TriangleNCT05194735 · STUDY IN CONTEXT
Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Treatment-emergent adverse events (TEAEs) were defined as any adverse event that began or worsened after initiation of lymphodepletion and up to 28 days following TCR-T cell infusion. TEAEs were coded using MedDRA and summarized by system organ class and preferred term, severity, and relationship to study treatment. Participants were followed for delayed or ongoing toxicities for up to 1 year.
Number of participants experiencing DLTs, defined as specific adverse events attributable to the TCR-T cell drug product occurring within the first 28 days of infusion. DLTs include, but are not limited to, Grade 4 neutropenia lasting ≥ 14 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding, and ≥ Grade 3 febrile neutropenia with hemodynamic compromise. Non-hematologic DLTs include Grade 3 or 4 Cytokine Release Syndrome (CRS) that does not improve to Grade ≤ 2 within 72 hours, and Grade 3 Immune-effector cell-associated neurotoxicity syndrome (ICANS) that does not resolve to Grade ≤ 2 within 7 days, among others. The severity of adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
The MTD and/or RP2D was to be determined based on dose-limiting toxicities observed during the dose-escalation phase. The planned definition required ≥2 patients at a given dose level to experience a DLT to declare that dose not tolerated.
Feasibility will be assessed by the number of participants who met eligibility criteria at each step of the manufacturing process, including inability to undergo apheresis, failure of product manufacture, manufactured product not infused, and successful manufacture and infusion of TCR-T cell drug product.
Persistence of TCR-T cells in peripheral blood was assessed by quantitative PCR for vector copy number per 1 × 10⁶ cells at baseline (1 week prior to infusion), predose (Day 0), and multiple post-infusion time points through Month 18. Only quantifiable values are summarized. Samples with "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" are reported as NA and excluded from summary statistics.
Assessed by comparing each participant's highest post-dose TCR-T cell count (copies per 1×10⁶ cells by qPCR) to the TCR-T cell count at Day 28. Percent change was calculated as: ((Day 28 - peak post-dose) / peak post-dose) × 100.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- trial label
- Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0000
- source section id
- NCT05194735-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Treatment-Emergent Adverse Events
- endpoint definition
- Treatment-emergent adverse events (TEAEs) were defined as any adverse event that began or worsened after initiation of lymphodepletion and up to 28 days following TCR-T cell infusion. TEAEs were coded using MedDRA and summarized by system organ class and preferred term, severity, and relationship to study treatment. Participants were followed for delayed or ongoing toxicities for up to 1 year.
- time origin
- From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received a TCR-T cell infusion (Safety Analysis Set).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0001
- source section id
- NCT05194735-om-0001
- source outcome index
- 1
- endpoint
- Frequency of Dose Limiting Toxicities
- endpoint definition
- Number of participants experiencing DLTs, defined as specific adverse events attributable to the TCR-T cell drug product occurring within the first 28 days of infusion. DLTs include, but are not limited to, Grade 4 neutropenia lasting ≥ 14 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding, and ≥ Grade 3 febrile neutropenia with hemodynamic compromise. Non-hematologic DLTs include Grade 3 or 4 Cytokine Release Syndrome (CRS) that does not improve to Grade ≤ 2 within 72 hours, and Grade 3 Immune-effector cell-associated neurotoxicity syndrome (ICANS) that does not resolve to Grade ≤ 2 within 7 days, among others. The severity of adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
- time origin
- From Day 0 to Day 28 post TCR-T cell drug product infusion.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received the planned TCR-T cell infusion and either experienced a DLT or completed the 28-day DLT observation period; those with major protocol deviations unrelated to safety during this period were considered non-evaluable.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0002
- source section id
- NCT05194735-om-0002
- source outcome index
- 2
- endpoint
- Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)
- endpoint definition
- The MTD and/or RP2D was to be determined based on dose-limiting toxicities observed during the dose-escalation phase. The planned definition required ≥2 patients at a given dose level to experience a DLT to declare that dose not tolerated.
