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Tumor, SolidPhase 1NCT05108623

A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors

A Phase 1 study testing agenT-797 and Approved ICIs in people with Tumor, Solid, run by MiNK Therapeutics at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed/refractory (r/r) solid tumors, as well as define the recommended phase II dose in solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumor, Solid
What is being tested?
agenT-797 and Approved ICIs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
8 sitesUnited States
Study dates
28 Jan 2022to 2 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histological or cytological evidence of relapsed or refractory solid tumor malignancy for which no standard therapy is available or standard therapy has failed
  • Measurable disease per RECIST 1.1 as assessed by local site Investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
  • Part 2 only, participants must have progressed per Investigator assessment on pembrolizumab or nivolumab, and agree and are able to continue on the inhibitor(s) while on study
  • No other medical, surgical, or psychiatric condition (including active substance abuse) that would interfere with compliance to the protocol, as determined by the Principal Investigator

Who cannot join

  • Concurrent invasive malignancy
  • Brain and/or leptomeningeal metastases that are untreated or require current therapy
  • Prior radiotherapy within 2 weeks of start of study treatment

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45267

  • University of Southern California

    Los Angeles, California, 90033

  • Norton Cancer Health

    Louisville, Kentucky, 40241

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • LifeSpan - Rhode Island Hospital

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Study of the Safety, Tolerability and Preliminary Clinical Activity of Allogeneic Invariant Natural Killer T (iNKT) Cells (agenT-797) as a Single Agent and in Combination With Approved Immune Checkpoint Inhibitors in Patients With Relapsed/ Refractory Solid Tumors

This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed/refractory (r/r) solid tumors, as well as define the recommended phase II dose in solid tumors. This Phase 1 study will also explore the safety, tolerability, and preliminary clinical activity of agenT-797 in combination with approved immune checkpoint inhibitors (ICIs), including pembrolizumab and nivolumab, in participants with r/r solid tumors.

Conditions
Tumor, Solid
Being tested
agenT-797, Approved ICIs
Keywords
Tumor, Solid Tumor, Immunotherapy, iNKT cells
Medical subject headings
Neoplasms

What participants receive

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

  • agenT-797Drug

    agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo.

  • Approved ICIsDrug

    Nivolumab and pembrolizumab

Study groups in NCT05108623
Study groupRoleWhat they receive
Part 1: Monotherapy with agenT-797Experimental3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion.
Receives: Drug: agenT-797
Part 2: agenT-797 in Combination with approved ICIsExperimentalSingle prespecified dose of agenT-797 administered by IV infusion in combination with approved ICIs administered in accordance with manufacturer instructions and institutional guidelines as per standard of care
Receives: Drug: agenT-797; Drug: Approved ICIs

What is being measured

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

  1. Number Of Participants With Treatment-emergent Adverse Events (TEAEs)

    This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).

    Measured: Baseline through 12 months

  2. Number Of Adverse Events (AEs) By The Dose Of iNKT Cell Therapy

    This will be determined according to the NCI CTCAE v5.0.

    Measured: Baseline through 12 months

  3. Number Of TEAEs By The Dose Of iNKT Cell Therapy

    This will be determined according to the NCI CTCAE v5.0.

    Measured: Baseline through 12 months

  4. Severity Grade Of AEs By Dose Of iNKT Cell Therapy

    This will be determined according to the NCI CTCAE v5.0.

    Measured: Baseline through 12 months

  5. Number Of Dose-limiting Toxicities

    Measured: Baseline through first 14 days after administration

Secondary outcomes (6)

  1. Persistence Of agenT-797 In Peripheral Blood Samples

    This will be measured as a length of time, through collection of peripheral blood mononuclear cells and analysis by flow cytometry.

    Measured: Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0.5, 1, 2, and 4 hours after cell infusion), and on Days 2, 5, 8, 15, 22, and 29; Weeks 6, 8, and 12; and Months 6, 9, and 12

  2. Objective Response Rate (ORR)

    For solid tumors, this will be determined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), Prostate Cancer Working Group 3 (PCWG3) will be used.

    Measured: Up to 12 months

  3. Duration Of Response (DOR)

    For solid tumors, this will be determined per RECIST 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), PCWG3 will be used.

    Measured: Up to 12 months

  4. Progression-free Survival (PFS)

    For solid tumors, this will be determined per RECIST 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), PCWG3 will be used.

    Measured: Up to 12 months

  5. Incidence Of Panel-reactive Antibody

    Measured: Baseline/Day 1 (pre-infusion), Day 8, Day 15, Day 29, Week 8, Week 12, Month 6, and end of study visit (up to 12 months)

  6. Incidence Of Donor-specific Antibody

    Measured: Baseline/Day 1 (pre-infusion), Day 8, Day 15, Day 29, Week 8, Week 12, Month 6, and end of study visit (up to 12 months)

Timeline

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

  1. First posted5 Nov 2021
  2. Study start28 Jan 2022
  3. Primary completion2 Jan 2024
  4. Study completion2 Jan 2024

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05108623
Sponsor's protocol ID
2021-1306
Status last verified
Apr 2024
First submitted
12 Oct 2021
Last updated
24 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hadfield MJ, Safran H, Purbhoo MA, Grossman JE, Buell JS, Carneiro BA. Overcoming resistance to programmed cell death protein 1 (PD-1) blockade with allogeneic invariant natural killer T-cells (iNKT). Oncogene. 2024 Mar;43(10):758-762. doi: 10.1038/s41388-024-02948-y. Epub 2024 Jan 29.

    PubMed 38281989

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing agenT-797 and Approved ICIs in people with Tumor, Solid, run by MiNK Therapeutics at 8 sites in United States.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number Of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline through 12 months). The study lists 5 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 NCT05108623, 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 24 Apr 2024.

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