Trial Outcomes & Findings for Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors (NCT NCT05194735)

NCT ID: NCT05194735

Last Updated: 2025-11-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.

Results posted on

2025-11-10

Participant Flow

34 participants signed consent forms, 14 participants were apheresed, and 8 participants were lymphodepleted and per the protocol definition were considered enrolled. 8 were treated with TCR-T cells.

A total of 14 participants underwent apheresis. Per protocol, participants were considered enrolled upon meeting lymphodepletion criteria (n = 8). Six participants were not dosed due to manufacturing failure (n = 2), clinical deterioration (n = 1), or study closure prior to dosing (n = 3). BOIN accelerated dose escalation began with 1 subject at Dose Level 1; additional participants could be enrolled at safe dose levels based on manufactured cell count.

Participant milestones

Participant milestones
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) 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.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) 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.
Overall Study STARTED	1	13
Overall Study Apheresis 1	1	13
Overall Study Apheresis 2	0	2
Overall Study Manufacture 1	1	12
Overall Study Manufacture 2	0	2
Overall Study Lymphodepletion (Enrollment)	1	7
Overall Study TCR Infusion	1	7
Overall Study Assigned Dose Level 2 But Received Dose Level 1 Due to Manufacturing Process	0	2
Overall Study COMPLETED	1	7
Overall Study NOT COMPLETED	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) 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.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) 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.	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) 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.
Overall Study Apheresed but not administered TCR-T cells due to manufacturing failure	0	1	0
Overall Study Apheresed but not administered TCR-T cells due to participant developed brain metastases	0	1	0
Overall Study Apheresed but not administered TCR-T cells due to early termination of study	0	3	0
Overall Study Cells manufactured but not infused due to participant cerebrovascular accident	0	1	0

Baseline Characteristics

Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n=1 Participants Participants who received a single infusion of TCR-T cells manufactured at Dose Level 1.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) n=7 Participants Participants who received a single infusion of TCR-T cells manufactured at Dose Level 2.	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) Participants who received a single infusion of TCR-T cells manufactured at Dose Level 3.	Total n=8 Participants Total of all reporting groups
Age, Continuous	35 years n=5 Participants	54 years n=20 Participants	—	54 years n=28 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=20 Participants	0 Participants n=40 Participants	5 Participants n=28 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=20 Participants	0 Participants n=40 Participants	3 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=20 Participants	—	1 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	7 Participants n=20 Participants	—	7 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=20 Participants	—	0 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=20 Participants	—	0 Participants n=28 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=20 Participants	—	1 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	—	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=20 Participants	—	0 Participants n=28 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	4 Participants n=20 Participants	—	5 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	—	0 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=20 Participants	—	2 Participants n=28 Participants
Region of Enrollment United States	1 participants n=5 Participants	7 participants n=20 Participants	—	8 participants n=28 Participants
Tumor Type Colorectal	0 Participants n=5 Participants	4 Participants n=20 Participants	0 Participants n=40 Participants	4 Participants n=28 Participants
Tumor Type Pancreatic	0 Participants n=5 Participants	3 Participants n=20 Participants	0 Participants n=40 Participants	3 Participants n=28 Participants
Tumor Type Non-small cell lung cancer	1 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=28 Participants

PRIMARY outcome

Timeframe: From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.

Population: Participants who received a TCR-T cell infusion (Safety Analysis Set).

Outcome measures

Outcome measures
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n=1 Participants 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.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) n=7 Participants 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.	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) 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.
Number of Participants With Treatment-Emergent Adverse Events Any TEAE	1 participants	7 participants	—
Number of Participants With Treatment-Emergent Adverse Events Drug-related TEAE	1 participants	7 participants	—
Number of Participants With Treatment-Emergent Adverse Events Drug-related Grade 3 or higher TEAE	1 participants	6 participants	—
Number of Participants With Treatment-Emergent Adverse Events TEAE leading to death	0 participants	0 participants	—
Number of Participants With Treatment-Emergent Adverse Events Treatment-emergent SAE	1 participants	2 participants	—

PRIMARY outcome

Timeframe: From Day 0 to Day 28 post TCR-T cell drug product infusion.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n=1 Participants 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.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) n=7 Participants 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.	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) 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.
Frequency of Dose Limiting Toxicities	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: From Day 0 to Day 28 post TCR-T cell drug product infusion.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n=8 Participants 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.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) 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.	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) 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.
Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)	NA Dose level of TCR-T cells infused The MTD or RP2D could not be determined because the study closed early before sufficient participants were treated and evaluated for DLTs to allow formal determination.	—	—