- time origin
- From Day 0 to Day 28 post TCR-T cell drug product infusion.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received a TCR-T infusion and were monitored for DLTs were included in a single analysis population. Eight participants were infused (6 at Dose Level 1, 2 at Dose Level 2). The MTD/RP2D could not be determined because the study closed early before enough evaluable participants were treated to allow formal determination.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0003
- source section id
- NCT05194735-om-0003
- source outcome index
- 3
- endpoint
- Feasibility of TCR-T Cell Drug Product Manufacturing
- endpoint definition
- Feasibility will be assessed by the number of participants who met eligibility criteria at each step of the manufacturing process, including inability to undergo apheresis, failure of product manufacture, manufactured product not infused, and successful manufacture and infusion of TCR-T cell drug product.
- time origin
- From apheresis collection to the release of the final TCR-T cell drug product for infusion, estimated to be approximately 5 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The feasibility analysis included 14 participants who underwent apheresis with intent to manufacture TCR-T cell product. Although only 8 met criteria for lymphodepletion and were considered formally enrolled per protocol, all 14 apheresed participants were included for feasibility assessment because manufacturing could be attempted for each.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0004
- source section id
- NCT05194735-om-0004
- source outcome index
- 4
- endpoint
- TCR-T Cell Persistence
- endpoint definition
- Persistence of TCR-T cells in peripheral blood was assessed by quantitative PCR for vector copy number per 1 × 10⁶ cells at baseline (1 week prior to infusion), predose (Day 0), and multiple post-infusion time points through Month 18. Only quantifiable values are summarized. Samples with "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" are reported as NA and excluded from summary statistics.
- time origin
- Baseline through Month 18 post-infusion.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Persistence analyses included the 8 participants who received TCR-T infusion (1 at Dose Level 1 and 7 at Dose Level 2). A total of 14 participants underwent apheresis, but only infused participants were evaluable for persistence. Samples with "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" were not quantifiable and are reported as NA. Participants without samples at a given time point were excluded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0005
- source section id
- NCT05194735-om-0005
- source outcome index
- 5
- endpoint
- Percent Change in TCR-T Cell Count From Post Dose to Day 28
- endpoint definition
- Assessed by comparing each participant's highest post-dose TCR-T cell count (copies per 1×10⁶ cells by qPCR) to the TCR-T cell count at Day 28. Percent change was calculated as: ((Day 28 - peak post-dose) / peak post-dose) × 100.
- time origin
- Post-dose through Day 28
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 8 participants received TCR-T infusion and were included in the analysis (1 assigned at Dose Level 1, 7 assigned at Dose Level 2).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0002
- arm key
- OG000
- arm label
- All Dose Levels (DLT-Evaluable Population)
- regimen
- Includes all participants who received a TCR-T cell infusion and were monitored for DLTs across all dose levels (6 participants at Dose Level 1 and 2 participants at Dose Level 2; total = 8).
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Apheresed Participants (Feasibility Population)
- regimen
- Includes all 14 participants who underwent apheresis with intent to manufacture TCR-T cell drug product. Although only 8 met criteria for lymphodepletion and were considered enrolled per protocol, all 14 were included for assessment of manufacturing feasibility.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0004
- arm key
- OG002
- arm label
- Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0004#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
- regimen
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05194735-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- harm key
- EG000
- source section id
- NCT05194735-ae
- event group key
- EG000
- event group label
- Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
- serious affected
- 1
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 0
- collection period
- From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion.
- event definition
- Adverse events (AEs) were collected from initiation of lymphodepletion through 28 days after TCR-T cell infusion and during long-term follow-up for up to 1 year. AEs were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-emergent adverse events (TEAEs) were defined as those that began or worsened after initiation of lymphodepletion.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- harm key
- EG001
- source section id
- NCT05194735-ae
- event group key
- EG001
- event group label
- Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
- serious affected
- 2
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 0
- collection period
- From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion.
- event definition
- Adverse events (AEs) were collected from initiation of lymphodepletion through 28 days after TCR-T cell infusion and during long-term follow-up for up to 1 year. AEs were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-emergent adverse events (TEAEs) were defined as those that began or worsened after initiation of lymphodepletion.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-adenocarcinoma
- nct id
- NCT05194735
- harm key
- EG002
- source section id
- NCT05194735-ae
- event group key
- EG002
- event group label
- Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion.
- event definition
- Adverse events (AEs) were collected from initiation of lymphodepletion through 28 days after TCR-T cell infusion and during long-term follow-up for up to 1 year. AEs were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-emergent adverse events (TEAEs) were defined as those that began or worsened after initiation of lymphodepletion.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice