Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations
NCT ID: NCT06043713
Last Updated: 2025-12-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-12-15
Study Completion Date
2028-01-01
Brief Summary
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This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ transgenic T cells expressing high affinity KRASG12V mutation-specific T cell receptors (FH-A11KRASG12V-TCR) and to see how well they work in treating patients with solid tumor cancers that has spread from where it first started (primary site) to other places in the body (metastatic). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize KRAS G12V, a protein on the surface of tumor cells. These KRAS G12V-specific T cells may help the body's immune system identify and kill KRAS G12V solid cancer tumor cells.
Detailed Description
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OUTLINE: This is a dose-escalation study of FHA11KRASG12V-TCR.
Patients undergo leukapheresis prior to treatment and receive lymphodepletion chemotherapy with either cyclophosphamide intravenously (IV) and fludarabine IV on days -6, -5, and -4, or bendamustine IV on days -4 and -3 at the discretion of the treating clinician and/or principal investigator (PI). Patients then receive FHA11KRASG12V-TCR IV on day 0. Patients may receive an additional FHA11KRASG12V-TCR IV infusion as soon as 28 days or up to 1 year after the first infusion. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) as well as blood sample collection and a tissue biopsy at baseline and throughout the trial.
After completion of study treatment, patients are followed up on day 56, 112, 168, 224, 280 and day 365, then long-term for up to 15 years.
Patients undergo leukapheresis prior to treatment and receive lymphodepletion chemotherapy with either cyclophosphamide intravenously (IV) and fludarabine IV on days -6, -5, and -4, or bendamustine IV on days -4 and -3 at the discretion of the treating clinician and/or principal investigator (PI). Patients then receive FHA11KRASG12V-TCR IV on day 0. Patients may receive an additional FHA11KRASG12V-TCR IV infusion as soon as 28 days or up to 1 year after the first infusion. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) as well as blood sample collection and a tissue biopsy at baseline and throughout the trial.
After completion of study treatment, patients are followed up on day 56, 112, 168, 224, 280 and day 365, then long-term for up to 15 years.
Conditions
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Metastatic Malignant Solid Neoplasm
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment (FHA11KRASG12V-TCR)
Patients undergo leukapheresis prior to treatment and receive lymphodepletion chemotherapy with either cyclophosphamide IV and fludarabine IV on days -6, -5, and -4, or bendamustine IV on days -4 and -3 at the discretion of the treating clinician and/or PI. Patients then receive FHA11KRASG12V-TCR IV on day 0. Patients may receive an additional FHA11KRASG12V-TCR IV infusion as soon as 28 days or up to 1 year after the first infusion. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, PET or MRI as well as blood sample collection and a tissue biopsy at baseline and throughout the trial.
Group Type
EXPERIMENTAL
Bendamustine
Intervention Type
DRUG
Receive IV
Biopsy
Intervention Type
PROCEDURE
Undergo tissue biopsy
Biospecimen Collection
Intervention Type
PROCEDURE
Undergo blood sample collection
Computed Tomography
Intervention Type
PROCEDURE
Undergo CT
Cyclophosphamide
Intervention Type
DRUG
Receive IV
Echocardiography
Intervention Type
PROCEDURE
Undergo ECHO
Fludarabine
Intervention Type
DRUG
Receive IV
Leukapheresis
Intervention Type
PROCEDURE
Undergo leukapheresis
Magnetic Resonance Imaging
Intervention Type
PROCEDURE
Undergo MRI
Multigated Acquisition Scan
Intervention Type
PROCEDURE
Undergo MUGA
Positron Emission Tomography
Intervention Type
PROCEDURE
Undergo PET
T-cell Receptor-engineered T-cells
Intervention Type
BIOLOGICAL
Receive FHA11KRASG12V-TCR IV
Interventions
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Bendamustine
Receive IV
Intervention Type
DRUG
Biopsy
Undergo tissue biopsy
Intervention Type
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
Intervention Type
PROCEDURE
Computed Tomography
Undergo CT
Intervention Type
PROCEDURE
Cyclophosphamide
Receive IV
Intervention Type
DRUG
Echocardiography
