2 investigative sites in Japan from 05 January 2022 to 22 February 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-103, Cohort -2 | Participants with mesothelin expressing advanced or metastatic tumors received TAK-103 CAR (+) cells (1×10^6 CAR [+] cells/body) infusion, intravenously, once on Day 1. |
| FG001 | TAK-103, Cohort 1 | Participants with mesothelin expressing advanced or metastatic tumors received TAK-103 Chimeric antigen receptor (CAR) (+) cells (1×10^7 CAR [+] cells/body) infusion, intravenously, once on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Safety Analysis Set included participants who received any dose of TAK-103.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-103, Cohort -2 | Participants with mesothelin expressing advanced or metastatic tumors received TAK-103 CAR (+) cells (1×10^6 CAR [+] cells/body) infusion, intravenously, once on Day 1. |
| BG001 | TAK-103, Cohort 1 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Dose-Limiting Toxicities (DLTs) | DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Any Grade 3 or higher toxicities that were considered by the investigator to be at least possibly related to therapy with TAK-103 during the 28 days immediately after infusion of TAK-103 and, any adverse events (AEs) requiring endotracheal intubation or tracheostomy were considered as DLTs. | The DLT Analysis Set included participants who received any predetermined dose of TAK-103 and completed the assessment for DLT evaluation or experienced a DLT during the first 28 days following TAK-103 infusion. | Posted | Number | percentage of participants | Up to 28 days |
|
From first dose of study drug administration up to 24 months
Safety analysis set included participants who received any dose of TAK-103.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-103, Cohort -2 | Participants with mesothelin expressing advanced or metastatic tumors received TAK-103 CAR (+) cells (1×10^6 CAR [+] cells/body) infusion, intravenously, once on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytokine release syndrome | Immune system disorders | MedDRA Version 27.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
The study was terminated early by the sponsor due to a business decision unrelated to participant safety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2024 | Feb 19, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2024 | Feb 19, 2026 | SAP_001.pdf |
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| Up to 24 months |
| ORR Assessed by Investigator According to Immune RECIST (iRECIST) | ORR was defined as the percentage of participants whose best overall response was immune complete response (iCR) or immune partial response (iPR) as determined by the investigator per iRECIST. Immune Complete Response (iCR): Disappearance of all TL and Non-TL. All lymph nodes must be non-pathological in size (less than [<]10 millimeters [mm] in short axis diameter [SAD]). Immune Partial Response (iPR): Tumor load of the TL is reduced by less than or equal to (=<) 30% compared to the baseline, or in the case of complete remission of the TL, when one or more, non-TL can still be distinguished. Immune Stable Disease (iSD), which is to be determined if the criteria of iCR or iPR are not met and no tumor progression is present. | Up to 24 months |
| Disease Control Rate (DCR) Assessed by Investigator According to RECIST 1.1 | DCR was defined as the percentage of participants whose best overall response was CR, PR and stable disease (SD) or better as determined by the investigator per RECIST version 1.1. CR: Disappearance of all TL and Non-TL. All lymph nodes must be non-pathological in size (< 10 mm in SAD). PR: Tumor load of the TL is reduced by =<30% compared to the baseline, or in the case of complete remission of the TL, when one or more, Non-TL can still be distinguished.SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. SD have to be maintained for at least 24 days (around 4 weeks) after the TAK-103 infusion. | Up to 24 months |
| DCR Assessed by Investigator According to iRECIST | DCR was defined as the percentage of participants whose best overall response was iCR, iPR and iSD or better as determined by the investigator per iRECIST. iCR: Disappearance of all TL and Non-TL. All lymph nodes must be non-pathological in size (< 10 mm in SAD). iPR: Tumor load of the TL is reduced by =<30% compared to the baseline, or in the case of complete remission of the TL, when one or more, non-TL can still be distinguished. iSD: Determined if the criteria of iCR or iPR are not met and no tumor progression is present. | Up to 24 months |
| Duration of Response (DOR) Assessed by Investigator With RECIST 1.1 | DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of PD per RECIST version 1.1. PR: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | Up to 24 months |
| DOR Assessed by Investigator With iRECIST | DOR was defined as the time from the date of first documentation of an iPR or better to the date of first documentation of disease progression per iRECIST. iPR: Tumor load of the TL is reduced by =<30% compared to the baseline, or in the case of complete remission of the TL, when one or more, non-TL can still be distinguished. | Up to 24 months |
