ACTIVE_NOT_RECRUITING

Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors

Conditions

HNSCC Melanoma Gynecologic Cancer Colorectal Cancer Lung Cancer Urogenital Cancer Solid Malignancies Adoptive Cell Therapy (ACT)Cancer T cell PD-1

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The subject of this study is the adoptive transfer of selected autologous tumor infiltrating lymphocytes (TIL) after in vitro expansion for the treatment of solid tumor malignancies. The TIL selection process is based on evidence showing that CD8+ TIL which co-express both CD39 and CD103 harbor the bulk of tumor-reactivity and that the remaining CD8 TIL is mainly composed of non-tumor reactive bystander cells. All of the expanded TIL that are produced (1-40 billion are expected) will be delivered in the form of a cell suspension to the participants by intravenous infusion. It is proposed that these selected TIL will produce a more potent and efficacious treatment of late-stage cancer.

Official Title

Phase I Randomized Open Label Trial Investigating Adoptive Transfer of CD39+CD103+CD8+ Tumor-isolated T Cells (AGX148) Alone or Combined With siRNA Modulation of PD-1 (AGX148/PH-762) in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2023-06-19

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05902520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* Active brain metastases or leptomeningeal metastases. Participants with brain metastases are eligible if these have been treated and there is no MRI evidence of progression for at least 4 weeks after treatment is complete. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (\> 10 mg/day prednisone equivalents). Stable doses of anticonvulsants are allowed. Treatment for CNS metastases may include stereotactic radiosurgery (e.g. Gamma Knife, Cyber Knife, or equivalent) or neurosurgical resection. Patients who received whole brain radiation therapy are not eligible. * Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator, would preclude the patient from adhering to the protocol or would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results (e.g., a condition associated with diarrhea or acute diverticulitis). * Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or localized carcinoma of the prostate, cervix, or breast. * Participants with an active, known or suspected autoimmune disease requiring active treatment. Participants with type I diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Requirement for greater than physiological doses of corticosteroids (\> 10 mg daily prednisone equivalent) * Requirement for other immunosuppressive medications including but not limited to anti-TNF antibodies, mycophenylate mofetil and methotrexate. Inhaled, intra-nasal or topical steroids are permitted in the absence of active autoimmune disease. * History of organ or tissue transplant that requires systemic use of immune suppressive agents. * Active infection requiring systemic therapy within 14 days prior to enrollment. * Patients who have had chemotherapy, radiotherapy, biologics, other anti-neoplastic or investigational agents, and/or other antitumor treatment including immunotherapy within 2 weeks (14 days) of Day -5, or those who have not recovered from adverse events related to therapies administered more than 4 weeks (28 days) earlier, are not eligible to enroll. All adverse events related to prior therapy must have improved to grade 1 or better before study participation. * Focal radiotherapy (examples include SRS, Palliative or MRI-Linac) completed at least 2 weeks (14 days) prior to the first dose study treatment are permitted to enroll. * Patients with evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG are excluded. * DLCO, FEV1 or FEV1/FVC less than 65% of predicted due to clinically significant underlying pulmonary disease. For any pulmonary function test values less than predicted values, the PI will review, and document the patient's suitability for high-dose IL-2 therapy. * Allergy to any of the antibiotics used in the cell production. * Tumor harvest with no detectable DP CD8 TIL.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* Active brain metastases or leptomeningeal metastases. Participants with brain metastases are eligible if these have been treated and there is no MRI evidence of progression for at least 4 weeks after treatment is complete. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (\> 10 mg/day prednisone equivalents). Stable doses of anticonvulsants are allowed. Treatment for CNS metastases may include stereotactic radiosurgery (e.g. Gamma Knife, Cyber Knife, or equivalent) or neurosurgical resection. Patients who received whole brain radiation therapy are not eligible.
* Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator, would preclude the patient from adhering to the protocol or would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results (e.g., a condition associated with diarrhea or acute diverticulitis).
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or localized carcinoma of the prostate, cervix, or breast.
* Participants with an active, known or suspected autoimmune disease requiring active treatment. Participants with type I diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* Requirement for greater than physiological doses of corticosteroids (\> 10 mg daily prednisone equivalent)
* Requirement for other immunosuppressive medications including but not limited to anti-TNF antibodies, mycophenylate mofetil and methotrexate. Inhaled, intra-nasal or topical steroids are permitted in the absence of active autoimmune disease.
* History of organ or tissue transplant that requires systemic use of immune suppressive agents.
* Active infection requiring systemic therapy within 14 days prior to enrollment.
* Patients who have had chemotherapy, radiotherapy, biologics, other anti-neoplastic or investigational agents, and/or other antitumor treatment including immunotherapy within 2 weeks (14 days) of Day -5, or those who have not recovered from adverse events related to therapies administered more than 4 weeks (28 days) earlier, are not eligible to enroll. All adverse events related to prior therapy must have improved to grade 1 or better before study participation.
* Focal radiotherapy (examples include SRS, Palliative or MRI-Linac) completed at least 2 weeks (14 days) prior to the first dose study treatment are permitted to enroll.
* Patients with evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG are excluded.
* DLCO, FEV1 or FEV1/FVC less than 65% of predicted due to clinically significant underlying pulmonary disease. For any pulmonary function test values less than predicted values, the PI will review, and document the patient's suitability for high-dose IL-2 therapy.
* Allergy to any of the antibiotics used in the cell production.
* Tumor harvest with no detectable DP CD8 TIL.

Contacts and Locations

Study Locations (Sites)

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Collaborators and Investigators

Sponsor: AgonOx, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-19

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-06-19

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Solid Malignancies
Adoptive Cell Therapy (ACT)
Cancer
T cell
PD-1

Additional Relevant MeSH Terms

HNSCC
Melanoma
Gynecologic Cancer
Colorectal Cancer
Lung Cancer
Urogenital Cancer