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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05108623
Recruitment Status : Recruiting
First Posted : November 5, 2021
Last Update Posted : October 24, 2022
Sponsor:
Information provided by (Responsible Party):
MiNK Therapeutics

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Tumor, Solid Drug: agenT-797 Drug: Approved ICIs Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 28, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Monotherapy with agenT-797
3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion.
 Drug: agenT-797
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.
Experimental: Part 2: agenT-797 in Combination with approved ICIs
Single 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
 Drug: agenT-797
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.

Drug: Approved ICIs
Nivolumab and pembrolizumab


Outcome Measures
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Primary Outcome Measures :
  1. Number Of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline through 12 months ]
    This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).

  2. Number Of Adverse Events (AEs) By The Dose Of iNKT Cell Therapy [ Time Frame: Baseline through 12 months ]
    This will be determined according to the NCI CTCAE v5.0.

  3. Number Of TEAEs By The Dose Of iNKT Cell Therapy [ Time Frame: Baseline through 12 months ]
    This will be determined according to the NCI CTCAE v5.0.

  4. Severity Grade Of AEs By Dose Of iNKT Cell Therapy [ Time Frame: Baseline through 12 months ]
    This will be determined according to the NCI CTCAE v5.0.

  5. Number Of Dose-limiting Toxicities [ Time Frame: Baseline through first 14 days after administration ]

Secondary Outcome Measures :
  1. Persistence Of agenT-797 In Peripheral Blood Samples [ Time Frame: 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 ]
    This will be measured as a length of time, through collection of peripheral blood mononuclear cells and analysis by flow cytometry.

  2. Objective Response Rate (ORR) [ Time Frame: Up to 12 months ]
    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.

  3. Duration Of Response (DOR) [ Time Frame: Up to 12 months ]
    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.

  4. Progression-free Survival (PFS) [ Time Frame: Up to 12 months ]
    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.

  5. Incidence Of Panel-reactive Antibody [ Time Frame: 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 [ Time Frame: 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05108623


Contacts
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Contact: MiNK Therapeutics Clinical Trial Information 781-674-4265 clinicaltrialinfo@agenusbio.com

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Michael Haas    312-505-9500    michael.haas@med.usc.edu   
Principal Investigator: Anthony El-Khoueiry, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Dan Nguyen       dan.n.nguyen@cuanschutz.edu   
Principal Investigator: Breelyn Wilky, MD         
United States, Kentucky
Norton Cancer Health Recruiting
Louisville, Kentucky, United States, 40241
Contact: Ben Orem    502-629-2500 ext 19460      
Principal Investigator: John Hamm, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Denise Graham       dgraham2@bidmc.harvard.edu   
Principal Investigator: David Einstein, MD         
United States, New York
Weill Cornell Medicine Not yet recruiting
New York, New York, United States, 10022
Contact: Helen Barkhudarayan    646-962-8215    jcto@weill.cornell.edu   
Principal Investigator: Koen van Besien, MD         
United States, Ohio
University of Cincinnati Cancer Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Madison Duan    513-584-7824    duanm@ucmail.uc.edu   
Principal Investigator: Trisha Wise-Draper, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: An Nguyen    425-224-7602    an.k.nguyen@providence.org   
Principal Investigator: Rachel Sanborn, MD         
United States, Rhode Island
LifeSpan - Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Ginal Johnson    401-444-4226    gjohnson@Lifespan.org   
Principal Investigator: Benedito Carneiro, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Nurse Navigator Team    615-329-7274      
Principal Investigator: Benjamin Garmezy, MD         
Sponsors and Collaborators
MiNK Therapeutics
Investigators
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Study Director: Medical Director MiNK Therapeutics
More Information
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Additional Information:

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Responsible Party: MiNK Therapeutics
ClinicalTrials.gov Identifier: NCT05108623    
Other Study ID Numbers: 2021-1306
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MiNK Therapeutics:
Tumor
Solid Tumor
Immunotherapy
iNKT cells
Additional relevant MeSH terms:
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Neoplasms