| Time to Progression (TTP) Assessed by Investigator With RECIST 1.1 | TTP was defined as the time from the TAK-103 infusion date to the date of first documented disease progression by the investigator per RECIST version 1.1. | Up to 24 months |
| TTP Assessed by Investigator With iRECIST | TTP was defined as the time from the TAK-103 infusion date to the date of first documented disease progression by the investigator per iRECIST. | Up to 24 months |
| Progression-Free Survival (PFS) Assessed by Investigator With RECIST 1.1 | PFS was defined as the time from the TAK-103 infusion date to the date of disease progression per RECIST version 1.1 or death from any cause, whichever occurred first. | Up to 24 months |
| PFS Assessed by Investigator With iRECIST | PFS was defined as the time from the TAK-103 infusion date to the date of disease progression per iRECIST or death from any cause, whichever occurred first. | Up to 24 months |
| Overall Survival (OS) | OS was defined as the time from the TAK-103 infusion date to the date of death from any cause. Participants who did not die were censored at the last known survival follow-up. | Up to 24 months |
| Cmax- Maximum Observed in Peripheral Blood Drug Concentration After Single Dose Administration by CAR Copy Number of TAK-103 | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18, 22, 29, Months 3, 4, 5, 7, 10, and 13) post-dose |
| Tmax- Time of First Occurrence of Maximum Observed Peripheral Blood Concentration by CAR Copy Number of TAK-103 | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18, 22, 29, Months 3, 4, 5, 7, 10, and 13) post-dose |
| Clast- Last Observed Quantifiable Concentration in Peripheral Blood by CAR Copy Number of TAK-103 | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18 and 22) post-dose |
| Tlast- Persistence: Time of Last Observed Quantifiable Concentration in Peripheral Blood (Days) by CAR Copy Number of TAK-103 | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18 and 22) post-dose |
| AUC- Area Under the Blood Concentration-Time Curve by CAR Copy Number of TAK-103 | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18, 22, and 29) post-dose |
| Number of Participants With Replication Competent Retrovirus (RCR)-Positive Test Results | Number of participants with RCR-Positive test results were reported. | Up to 24 months |
| Nishinomiya |
| Hyōgo |
| Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | Japan |
Participants with mesothelin expressing advanced or metastatic tumors received TAK-103 CAR (+) cells (1×10^7 CAR [+] cells/body) infusion, intravenously, once on Day 1.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | TAK-103, Cohort 1 | Participants with mesothelin expressing advanced or metastatic tumors received TAK-103 CAR (+) cells (1×10^7 CAR [+] cells/body) infusion, intravenously, once on Day 1. |
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| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavourable and unintended sign (including physical examinations, vital signs, electrocardiogram (ECG), laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. TEAEs were defined as AEs that newly occurred or worsened on or after the start of study product administration. | The Safety Analysis Set included participants who received any dose of TAK-103. | Posted | Number | percentage of participants | From first dose of study drug administration up to 24 months |
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| Primary | Percentage of Participants With Adverse Events of Clinical Interest (AECIs) | In this study, immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS), hemophagocytic lymphohistiocytosis (HLH), macrophage activation syndrome (MAS), and tumor lysis syndrome (TLS) were predefined as AECIs. CRS and ICANS were evaluated according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus. For management of HLH and MAS, CARTOX (CAR-T-cell-therapy-associated TOXicity) recommendations were used. | Safety analysis set included participants who received any dose of TAK-103. | Posted | Number | percentage of participants | From first dose of study drug administration up to 24 months |
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| Secondary | Overall Response Rate (ORR) Assessed by Investigator According to RECIST 1.1 | ORR was defined as the percentage of participants whose best overall response was complete response (CR) or partial response (PR) as determined by the investigator per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Complete Response (CR): Disappearance of all target lesions (TL) and non-target lesions and normalization of tumor marker level. Partial response (PR): At least a 30 percent (%) decrease in the sum of the longest diameter (LD) of TL, taking as reference the baseline sum LD. | The Response-Evaluable Analysis Set included participants who received any dose of TAK-103, had measurable disease at baseline and at least 1 post-treatment evaluation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to 24 months |