Undergo ECHO
Intervention Type
PROCEDURE
Fludarabine
Receive IV
Intervention Type
DRUG
Leukapheresis
Undergo leukapheresis
Intervention Type
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
Intervention Type
PROCEDURE
Multigated Acquisition Scan
Undergo MUGA
Intervention Type
PROCEDURE
Positron Emission Tomography
Undergo PET
Intervention Type
PROCEDURE
T-cell Receptor-engineered T-cells
Receive FHA11KRASG12V-TCR IV
Intervention Type
BIOLOGICAL
Other Intervention Names
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SDX-105
BIOPSY_TYPE
Bx
Biological Sample Collection
Biospecimen Collected
Specimen Collection
CAT
CAT Scan
Computed Axial Tomography
Computerized Axial Tomography
Computerized axial tomography (procedure)
Computerized Tomography
CT
CT Scan
tomography
(-)-Cyclophosphamide
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
Carloxan
Ciclofosfamida
Ciclofosfamide
Cicloxal
Clafen
Claphene
CP monohydrate
CTX
CYCLO-cell
Cycloblastin
Cycloblastine
Cyclophospham
Cyclophosphamid monohydrate
Cyclophosphamide Monohydrate
Cyclophosphamidum
Cyclophosphan
Cyclophosphane
Cyclophosphanum
Cyclostin
Cyclostine
Cytophosphan
Cytophosphane
Cytoxan
Fosfaseron
Genoxal
Genuxal
Ledoxina
Mitoxan
Neosar
Revimmune
Syklofosfamid
WR- 138719
EC
Fluradosa
Leukocytopheresis
Therapeutic Leukopheresis
Magnetic Resonance
Magnetic resonance imaging (procedure)
Magnetic Resonance Imaging Scan
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
MR
MR Imaging
MRI
MRI Scan
NMR Imaging
NMRI
Nuclear Magnetic Resonance Imaging
Blood Pool Scan
Equilibrium Radionuclide Angiography
Gated Blood Pool Imaging
Gated Heart Pool Scan
MUGA
MUGA Scan
Multi-Gated Acquisition Scan
Radionuclide Ventriculogram Scan
Radionuclide Ventriculography
RNVG
SYMA Scanning
Synchronized Multigated Acquisition Scanning
RNV Scan
Medical Imaging, Positron Emission Tomography
PET
PET Scan
Positron emission tomography (procedure)
Positron Emission Tomography Scan
Positron-Emission Tomography
proton magnetic resonance spectroscopic imaging
PT
T-cell Receptor-engineered T Cells
T-cell Receptor-engineered T-lymphocytes
TCR T Cells
TCR T-cells
TCR-engineered T-cells
TCR-modified T Cells
FH-A11KRASG12V-TCR
AFNT-111
Eligibility Criteria
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Inclusion Criteria
* LEUKAPHERESIS: Diagnosis of metastatic solid tumor
* LEUKAPHERESIS: Tissue confirmation of solid tumor. Confirmation of diagnosis must be or have been performed by internal pathology review of archival biopsy material or other pathologic material at Fred Hutch/University of Washington Cancer Consortium (UWMC)
* LEUKAPHERESIS: HLA-A\*11:01 confirmed through HLA typing at a clinically accredited laboratory
* LEUKAPHERESIS: Previously documented KRASG12V mutation in tumor or plasma cell-free deoxyribonucleic acid (cfDNA) specimens by polymerase chain reaction (PCR) or next-generation sequencing (NGS) test
* LEUKAPHERESIS: Measurable disease by RECIST 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm, unless lymph node in which case short axis must be ≥ 15 mm. Baseline imaging (for example, diagnostic CT chest/abdomen/pelvis and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) if clinically indicated, must be obtained within 8 weeks of the first planned T cell infusion. MRI can be substituted for CT in participants unable to have CT contrast
* LEUKAPHERESIS: Participants must be willing to undergo tumor biopsy for research purposes if safe and feasible at baseline (prior to first T cell infusion), 2-3 weeks after the first T cell infusion, and approximately 2 weeks +/- 1 week after the 2nd infusion (if applicable), if safe and feasible (these time windows may vary due to manufacturing or clinical reasons). Should there be no tumor tissue that is accessible for biopsy, subjects will still be considered for participation, at the discretion of the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons, biopsies may be cancelled or rescheduled. Patients can also refuse biopsies at any time after enrollment
* LEUKAPHERESIS: Participants must be at least two weeks or five half-lives (for small molecules) from last systemic treatment: At least 2 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, vaccines), or chemotherapy cancer treatment. At least five half-lives must have passed from treatment with small molecules or other investigational agents. There is no washout period for radiation, so long as radiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates and denosumab are permitted
* LEUKAPHERESIS: Participants must have progressed on or be intolerant to at least one lines of prior therapy including any targeted therapies indicated for subjects with each of the tumor types eligible to enroll, as applicable
* LEUKAPHERESIS: Patients with solid tumors harboring targetable molecular alterations including but not limited to EGFR mutations, ALK, ROS, NTRK fusions, microsatellite instability (MSI)-high, tumor mutational burden (TMB) high, BRAF v600 mutations, HER2 amplifications, must have been treated or refused treatment with applicable targeted therapies, as applicable
* LEUKAPHERESIS: Fertile male and female participants must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last A11KRASG12V-TCR infusion
* LEUKAPHERESIS: 18 years or older at the time of enrollment
* LEUKAPHERESIS: Capable of understanding and providing a written informed consent
* LEUKAPHERESIS: Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
* No uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
* LEUKAPHERESIS: No uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
* LEUKAPHERESIS: Renal: Creatinine clearance \>= 50 ml/min by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or 24-hour urine clearance
* LEUKAPHERESIS: Hepatic: Total bilirubin \< 2.0 mg/dL
* LEUKAPHERESIS: Hepatic: Aspartate transferase (AST) and alanine transaminase (ALT) \< 5x upper limit of normal (ULN)
* LEUKAPHERESIS: Hepatic: Participants with suspected Gilbert syndrome may be included if total bilirubin (Bili) \> 3 mg/dL but no other evidence of hepatic dysfunction
* LEUKAPHERESIS: Cardiac: Participants 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and LVEF must be \>= 35%. Cardiac evaluation for other participants is at the discretion of the treating physician
* LEUKAPHERESIS: Hematologic: Absolute neutrophil count (ANC) \>= 1000 cells/ mm\^3
* LEUKAPHERESIS: Nutrition: Albumin \>= 3 g/dL
* START OF TREATMENT: Measurable disease by RECIST 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm, unless lymph node in which case short axis must be \>= 15 mm. Baseline imaging (for example, diagnostic CT chest/abdomen/pelvis and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) must be obtained within 8 weeks of the first planned T cell infusion. MRI can be substituted for CT in participants unable to have CT contrast
* START OF TREATMENT: Participants must be willing to undergo tumor biopsy for research purposes if safe and feasible at baseline (prior to first T cell infusion), 2-3 weeks after the first T cell infusion, and approximately 2 weeks +/- 1 week after the 2nd infusion (if applicable), if safe and feasible (these windows may vary due to manufacturing or clinical reasons). Should there be no tumor tissue that is accessible for biopsy, subjects will still be considered for participation, at discretion of the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons, biopsies may be cancelled or rescheduled
* START OF TREATMENT: Participants must be at least two weeks from last systemic treatment: At least 2 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, vaccines), or chemotherapy cancer treatment. At least five half-lives must have passed from treatment with small molecules or other investigational agents. There is no washout period for radiation, so long as radiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates and denosumab are permitted
* START OF TREATMENT: ECOG performance status of =\< 1
* START OF TREATMENT: Renal: Creatinine clearance \>= 50 ml/min by CKD-EPI or 24-hour urine clearance
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: Hepatic: Total bilirubin \< 2.0 mg/dL
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: AST and ALT \< 5x upper limit of normal (ULN)
* START OF TREATMENT: Participants with suspected Gilbert syndrome may be included if total Bili \> 3 mg/dl but no other evidence of hepatic dysfunction
* START OF TREATMENT: Pulmonary: =\< grade 1 dyspnea and oxygen saturation of arterial blood (SaO2) \>= 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, participants with forced expiratory volume in the first second (FEVI) \>= 50% of predicted and diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected) \>= 40% of predicted will be eligible
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: Hematologic: ANC \>= 1000 cells/ mm\^3
