Immune cells supercharged to fight advanced cancers
NCT ID NCT06060613
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 4 times
Summary
This study tests an experimental treatment called OBX-115 for people with advanced melanoma or non-small cell lung cancer that has spread or stopped responding to standard therapy. OBX-115 uses a patient's own immune cells (tumor-infiltrating lymphocytes) that are modified in the lab to include a protein (IL15) that helps them survive and attack tumors. The goal is to see if this approach can shrink tumors safely. About 208 adults will take part in this early-phase trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 208 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 or relapsed refractory metastatic non-small cell lung cancer (NSCLC). 3. Cohort and indication specific criteria as follows: 1. Phase 1 and Phase 2 Cohort 1 (enrollment complete): * Participants with unresectable or metastatic melanoma must have 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. 2. Phase 1 and Phase 2 Cohort 2 (recruiting): * 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). * Participant must not have been exposed to any second line cytotoxic chemotherapy if they have already received cytotoxic chemotherapy in the first line setting. 3. Phase 2 Cohort 3 (recruiting): * Participants with unresectable or metastatic melanoma must have 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 targetable BRAF mutations are not required to have received prior BRAF inhibitors. Participants must not have disease progression on a BRAF/MEK inhibitor that was given as the most recent line of therapy. 4. Phase 2 Cohort 4 (recruiting): * Participants with frontline unresectable or metastatic melanoma. * Participants may have received up to 2 doses of system therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody-based treatment of unresectable metastatic melanoma (but must not have known clinical progression.) Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy; however, participants whose disease progressed within 12 weeks after the last dose of the PD-1/PD-L1 blocking antibody given as adjuvant treatment (primary ICI resistant) are not eligible. 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. Exclusion Criteria: 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 that have been treated, if clinically indicated. Asymptomatic brain metastases that are equivocal or too small to warrant treatment may not be counted towards the above set limits upon discussion and agreement from the Medical Monitor. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Allegheny Research Institute (Melanoma/NSCLC)
RECRUITINGPittsburgh, Pennsylvania, 15224, United States
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James Graham Brown Cancer Center (Melanoma/NSCLC)
RECRUITINGLouisville, Kentucky, 40202, United States
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M.D. Anderson Cancer Center (Melanoma/NSCLC)
RECRUITINGHouston, Texas, 77030, United States
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Melanoma Institute of Australia
RECRUITINGWollstonecraft, New South Wales, 2065, Australia
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Memorial Sloan Kettering (Melanoma/NSCLC)
RECRUITINGNew York, New York, 10065, United States
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Orlando Health Cancer Institute (Melanoma/NSCLC)
RECRUITINGOrlando, Florida, 32806, United States
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Stanford Cancer Institute (Melanoma/NSCLC)
RECRUITINGStanford, California, 94305, United States
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The Angeles Clinic and Research Institute (Melanoma)
RECRUITINGLos Angeles, California, 90025, United States
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The Ohio State University
ACTIVE_NOT_RECRUITINGColumbus, Ohio, 43210, United States
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USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)
RECRUITINGLos Angeles, California, 90033, United States
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