Trial Outcomes & Findings for Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer (NCT NCT03747484)

Last Updated: 2025-03-06

Results Overview

Assessed per Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Evidence of excessive toxicity will be an observed proportion of toxicities for which the associated lower 80% confidence limit exceeds 40%.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to 1 year post infusion

Results posted on

2025-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 - Radiation + One Infusion at DL1 Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 2 - Radiation + One Infusion at DL2 Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 2 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 Following treatment with single fraction radiation to a single lesion, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 Following lymphodepleting chemotherapy with fludarabine and cyclophosphamide, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 5 - Interferon Gamma + One Infusion at DL1 Following treatment with interferon gamma given subcutaneously three times per week for 4 weeks starting 5-7 days before T cell infusion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV Interferon Gamma-1b: Given SC
Overall Study STARTED	1	1	1	2	2
Overall Study COMPLETED	1	0	0	0	0
Overall Study NOT COMPLETED	0	1	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 - Radiation + One Infusion at DL1 Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 2 - Radiation + One Infusion at DL2 Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 2 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 Following treatment with single fraction radiation to a single lesion, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 Following lymphodepleting chemotherapy with fludarabine and cyclophosphamide, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 5 - Interferon Gamma + One Infusion at DL1 Following treatment with interferon gamma given subcutaneously three times per week for 4 weeks starting 5-7 days before T cell infusion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV Interferon Gamma-1b: Given SC
Overall Study Lack of Efficacy	0	1	1	2	2

Baseline Characteristics

Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 - Radiation + One Infusion at DL1 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 2 - Radiation + One Infusion at DL2 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 2 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 4 - Cy/Flu + 1 Infusion at DL1 + 1 Infusion at DL2 n=2 Participants Following lymphodepleting chemotherapy with fludarabine and cyclophosphamide, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 5 - Interferon Gamma + One Infusion at DL1 n=2 Participants Following treatment with interferon gamma given subcutaneously three times per week for 4 weeks starting 5-7 days before T cell infusion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV Interferon Gamma-1b: Given SC	Total n=7 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 0 • n=5 Participants	63 years STANDARD_DEVIATION 0 • n=7 Participants	62 years STANDARD_DEVIATION 0 • n=5 Participants	53 years STANDARD_DEVIATION 20 • n=4 Participants	70 years STANDARD_DEVIATION 4 • n=21 Participants	63 years STANDARD_DEVIATION 11 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	7 participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 1 year post infusion

Population: Population included all enrolled and treated participants.

Outcome measures

Outcome measures
Measure	Cohort 1 - Radiation + One Infusion at DL1 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 2 - Radiation + One Infusion at DL2 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 2 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 3 - Radiation + One Infusion at DL1 + One Infusion at DL2 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV	Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 n=2 Participants Following lymphodepleting chemotherapy with fludarabine and cyclophosphamide, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 5 - Interferon Gamma + One Infusion at DL1 n=2 Participants Following treatment with interferon gamma given subcutaneously three times per week for 4 weeks starting 5-7 days before T cell infusion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV Interferon Gamma-1b: Given SC
Incidence of Adverse Events Grade 3 or Higher Determined to be Possibly, Probably or Definitely Secondary to Study Treatments.	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 1 year post infusion

Population: Population included all enrolled and treated participants.

Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of complete or partial response. Irradiated and non-irradiated lesions will be separately tracked but response determined in totality.

Outcome measures

Outcome measures
Measure	Cohort 1 - Radiation + One Infusion at DL1 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 2 - Radiation + One Infusion at DL2 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 2 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 3 - Radiation + One Infusion at DL1 + One Infusion at DL2 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV	Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 n=2 Participants Following lymphodepleting chemotherapy with fludarabine and cyclophosphamide, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 5 - Interferon Gamma + One Infusion at DL1 n=2 Participants Following treatment with interferon gamma given subcutaneously three times per week for 4 weeks starting 5-7 days before T cell infusion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV Interferon Gamma-1b: Given SC
Best Overall Response Complete Response (CR)	0 participants	0 participants	0 participants	0 participants	0 participants
Best Overall Response Partial Response (PR)	0 participants	0 participants	0 participants	0 participants	0 participants
Best Overall Response Observed Response Rate (CR+PR)	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 1 year post infusion

Population: All enrolled and treated participants.

Will be estimated using the method of Kaplan and Meier, with time zero the time of first T cell infusion.

Outcome measures

Outcome measures
Measure	Cohort 1 - Radiation + One Infusion at DL1 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 2 - Radiation + One Infusion at DL2 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 2 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 3 - Radiation + One Infusion at DL1 + One Infusion at DL2 n=2 Participants Following treatment with single fraction radiation to a single lesion, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV	Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 n=2 Participants Following lymphodepleting chemotherapy with fludarabine and cyclophosphamide, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 5 - Interferon Gamma + One Infusion at DL1 n=2 Participants Following treatment with interferon gamma given subcutaneously three times per week for 4 weeks starting 5-7 days before T cell infusion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV Interferon Gamma-1b: Given SC
Progression-free Survival	2.8 months Upper and lower confidence interval for PFS could not be estimated due to insufficient number of events (e.g., participants with disease progression within the time frame for observation).	0.72 months Upper and lower confidence interval for PFS could not be estimated due to insufficient number of events (e.g., participants with disease progression within the time frame for observation).	2.0 months Upper and lower confidence interval for PFS could not be estimated due to insufficient number of events (e.g., participants with disease progression within the time frame for observation).	0.92 months Interval 0.89 to Upper confidence interval for PFS could not be estimated due to insufficient number of events (e.g., participants with disease progression within the time frame for observation).	0.90 months Interval 0.82 to Upper confidence interval for PFS could not be estimated due to insufficient number of events (e.g., participants with disease progression within the time frame for observation).