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: Nutrition: Albumin \>= 3 g/dL
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: Participants with a history of chronic obstructive pulmonary disease (COPD), emphysema, or greater than 30 pack year smoking history should undergo PFTs and meet the following criteria:
* FEVI \>= 50% of predicted and DLCO (corrected) \>= 40% of predicted will be eligible
* LEUKAPHERESIS: Tissue confirmation of solid tumor. Confirmation of diagnosis must be or have been performed by internal pathology review of archival biopsy material or other pathologic material at Fred Hutch/University of Washington Cancer Consortium (UWMC)
* LEUKAPHERESIS: HLA-A\*11:01 confirmed through HLA typing at a clinically accredited laboratory
* LEUKAPHERESIS: Previously documented KRASG12V mutation in tumor or plasma cell-free deoxyribonucleic acid (cfDNA) specimens by polymerase chain reaction (PCR) or next-generation sequencing (NGS) test
* LEUKAPHERESIS: Measurable disease by RECIST 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm, unless lymph node in which case short axis must be ≥ 15 mm. Baseline imaging (for example, diagnostic CT chest/abdomen/pelvis and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) if clinically indicated, must be obtained within 8 weeks of the first planned T cell infusion. MRI can be substituted for CT in participants unable to have CT contrast
* LEUKAPHERESIS: Participants must be willing to undergo tumor biopsy for research purposes if safe and feasible at baseline (prior to first T cell infusion), 2-3 weeks after the first T cell infusion, and approximately 2 weeks +/- 1 week after the 2nd infusion (if applicable), if safe and feasible (these time windows may vary due to manufacturing or clinical reasons). Should there be no tumor tissue that is accessible for biopsy, subjects will still be considered for participation, at the discretion of the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons, biopsies may be cancelled or rescheduled. Patients can also refuse biopsies at any time after enrollment
* LEUKAPHERESIS: Participants must be at least two weeks or five half-lives (for small molecules) from last systemic treatment: At least 2 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, vaccines), or chemotherapy cancer treatment. At least five half-lives must have passed from treatment with small molecules or other investigational agents. There is no washout period for radiation, so long as radiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates and denosumab are permitted
* LEUKAPHERESIS: Participants must have progressed on or be intolerant to at least one lines of prior therapy including any targeted therapies indicated for subjects with each of the tumor types eligible to enroll, as applicable
* LEUKAPHERESIS: Patients with solid tumors harboring targetable molecular alterations including but not limited to EGFR mutations, ALK, ROS, NTRK fusions, microsatellite instability (MSI)-high, tumor mutational burden (TMB) high, BRAF v600 mutations, HER2 amplifications, must have been treated or refused treatment with applicable targeted therapies, as applicable
* LEUKAPHERESIS: Fertile male and female participants must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last A11KRASG12V-TCR infusion
* LEUKAPHERESIS: 18 years or older at the time of enrollment
* LEUKAPHERESIS: Capable of understanding and providing a written informed consent
* LEUKAPHERESIS: Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
* No uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
* LEUKAPHERESIS: No uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
* LEUKAPHERESIS: Renal: Creatinine clearance \>= 50 ml/min by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or 24-hour urine clearance
* LEUKAPHERESIS: Hepatic: Total bilirubin \< 2.0 mg/dL
* LEUKAPHERESIS: Hepatic: Aspartate transferase (AST) and alanine transaminase (ALT) \< 5x upper limit of normal (ULN)
* LEUKAPHERESIS: Hepatic: Participants with suspected Gilbert syndrome may be included if total bilirubin (Bili) \> 3 mg/dL but no other evidence of hepatic dysfunction
* LEUKAPHERESIS: Cardiac: Participants 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and LVEF must be \>= 35%. Cardiac evaluation for other participants is at the discretion of the treating physician
