Solid TumorsPhase 1NCT05164666
A Study of TAK-103 in Adult With Solid Tumors
A Phase 1 study testing TAK-103 in people with Solid Tumors, run by Takeda at 3 sites in Japan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- TAK-103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesJapan
- Study dates
- 5 Jan 2022to 22 Feb 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- Active systemic infections.
- Known hepatitis B surface antigen (HBsAg) positive, or known or suspected active hepatitis C virus (HCV) infection. Participants who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B virus (HBV) viral load. Participants who have positive hepatitis C virus antibody (HCVAb) must have an undetectable HCV viral load.
- Coagulation disorders, or other major medical illnesses including respiratory or immune system disease.
- Participants with high tumor burden at the disease assessment at screening. The tumor burden is determined by the threshold set for each type of cancer.
- Participants with current or history of interstitial lung disease.
- Participants with current or history of significant immune-related adverse events (irAEs) related to treatment with immune checkpoint inhibitors. Patients with current or history of the following adverse events (AEs) can be enrolled after careful discussion between the investigator and sponsor: hyperglycemia/diabetes mellitus, thyroid disorder, hypopituitarism, hypoadrenocorticism, asymptomatic elevation in amylase/lipase, and Grade1 or 2 skin toxicity.
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- Participants with known cardiovascular and cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, myocardial infarction, congestive heart failure, left ventricular ejection fraction (LVEF) <45 %, impaired respiratory function, baseline oxygen saturation <93% on room air. A well-controlled atrial fibrillation would not be an exclusion whereas uncontrolled atrial fibrillation would be an exclusion.
- Participants with any signs of lymphoma and/or leukemia.
- Participants who are diagnosed with or treated for another malignancy within 3 years before leukapheresis procedures. Participants with non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) would be included if they were adequately treated.
- Any disease requiring systemic steroid treatment.
- Any prior use of cell and gene therapy(ies).
- Treatment with any investigational products (except for cell or gene therapy) within 14 days before leukapheresis procedures or 28 days before treatment with conditioning chemotherapy/TAK-103.
- Systemic anticancer therapy (including immuno-oncology therapies) and treatment with radiotherapy within 14 days before leukapheresis procedures or treatment with conditioning chemotherapy/TAK-103.
- Treatment with major surgery within 28 days before leukapheresis procedures or treatment with conditioning chemotherapy/TAK-103 (minor surgical procedures such as catheter placement are not exclusionary criteria).
- Previous treatment with any mesothelin-targeted therapy.
- Any unresolved toxicity of Grade 3 or higher from previous anticancer therapy.
- Participants with risk of bleeding as judged by the investigator.
- Presence of central nervous system metastasis or other significant neurological conditions (Participant with central nervous system metastases that have been effectively treated where necessary and stable can be enrolled).
- Participants with human immunodeficiency virus (HIV) seropositive and/or human T-cell lymphotropic virus (HTLV) seropositive.
- Participants with a history of organ transplantation or awaiting organ transplantation.
- Participants with severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or streptomycin.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
National Cancer Center Hospital
Chuo-ku, Tokyo
National Cancer Center Hospital East
Kashiwa, Chiba
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo
About this study
Official title: An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-103 in Adult Patients With Mesothelin-Expressing Advanced or Metastatic Solid Tumors
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.
- Conditions
- Solid Tumors
- Being tested
- TAK-103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-103Biological
TAK-103 intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: TAK-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From first dose of study drug administration up to 24 months
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Cmax- Maximum Observed in Peripheral Blood Drug Concentration After Single Dose Administration by CAR Copy Number of TAK-103
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start5 Jan 2022
- Primary completion22 Feb 2025
- Study completion22 Feb 2025
Why it stopped: Business decision unrelated to patient safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164666
- Sponsor's protocol ID
- TAK-103-1001
- Other IDs
- jRCT2033210463
- Status last verified
- Jul 2026
- First submitted
- 23 Nov 2021
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-103 in Adult Patients With Mesothelin-Expressing Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05164666
- Acronym / sponsor ID
- TAK-103-1001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision unrelated to patient safety
- Enrolment
- 2 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Posted 7 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-103, Dose Escalation | Experimental | Biological: TAK-103TAK-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (21 listed)
- Active systemic infections.
- Known hepatitis B surface antigen (HBsAg) positive, or known or suspected active hepatitis C virus (HCV) infection. Participants who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B virus (HBV) viral load. Participants who have positive hepatitis C virus antibody (HCVAb) must have an undetectable HCV viral load.
- Coagulation disorders, or other major medical illnesses including respiratory or immune system disease.
- Participants with high tumor burden at the disease assessment at screening. The tumor burden is determined by the threshold set for each type of cancer.
- Participants with current or history of interstitial lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-103TAK-103 intravenous infusion | Biological | TAK-103, Dose Escalation |
Primary outcome
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Up to 28 days
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.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug administration up to 24 months
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.
Percentage of Participants With Adverse Events of Clinical Interest (AECIs)
Time frame: From first dose of study drug administration up to 24 months
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.
17 secondary outcomes
Overall Response Rate (ORR) Assessed by Investigator According to RECIST 1.1
Time frame: Up to 24 months
ORR Assessed by Investigator According to Immune RECIST (iRECIST)
Time frame: Up to 24 months
Disease Control Rate (DCR) Assessed by Investigator According to RECIST 1.1
Time frame: Up to 24 months
DCR Assessed by Investigator According to iRECIST
Time frame: Up to 24 months
Duration of Response (DOR) Assessed by Investigator With RECIST 1.1
Time frame: Up to 24 months
DOR Assessed by Investigator With iRECIST
Time frame: Up to 24 months
Time to Progression (TTP) Assessed by Investigator With RECIST 1.1
Time frame: Up to 24 months
TTP Assessed by Investigator With iRECIST
Time frame: Up to 24 months
Progression-Free Survival (PFS) Assessed by Investigator With RECIST 1.1
Time frame: Up to 24 months
PFS Assessed by Investigator With iRECIST
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Cmax- Maximum Observed in Peripheral Blood Drug Concentration After Single Dose Administration by CAR Copy Number of TAK-103
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-103 in people with Solid Tumors, run by Takeda at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Dose-Limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.