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| Secondary | ORR Assessed by Investigator According to Immune RECIST (iRECIST) | ORR was defined as the percentage of participants whose best overall response was immune complete response (iCR) or immune partial response (iPR) as determined by the investigator per iRECIST. Immune Complete Response (iCR): Disappearance of all TL and Non-TL. All lymph nodes must be non-pathological in size (less than [<]10 millimeters [mm] in short axis diameter [SAD]). Immune Partial Response (iPR): Tumor load of the TL is reduced by less than or equal to (=<) 30% compared to the baseline, or in the case of complete remission of the TL, when one or more, non-TL can still be distinguished. Immune Stable Disease (iSD), which is to be determined if the criteria of iCR or iPR are not met and no tumor progression is present. | The Response-Evaluable Analysis Set included participants who received any dose of TAK-103, had measurable disease at baseline and at least 1 post-treatment evaluation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to 24 months |
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| Secondary | Disease Control Rate (DCR) Assessed by Investigator According to RECIST 1.1 | DCR was defined as the percentage of participants whose best overall response was CR, PR and stable disease (SD) or better as determined by the investigator per RECIST version 1.1. CR: Disappearance of all TL and Non-TL. All lymph nodes must be non-pathological in size (< 10 mm in SAD). PR: Tumor load of the TL is reduced by =<30% compared to the baseline, or in the case of complete remission of the TL, when one or more, Non-TL can still be distinguished.SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. SD have to be maintained for at least 24 days (around 4 weeks) after the TAK-103 infusion. | The Response-Evaluable Analysis Set included participants who received any dose of TAK-103, had measurable disease at baseline and at least 1 post-treatment evaluation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to 24 months |
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| Secondary | DCR Assessed by Investigator According to iRECIST | DCR was defined as the percentage of participants whose best overall response was iCR, iPR and iSD or better as determined by the investigator per iRECIST. iCR: Disappearance of all TL and Non-TL. All lymph nodes must be non-pathological in size (< 10 mm in SAD). iPR: Tumor load of the TL is reduced by =<30% compared to the baseline, or in the case of complete remission of the TL, when one or more, non-TL can still be distinguished. iSD: Determined if the criteria of iCR or iPR are not met and no tumor progression is present. | The Response-Evaluable Analysis Set included participants who received any dose of TAK-103, had measurable disease at baseline and at least 1 post-treatment evaluation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to 24 months |
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| Secondary | Duration of Response (DOR) Assessed by Investigator With RECIST 1.1 | DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of PD per RECIST version 1.1. PR: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). | The study was terminated early by the sponsor due to a business decision unrelated to participant safety and the sponsor decided not to conduct the analysis for this outcome measure. Therefore, data for this outcome measure were not reported. | Posted | Up to 24 months |
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| Secondary | DOR Assessed by Investigator With iRECIST | DOR was defined as the time from the date of first documentation of an iPR or better to the date of first documentation of disease progression per iRECIST. iPR: Tumor load of the TL is reduced by =<30% compared to the baseline, or in the case of complete remission of the TL, when one or more, non-TL can still be distinguished. | The study was terminated early by the sponsor due to a business decision unrelated to participant safety and the sponsor decided not to conduct the analysis for this outcome measure. Therefore, data for this outcome measure were not reported. | Posted | Up to 24 months |
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| Secondary | Time to Progression (TTP) Assessed by Investigator With RECIST 1.1 | TTP was defined as the time from the TAK-103 infusion date to the date of first documented disease progression by the investigator per RECIST version 1.1. | The study was terminated early by the sponsor due to a business decision unrelated to participant safety and the sponsor decided not to conduct the analysis for this outcome measure. Therefore, data for this outcome measure were not reported. | Posted | Up to 24 months |
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| Secondary | TTP Assessed by Investigator With iRECIST | TTP was defined as the time from the TAK-103 infusion date to the date of first documented disease progression by the investigator per iRECIST. | The study was terminated early by the sponsor due to a business decision unrelated to participant safety and the sponsor decided not to conduct the analysis for this outcome measure. Therefore, data for this outcome measure were not reported. | Posted | Up to 24 months |