* LEUKAPHERESIS: Hematologic: Absolute neutrophil count (ANC) \>= 1000 cells/ mm\^3
* LEUKAPHERESIS: Nutrition: Albumin \>= 3 g/dL
* START OF TREATMENT: Measurable disease by RECIST 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm, unless lymph node in which case short axis must be \>= 15 mm. Baseline imaging (for example, diagnostic CT chest/abdomen/pelvis and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) must be obtained within 8 weeks of the first planned T cell infusion. MRI can be substituted for CT in participants unable to have CT contrast
* START OF TREATMENT: Participants must be willing to undergo tumor biopsy for research purposes if safe and feasible at baseline (prior to first T cell infusion), 2-3 weeks after the first T cell infusion, and approximately 2 weeks +/- 1 week after the 2nd infusion (if applicable), if safe and feasible (these windows may vary due to manufacturing or clinical reasons). Should there be no tumor tissue that is accessible for biopsy, subjects will still be considered for participation, at discretion of the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons, biopsies may be cancelled or rescheduled
* START OF TREATMENT: Participants must be at least two weeks from last systemic treatment: At least 2 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, vaccines), or chemotherapy cancer treatment. At least five half-lives must have passed from treatment with small molecules or other investigational agents. There is no washout period for radiation, so long as radiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates and denosumab are permitted
* START OF TREATMENT: ECOG performance status of =\< 1
* START OF TREATMENT: Renal: Creatinine clearance \>= 50 ml/min by CKD-EPI or 24-hour urine clearance
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: Hepatic: Total bilirubin \< 2.0 mg/dL
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: AST and ALT \< 5x upper limit of normal (ULN)
* START OF TREATMENT: Participants with suspected Gilbert syndrome may be included if total Bili \> 3 mg/dl but no other evidence of hepatic dysfunction
* START OF TREATMENT: Pulmonary: =\< grade 1 dyspnea and oxygen saturation of arterial blood (SaO2) \>= 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, participants with forced expiratory volume in the first second (FEVI) \>= 50% of predicted and diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected) \>= 40% of predicted will be eligible
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: Hematologic: ANC \>= 1000 cells/ mm\^3
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: Nutrition: Albumin \>= 3 g/dL
* Exceptions may be at the discretion of the PI to allow participants with organ function affected by their organ-specific tumor involvement
* START OF TREATMENT: Participants with a history of chronic obstructive pulmonary disease (COPD), emphysema, or greater than 30 pack year smoking history should undergo PFTs and meet the following criteria:
* FEVI \>= 50% of predicted and DLCO (corrected) \>= 40% of predicted will be eligible
Exclusion Criteria
* LEUKAPHERESIS: Prior solid organ transplant or allogeneic hematopoietic stem cell transplant: Kidney transplant participants will be considered on a case-by-case basis requiring discussion with PI. If the participant has had a kidney transplant, participant must have dialysis access, dialysis plan, supportive nephrologist, willingness to stop transplant immunosuppression, and express understanding that rejection is possible outcome. Dialysis or costs related to transplant kidney will not be supported by the study. Participants having had any other solid organ transplants will be excluded, as will those with any history of allogeneic hematopoietic stem cell transplant
* START OF TREATMENT: Pregnancy, breastfeeding, or expecting to conceive or father children for the duration of the trial through 4 months after last T-cell infusion. Participants of childbearing potential must have a negative serum pregnancy test within the 2 weeks (14 days) preceding T cell infusion. Childbearing potential is defined as women who have not been surgically sterilized and who are not post-menopausal (free of menses for at least 1 year)
* START OF TREATMENT: Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by PI
