RECRUITING

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Conditions

Tumor Skin Metastatic Melanoma Melanoma Lung Cancer Metastatic Lung Cancer Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer Adoptive cell therapy Tumor Infiltrating Lymphocytes TIL

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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

This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.

Official Title

A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) in Participants with Advanced Solid Tumors

Quick Facts

Study Start:2023-10-25

Study Completion:2027-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06060613

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
1. Participant must be 18 years of age or older at the time of signing the informed consent. 2. Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma ore relapsed refractory metastatic non-small cell lung cancer (NSCLC). 3. Melanoma participant experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody. Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1/PD-L1 blocking antibody. Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and/or an approved targeted therapy for known molecular abnormalities if applicable to their disease). 4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation. 5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1. 6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months. 7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \[CTCAE\]). 8. Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery. 9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements. 10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count. 11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.	1. Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ). 2. Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are up to 1.5cm in diameter that have been treated, if clinically indicated. 3. Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation. 4. Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions. 5. Participant has any form of primary or acquired immunodeficiency. 6. Participant has a history of hypersensitivity to any component of the study intervention. 7. Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions). 8. Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed. 9. Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent. 10. Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD). 11. Participant has evidence of positive infectious disease screening and/or any active uncontrolled viral, bacterial, or fungal disease requiring ongoing systemic treatment or identified during screening.

Inclusion Criteria

Exclusion Criteria

1. Participant must be 18 years of age or older at the time of signing the informed consent.
2. Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma ore relapsed refractory metastatic non-small cell lung cancer (NSCLC).
3. Melanoma participant experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody. Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1/PD-L1 blocking antibody. Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and/or an approved targeted therapy for known molecular abnormalities if applicable to their disease).
4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.
5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.
6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months.
7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \[CTCAE\]).
8. Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery.
9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements.
10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.
11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.

1. Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).
2. Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are up to 1.5cm in diameter that have been treated, if clinically indicated.
3. Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.
4. Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.
5. Participant has any form of primary or acquired immunodeficiency.
6. Participant has a history of hypersensitivity to any component of the study intervention.
7. Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).
8. Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.
9. Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent.
10. Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).
11. Participant has evidence of positive infectious disease screening and/or any active uncontrolled viral, bacterial, or fungal disease requiring ongoing systemic treatment or identified during screening.

Contacts and Locations

Study Contact

Obsidian Therapeutics

CONTACT

781-202-5423

OBX115-2301TRIAL@OBSIDIANTX.COM

Study Locations (Sites)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Stanford Cancer Institute

Stanford, California, 94305

United States

Orlando Health Cancer Institute (Melanoma)

Orlando, Florida, 32806

United States

James Graham Brown Cancer Center (Melanoma/NSCLC)

Louisville, Kentucky, 40202

United States

Memorial Sloan Kettering (Melanoma/NSCLC)

New York, New York, 10065

United States

Allegheny Research Institute

Pittsburg, Pennsylvania, 15224

United States

Collaborators and Investigators

Sponsor: Obsidian Therapeutics, 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 Date2023-10-25

Study Completion Date2027-10-30

Study Record Updates

Study Start Date2023-10-25

Study Completion Date2027-10-30

Terms related to this study

Keywords Provided by Researchers

Adoptive cell therapy
Tumor Infiltrating Lymphocytes
TIL
Melanoma
Lung Cancer

Additional Relevant MeSH Terms

Tumor Skin
Metastatic Melanoma
Melanoma
Lung Cancer
Metastatic Lung Cancer
Non Small Cell Lung Cancer
Metastatic Non Small Cell Lung Cancer