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| Secondary | Progression-Free Survival (PFS) Assessed by Investigator With RECIST 1.1 | PFS was defined as the time from the TAK-103 infusion date to the date of disease progression per RECIST version 1.1 or death from any cause, whichever occurred first. | The study was terminated early by the sponsor due to a business decision unrelated to participant safety and the sponsor decided not to conduct the analysis for this outcome measure. Therefore, data for this outcome measure were not reported. | Posted | Up to 24 months |
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| Secondary | PFS Assessed by Investigator With iRECIST | PFS was defined as the time from the TAK-103 infusion date to the date of disease progression per iRECIST or death from any cause, whichever occurred first. | The study was terminated early by the sponsor due to a business decision unrelated to participant safety and the sponsor decided not to conduct the analysis for this outcome measure. Therefore, data for this outcome measure were not reported. | Posted | Up to 24 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the TAK-103 infusion date to the date of death from any cause. Participants who did not die were censored at the last known survival follow-up. | Safety analysis set included participants who received any dose of TAK-103. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Median | Full Range | months | Up to 24 months |
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| Secondary | Cmax- Maximum Observed in Peripheral Blood Drug Concentration After Single Dose Administration by CAR Copy Number of TAK-103 | Cellular kinetics (CK) analysis set: Patients who received any dose of TAK-103 and had at least 1 CK parameter estimated were to be used for CK analysis. | Posted | Mean | Standard Deviation | copies/micro grams | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18, 22, 29, Months 3, 4, 5, 7, 10, and 13) post-dose |
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| Secondary | Tmax- Time of First Occurrence of Maximum Observed Peripheral Blood Concentration by CAR Copy Number of TAK-103 | Cellular kinetics (CK) analysis set: Patients who received any dose of TAK-103 and had at least 1 CK parameter estimated were to be used for CK analysis. | Posted | Mean | Standard Deviation | days | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18, 22, 29, Months 3, 4, 5, 7, 10, and 13) post-dose |
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| Secondary | Clast- Last Observed Quantifiable Concentration in Peripheral Blood by CAR Copy Number of TAK-103 | Cellular kinetics (CK) analysis set: Participants who received any dose of TAK-103 and had at least 1 CK parameter estimated were to be used for CK analysis. | Posted | Mean | Standard Deviation | copies/micro grams | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18 and 22) post-dose |
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| Secondary | Tlast- Persistence: Time of Last Observed Quantifiable Concentration in Peripheral Blood (Days) by CAR Copy Number of TAK-103 | Cellular kinetics (CK) analysis set: Participants who received any dose of TAK-103 and had at least 1 CK parameter estimated were to be used for CK analysis. | Posted | Mean | Standard Deviation | days | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18 and 22) post-dose |
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| Secondary | AUC- Area Under the Blood Concentration-Time Curve by CAR Copy Number of TAK-103 | Cellular kinetics (CK) analysis set: Patients who received any dose of TAK-103 and had at least 1 CK parameter estimated were to be used for CK analysis. | Posted | Mean | Standard Deviation | copies/micro grams*day | At Pre-dose and multiple time points (Day 1, 2, 4, 8, 11, 15, 18, 22, and 29) post-dose |
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| Secondary | Number of Participants With Replication Competent Retrovirus (RCR)-Positive Test Results | Number of participants with RCR-Positive test results were reported. | Safety analysis set included participants who received any dose of TAK-103. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to 24 months |
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| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| EG001 | TAK-103, Cohort 1 | Participants with mesothelin expressing advanced or metastatic tumors received TAK-103 CAR (+) cells (1×10^7 CAR [+] cells/body) infusion, intravenously, once on Day 1. | 1 | 1 | 1 | 1 | 1 | 1 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 27.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 27.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
|
| Blood fibrinogen decreased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 27.0 | Systematic Assessment |
|
Not provided
Not provided
| Participants with HLH (Percent) |
|
| Participants with MAS (Percent) |
|
| Participants with TLS (Percent) |
|