SECONDARY outcome

Timeframe: From apheresis collection to the release of the final TCR-T cell drug product for infusion, estimated to be approximately 5 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n=14 Participants 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.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) 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.	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) 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.
Feasibility of TCR-T Cell Drug Product Manufacturing Unable to be apheresed for logistical or medical reasons	0 participants	—	—
Feasibility of TCR-T Cell Drug Product Manufacturing Apheresis performed but manufacturing not initiated due to study closure	2 participants	—	—
Feasibility of TCR-T Cell Drug Product Manufacturing Product was successfully manufactured but not administered due to progression or comorbidity.	2 participants	—	—
Feasibility of TCR-T Cell Drug Product Manufacturing Infused successfully at the planned dose after 1 manufacturing round.	6 participants	—	—
Feasibility of TCR-T Cell Drug Product Manufacturing Infused at a lower dose than planned after 1 manufacturing round.	1 participants	—	—
Feasibility of TCR-T Cell Drug Product Manufacturing Infused at a lower dose than planned after 2 manufacturing rounds.	1 participants	—	—
Feasibility of TCR-T Cell Drug Product Manufacturing Patients who were manufacturing failures after 2 manufacturing rounds.	1 participants	—	—
Feasibility of TCR-T Cell Drug Product Manufacturing Product was successfully manufactured but not administered due to study closure.	1 participants	—	—

SECONDARY outcome

Timeframe: Baseline through Month 18 post-infusion.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n=1 Participants 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.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) n=7 Participants 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.	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) 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.
TCR-T Cell Persistence Day 10	674,000 copies/1x10^6 cells	112,000 copies/1x10^6 cells	—
TCR-T Cell Persistence Day 14	984,000 copies/1x10^6 cells	112,000 copies/1x10^6 cells	—
TCR-T Cell Persistence Day 21	504,000 copies/1x10^6 cells	41,300 copies/1x10^6 cells	—
TCR-T Cell Persistence Day 28	404,000 copies/1x10^6 cells	32,100 copies/1x10^6 cells Interval 0.0 to	—
TCR-T Cell Persistence Week 6	197,000 copies/1x10^6 cells	27,800 copies/1x10^6 cells Interval 0.0 to	—
TCR-T Cell Persistence Week 12	163,000 copies/1x10^6 cells	27,200 copies/1x10^6 cells	—
TCR-T Cell Persistence Month 3	—	42,400 copies/1x10^6 cells	—
TCR-T Cell Persistence Month 6	88,100 copies/1x10^6 cells	8,120 copies/1x10^6 cells	—
TCR-T Cell Persistence Baseline (1 week prior to infusion)	NA copies/1x10^6 cells Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.	NA copies/1x10^6 cells Interval 0.0 to 0.0 Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.	—
TCR-T Cell Persistence Predose Day 0	NA copies/1x10^6 cells Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.	NA copies/1x10^6 cells Interval 0.0 to 0.0 Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.	—
TCR-T Cell Persistence Post Dose Day 0	4,240,000 copies/1x10^6 cells	2,570,000 copies/1x10^6 cells	—
TCR-T Cell Persistence Day 1	3,190,000 copies/1x10^6 cells	59,200 copies/1x10^6 cells	—
TCR-T Cell Persistence Day 2	2,640,000 copies/1x10^6 cells	408,000 copies/1x10^6 cells Interval 0.0 to	—
TCR-T Cell Persistence Day 4	3,500,000 copies/1x10^6 cells	570,000 copies/1x10^6 cells	—
TCR-T Cell Persistence Day 7	743,000 copies/1x10^6 cells	101,000 copies/1x10^6 cells	—
TCR-T Cell Persistence Month 15	—	NA copies/1x10^6 cells Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.	—
TCR-T Cell Persistence Month 18	—	NA copies/1x10^6 cells Values listed as "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" could not be quantified by the qPCR assay and are therefore reported as NA.	—

SECONDARY outcome

Timeframe: Post-dose through Day 28

Population: 8 participants received TCR-T infusion and were included in the analysis (1 assigned at Dose Level 1, 7 assigned at Dose Level 2).

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.

Outcome measures

Outcome measures
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n=1 Participants 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.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) n=7 Participants 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.	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) 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.
Percent Change in TCR-T Cell Count From Post Dose to Day 28	-90.5 percent change from peak post dose	-96.7 percent change from peak post dose Interval -100.0 to -91.1	—

Adverse Events

Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 6 deaths

Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n=1 participants at risk 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.	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) n=7 participants at risk 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.	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) 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.
Immune system disorders Cytokine release syndrome	100.0% 1/1 • Number of events 1 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	28.6% 2/7 • Number of events 2 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	— 0/0 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.
Vascular disorders Hypotension	100.0% 1/1 • Number of events 1 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	0.00% 0/7 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	— 0/0 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	100.0% 1/1 • Number of events 2 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	0.00% 0/7 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	— 0/0 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.
Cardiac disorders Sinus tachycardia	100.0% 1/1 • Number of events 2 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	0.00% 0/7 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	— 0/0 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 1/1 • Number of events 1 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	0.00% 0/7 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	— 0/0 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.
Blood and lymphatic system disorders Anaemia	100.0% 1/1 • Number of events 1 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	0.00% 0/7 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	— 0/0 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.
Blood and lymphatic system disorders Febrile neutropenia	100.0% 1/1 • Number of events 1 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	0.00% 0/7 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.	— 0/0 • From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion. 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.

Other adverse events

Additional Information

Jaymes Holland

Alaunos Therapeutics, Inc.

Phone: 6502732627

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Per the clinical trial agreement, the PI may not publish results until after a multi-center publication or a defined period post-study. The sponsor reviews any proposed publication and may delay it to protect proprietary information or file IP. Sponsor controls timing and content of multi-center publications.
Publication restrictions are in place

Restriction type: OTHER