* START OF TREATMENT: Corticosteroid therapy at a dose equivalent of \> 0.5 mg/kg of prednisone per day. The following treatments are permitted: intranasal, inhaled, topical, or local steroid applications; systemic corticosteroids at physiologic doses equivalent to no more than \> 0.5 mg/kg/day prednisone; steroids as premedication for contrast dye allergy
* START OF TREATMENT: Concurrent use of other investigational anti-cancer agents
* START OF TREATMENT: Active uncontrolled infection: Human immunodeficiency virus (HIV) positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \> 500 cells/mm\^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication
* START OF TREATMENT: Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* START OF TREATMENT: Untreated brain metastases: Participants with small asymptomatic brain metastases (\< 1 cm) or those with brain metastases previously treated and controlled with surgery or radiotherapy will be considered for inclusion at discretion of PI, so long as all other eligibility criteria are met
* START OF TREATMENT: Active treatment for prior immune related adverse event to any immunotherapy: Participants receiving ongoing treatment for prior serious immune-related adverse events are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of up to 0.5mg/kg/day prednisone per day, unless otherwise approved by PI
* START OF TREATMENT: Other medical, social, or psychiatric factor that interferes with medical appropriateness and/or ability to comply with study, as determined by the PI
* START OF TREATMENT: Known allergic reactions to any of the components of study treatments
* START OF TREATMENT: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
* START OF TREATMENT: Pregnancy, breastfeeding, or expecting to conceive or father children for the duration of the trial through 4 months after last T-cell infusion. Participants of childbearing potential must have a negative serum pregnancy test within the 2 weeks (14 days) preceding T cell infusion. Childbearing potential is defined as women who have not been surgically sterilized and who are not post-menopausal (free of menses for at least 1 year)
* START OF TREATMENT: Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by PI
* START OF TREATMENT: Corticosteroid therapy at a dose equivalent of \> 0.5 mg/kg of prednisone per day. The following treatments are permitted: intranasal, inhaled, topical, or local steroid applications; systemic corticosteroids at physiologic doses equivalent to no more than \> 0.5 mg/kg/day prednisone; steroids as premedication for contrast dye allergy
* START OF TREATMENT: Concurrent use of other investigational anti-cancer agents
* START OF TREATMENT: Active uncontrolled infection: Human immunodeficiency virus (HIV) positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \> 500 cells/mm\^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication
* START OF TREATMENT: Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* START OF TREATMENT: Untreated brain metastases: Participants with small asymptomatic brain metastases (\< 1 cm) or those with brain metastases previously treated and controlled with surgery or radiotherapy will be considered for inclusion at discretion of PI, so long as all other eligibility criteria are met
* START OF TREATMENT: Active treatment for prior immune related adverse event to any immunotherapy: Participants receiving ongoing treatment for prior serious immune-related adverse events are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of up to 0.5mg/kg/day prednisone per day, unless otherwise approved by PI
* START OF TREATMENT: Other medical, social, or psychiatric factor that interferes with medical appropriateness and/or ability to comply with study, as determined by the PI
* START OF TREATMENT: Known allergic reactions to any of the components of study treatments
* START OF TREATMENT: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Affini-T Therapeutics, Inc.
INDUSTRY
Sponsor Role
collaborator
National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Fred Hutchinson Cancer Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Elena Chiorean
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Fred Hutch Intake
Role: primary
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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RG1123135
Identifier Type: -
Identifier Source: org_study_id
NCI-2023-06287
Identifier Type: REGISTRY
Identifier Source: secondary_id
20048
Identifier Type: OTHER
Identifier Source: secondary_id