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Tumor SkinPhase 1/2Agni-01NCT06060613

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

A Phase 1/2 study testing OBX-115 in people with Tumor Skin and Metastatic Melanoma, run by Obsidian Therapeutics, Inc. at 14 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumor Skin, Metastatic Melanoma, Melanoma
What is being tested?
OBX-115
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
14 sitesin 2 countries
Study dates
25 Oct 2023to 30 Jun 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be 18 years of age or older at the time of signing the informed consent.
  • Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC).
  • Cohort and indication specific criteria as follows:
  • 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.
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  • 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).
  • Participants who received PD-1/PD-L1 inhibitor-based therapy in the adjuvant or neoadjuvant setting and whose disease relapsed or progressed to metastatic disease within 6 months of their last systemic PD-1/PD-L1 treatment are eligible without requiring additional treatment in the metastatic setting.
  • Participants who experienced disease progression following a prior cytotoxic chemotherapy-based regimen may have received no more than one additional chemotherapy-containing regimen. However, participants must not have had disease progression while receiving this second-chemotherapy containing regimen.
  • 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 (neo)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.
  • 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 prior to tumor procurement.) 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 (neo)adjuvant treatment (primary ICI resistant) are not eligible.
  • Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.
  • After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months.
  • Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE]).
  • 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.
  • Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements.
  • Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.
  • Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.

Who cannot join

  • Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).
  • 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.
  • Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.
  • Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.
  • Participant has any form of primary or acquired immunodeficiency.
  • Participant has a history of hypersensitivity to any component of the study intervention.
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  • Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).
  • Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.
  • Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent.
  • Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).
  • 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.

Trial locations and contacts

14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Obsidian Therapeutics contact

781-202-5423

OBX115-2301TRIAL@OBSIDIANTX.COM

14 sites in 2 countries

United States13 sites, 12 recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Active, not recruiting

  • M.D. Anderson Cancer Center (Melanoma/NSCLC)

    Houston, Texas, 77030

    Steffy Jose, SJose3@mdanderson.org

    Rodabe Amaria, MD

    Recruiting

  • The Angeles Clinic and Research Institute (Melanoma)

    Los Angeles, California, 90025

    Saba Mukarram, SMukarram@theangelesclinic.org

    Omid Hamid, MD

    Recruiting

  • USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)

    Los Angeles, California, 90033

    Sandy Tran, 323-865-3935, sandy.tran@med.usc.edu

    Gino In, MD

    Recruiting

  • James Graham Brown Cancer Center (Melanoma/NSCLC)

    Louisville, Kentucky, 40202

    Melissa B. Hall, Mmbaro01@louisville.edu

    Jason Chesney, MD, PhD

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Kendal Payne, krp127@med.miami.edu

    Jose Lutzky, MD

    Recruiting

  • Memorial Sloan Kettering (Melanoma/NSCLC)

    New York, New York, 10065

    Melanoma, 6464979067

    NSCLC, 6464979163

    Recruiting

  • Advent Health Orlando

    Orlando, Florida, 32803

    Karin Donaldson, Karin.Donaldson@Adventhealth.com

    Sajeve Thomas, MD

    Recruiting

  • Orlando Health Cancer Institute (Melanoma/NSCLC)

    Orlando, Florida, 32806

    Danielle Ramos, 321-841-6764, danielle.ramos1@orlandohealth.com

    Tirrell T. Johnson, MD

    Recruiting

  • Allegheny Research Institute (Melanoma/NSCLC)

    Pittsburgh, Pennsylvania, 15224

    Lindsay Brown, lindsey.brown@ahn.org

    Deanna Huffman, DO

    Recruiting

  • Stanford Cancer Institute (Melanoma/NSCLC)

    Stanford, California, 94305

    Samantha Lam, 650-736-3054, samalam@stanford.edu

    Allison Betof, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    ICETtrials@moffitt.org

    Ben Creelan, MD

    Recruiting

  • Banner Health

    Tucson, Arizona, 85719

    Kylie Ketchum, Kylie.Ketchum@bannerhealth.com

    Yazan Samhouri, MD

    Recruiting

Other trials in United States

Australia1 site, 1 recruiting

  • Melanoma Institute of Australia

    Wollstonecraft, New South Wales, 2065

    Raina Faraz, Rania.Faraz@melanoma.org.au

    Georgina Long, MD

    Recruiting

Other trials in Australia

About this study

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

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

Read the detailed description

Primary Objective (Phase 1):