SECONDARY outcome

Timeframe: Up to 1 year post infusion

Population: Population included all enrolled and treated participants.

Will be estimated using the method of Kaplan and Meier, with time zero the time of first T cell infusion.

Outcome measures

Outcome measures
Measure	Cohort 1 - Radiation + One Infusion at DL1 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 2 - Radiation + One Infusion at DL2 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 2 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 3 - Radiation + One Infusion at DL1 + One Infusion at DL2 n=1 Participants Following treatment with single fraction radiation to a single lesion, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV	Cohort 4 - Cy/Flu + One Infusion at DL1 + One Infusion at DL2 n=2 Participants Following lymphodepleting chemotherapy with fludarabine and cyclophosphamide, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 5 - Interferon Gamma + One Infusion at DL1 n=2 Participants Following treatment with interferon gamma given subcutaneously three times per week for 4 weeks starting 5-7 days before T cell infusion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV Interferon Gamma-1b: Given SC
Overall Survival	NA months Due to insufficient number of participants and events (e.g., death), median OS could not be calculated, and upper and lower confidence interval for OS could not be obtained using Kaplan-Meier estimates.	NA months Due to insufficient number of participants and events (e.g., death), median OS could not be calculated, and upper and lower confidence interval for OS could not be obtained using Kaplan-Meier estimates.	11 months Due to insufficient number of participants and events (e.g., death), upper and lower confidence interval for OS could not be obtained using Kaplan-Meier estimates.	7.6 months Interval 6.1 to Due to insufficient number of participants and events (e.g., death), upper confidence interval for OS could not be obtained using Kaplan-Meier estimates.	NA months Due to insufficient number of participants and events (e.g., death), median OS could not be calculated, and upper and lower confidence interval for OS could not be obtained using Kaplan-Meier estimates.

Adverse Events

Cohort 1 - Radiation + One Infusion at DL1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2 - Radiation + One Infusion at DL2

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Cohort 4 - Cy/Flu + 1 Infusion at DL1 + 1 Infusion at DL2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Cohort 5 - Interferon Gamma + One Infusion at DL1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 - Radiation + One Infusion at DL1 n=1 participants at risk Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 2 - Radiation + One Infusion at DL2 n=1 participants at risk Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 2 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 n=1 participants at risk Following treatment with single fraction radiation to a single lesion, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 4 - Cy/Flu + 1 Infusion at DL1 + 1 Infusion at DL2 n=2 participants at risk Following lymphodepleting chemotherapy with fludarabine and cyclophosphamide, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 5 - Interferon Gamma + One Infusion at DL1 n=2 participants at risk Following treatment with interferon gamma given subcutaneously three times per week for 4 weeks starting 5-7 days before T cell infusion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV Interferon Gamma-1b: Given SC
General disorders Fever	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	100.0% 1/1 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Vascular disorders Hypotension	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	100.0% 1/1 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	100.0% 1/1 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	100.0% 1/1 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.

Other adverse events

Other adverse events
Measure	Cohort 1 - Radiation + One Infusion at DL1 n=1 participants at risk Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 2 - Radiation + One Infusion at DL2 n=1 participants at risk Following treatment with single fraction radiation to a single lesion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 2 over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 3 - Radiation + One Infusion DL1 and One Infusion at DL2 n=1 participants at risk Following treatment with single fraction radiation to a single lesion, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 4 - Cy/Flu + 1 Infusion at DL1 + 1 Infusion at DL2 n=2 participants at risk Following lymphodepleting chemotherapy with fludarabine and cyclophosphamide, patients received FH-MCVA2TCR T-cells at Dose Level 1 IV over 60-120 minutes. Beginning 14 days after receiving FH-MCVA2TCR T-cells, patients also received standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with partial response or stable disease may then receive an additional cycle of FH-MCVA2TCR T-cells at Dose Level 2. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Dose Level 2: Inclusion Range 3.01 x 10\^8 - 9.35 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV	Cohort 5 - Interferon Gamma + One Infusion at DL1 n=2 participants at risk Following treatment with interferon gamma given subcutaneously three times per week for 4 weeks starting 5-7 days before T cell infusion, patients receive FH-MCVA2TCR T-cells IV at Dose Level 1 over 60-120 minutes. Beginning14 days after receiving FH-MCVA2TCR T-cells, patients also receive standard of care avelumab IV over 1 hour every 2 weeks for 1 year or pembrolizumab IV over 30 minutes every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Dose Level 1: 1 x 10\^8 FH-MCVATCR T-cells/kg Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR: Given IV Avelumab: Given IV Pembrolizumab: Given IV Interferon Gamma-1b: Given SC
Injury, poisoning and procedural complications Altered Mental Status	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	100.0% 1/1 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Blood and lymphatic system disorders Anemia	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Metabolism and nutrition disorders Anorexia	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Cardiac disorders Bradycardia	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
General disorders Chills	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
General disorders Edema limbs	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
General disorders Fatigue	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Investigations Lymphocyte Count Decreased	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Gastrointestinal disorders Nausea	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	100.0% 2/2 • Number of events 2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Investigations Neutrophil Count Decreased	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	100.0% 2/2 • Number of events 2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/2 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.
Investigations White Blood Cell Decreased	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	0.00% 0/1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.	50.0% 1/2 • Number of events 1 • All-Cause Mortality, serious adverse events, and other (not including serious) adverse events considered related to T Cell infusion were assessed from the time of the first T Cell infusion until the end of study, 12 months total.

Additional Information

Joshua Veatch

Fred Hutchinson Cancer Center

Phone: 206.667.5108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place