  • Assess the safety and tolerability of OBX-115 regimen

Primary Objective (Phase 2):

  • Evaluate preliminary efficacy of OBX-115 regimen as measured by Blinded Independent Central Review (BICR) using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Cohort 3)
  • Evaluate preliminary efficacy of OBX-115 regimen as measured by the investigator using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Cohorts 1, 2, 4)

Secondary (Phase 1):

  • Assess preliminary efficacy of OBX-115 regimen by evaluating ORR

Secondary (Phase 2):

  • Evaluate safety and tolerability of OBX 115 based on the collected AE data

Secondary (both Phase 1 and Phase 2):

  • Evaluate duration of response (DOR): To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by BICR until disease progression or death due to cancer (Phase 2 Cohort 3).
  • Evaluate duration of response (DOR): To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to cancer (Phase 1 and Phase 2 Cohorts 1, 2, and 4).
  • Evaluate disease control rate (DCR): To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) for at least 4 weeks per RECIST v1.1 as assessed by BICR (Phase 2 Cohort 3).
  • Evaluate disease control rate (DCR): To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) for at least 4 weeks per RECIST v1.1 as assessed by the investigator (Phase 1 and Phase 2 Cohorts 1, 2, and 4).
  • Evaluate progression-free survival (PFS): To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v1.1 as assessed by BICR or death due to any cause (Phase 2 Cohort 3).
  • Evaluate progression-free survival (PFS): To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v1.1 as assessed by the investigator or death due to any cause (Phase 1 and Phase 2 Cohorts 1, 2, and 4).
  • Evaluate overall survival (OS): To evaluate the time from the date of OBX-115 infusion to death due to any cause
  • Evaluate feasibility of the manufacturing process: Evaluated as the proportion of OBX-115 products initiated for manufacturing that pass release criteria for infusion.
Being tested
OBX-115
Keywords
Adoptive cell therapy, Tumor Infiltrating Lymphocytes, TIL, Melanoma, Lung Cancer
Medical subject headings
Skin Neoplasms, Melanoma, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OBX-115Biological

    A tumor sample is obtained from each participant for autologous OBX-115 manufacture.

    After lymphodepletion including cyclophosphamide and fludarabine, participant will receive OBX-115 infusion, followed by short courses of acetazolamide.

Study groups in NCT06060613
Study groupRoleWhat they receive
Participants with advanced solid tumorsExperimentalParticipants will receive conditioning therapy prior to administration of OBX-115 regimen.
Receives: Biological: OBX-115

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and nature of dose-limiting toxicities (DLTs)

    • Incidence of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 infusion (Phase 1).

    Measured: 28 Days

  2. The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1

    • The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR) from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 2 Cohort 3)

    Measured: 2 years

  3. The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1

    • The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 2 Cohort 1, 2, and 4)

    Measured: 2 years

Secondary outcomes (2)

  1. The proportion of participants who have a confirmed CR or PR per RECIST v1.1

    • The proportion of participants who have a confirmed CR or PR per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 1)

    Measured: 2 years

  2. Incidence of AEs

    • Incidence of treatment-emergent adverse events (TEAEs), including SAEs, study intervention related AEs, and AEs leading to early discontinuation of study intervention or withdrawal from the Assessment Period or death up to 2 years after initiation of study intervention

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start25 Oct 2023
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single group assignment
Masking
None (open label)
Enrolment
254 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06060613
Sponsor's protocol ID
OBX115-23-01
Acronym
Agni-01
Status last verified
Oct 2026
First submitted
22 Sep 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amaria RN, Chesney JA, Betof AS, In GK, Shoushtari AN, Johnson TT, Hamid O, Samhouri Y, Davies MA, Tawbi HA, Glitza Oliva IC, Aksoy BA, Kelly AM, Duan R, Prabhakar P, Ramsingh G, Jagasia M, Hari P. Regulatable membrane-bound IL-15 engineered TIL cell therapy for immune checkpoint inhibitor-resistant advanced melanoma: pooled analysis of phase 1 and 1/2 trials. Nat Med. 2026 Nov 3. doi: 10.1038/s41591-026-04743-6. Online ahead of print.

    PubMed 42977756

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OBX-115 in people with Tumor Skin and Metastatic Melanoma, run by Obsidian Therapeutics, Inc. at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Obsidian Therapeutics (781-202-5423, OBX115-2301TRIAL@OBSIDIANTX.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and nature of dose-limiting toxicities (DLTs) (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06060613, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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