Relapsed/Refractory Multiple MyelomaPhase 1NCT04754100
agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing agenT-797 in people with Relapsed/Refractory Multiple Myeloma, run by MiNK Therapeutics at 3 sites in United States.
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 or refractory multiple myeloma, as well as to define the recommended Phase 2 dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- agenT-797
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Mar 2021to 31 May 2023
- 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
- Relapsed/Refractory Multiple Myeloma
- Confirmed diagnosis and evidence of progressive disease or clinical relapse as defined by International Myeloma Working Group criteria and following prior therapy for multiple myeloma (MM)
- Relapsed or refractory MM requiring current treatment
- Previously failed ≥ 3 prior regimens (after at least 2 cycles of medication per regimen) and included at least 1 immunomodulatory drug, 1 proteasome inhibitor, and an anti-CD38 antibody agent
- Participants must have measurable disease as defined by at least 1 of the following:
- Serum M-protein ≥ 0.5 grams/deciliter (dL) by serum protein electrophoresis or for immunoglobulin A (IgA) myeloma, by quantitative IgA; or
Show all 10Show fewer
- Urinary M-protein excretion at least 200 milligrams (mg)/24 hours; or
- Serum free light chain whereby the involved light chain measures ≥ 10 mg/dL and with an abnormal ratio
- Estimated life expectancy ≥ 3 months
- 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
- Participants who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose within 4 weeks before agenT-797
- Prior radiotherapy within 2 weeks of start of study treatment
- Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks prior to dose of study drug
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45267
Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida
Louisville, Kentucky, 40207
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) in Subjects With Relapsed/Refractory Multiple Myeloma
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 or refractory multiple myeloma, as well as to define the recommended Phase 2 dose.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- agenT-797
- Keywords
- Multiple myeloma, Immunotherapy, iNKT cells
- Medical subject headings
- Multiple Myeloma
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.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic iNKT Cells | Experimental | 3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days [2 weeks]). Receives: Drug: agenT-797 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants With Treatment-related Adverse Events
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Measured: Baseline through Day 28 post cell infusion
Number Of Dose-limiting Toxicities
Measured: Baseline through Day 14 post cell infusion
Secondary outcomes (6)
Persistence Of agenT-797 In Peripheral Blood
Measured: Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0,5, 1, 2, and 4 hours post cell infusion), Days 2, 3, 5, 8, 15, 22, and 29, Weeks 6, 8, and 12, and Months 6, 9, and 12
Overall Response Rate (ORR)
Measured: End of study visit (up to 12 months)
Duration Of Response (DOR)
Measured: End of study visit (up to 12 months)
Duration Of Clinical Benefit
Measured: End of study visit (up to 12 months)
Time To Response (TTR)
Measured: End of study visit (up to 12 months)
Measurement Of Serum Alloantibodies To Major Histocompatibility Complex Class I And II
Measured: Baseline/Day 1 (pre-infusion), Day 22, Week 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.
- First posted15 Feb 2021
- Study start29 Mar 2021
- Primary completion13 Jan 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiNK Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, MiNK Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754100
- Sponsor's protocol ID
- 2019-1305
- Status last verified
- Jun 2023
- First submitted
- 3 Feb 2021
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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) in Subjects With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04754100
- Acronym / sponsor ID
- 2019-1305
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Keywords
- Multiple myeloma, Immunotherapy, iNKT cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- MiNK TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 or refractory multiple myeloma, as well as to define the recommended Phase 2 dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic iNKT Cells | Experimental | Drug: agenT-7973+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days [2 weeks]). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Relapsed/Refractory Multiple Myeloma
- Estimated life expectancy ≥ 3 months
- 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
Key exclusion criteria (4 listed)
- Concurrent invasive malignancy
- Participants who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose within 4 weeks before agenT-797
- Prior radiotherapy within 2 weeks of start of study treatment
- Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks prior to dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| agenT-797agenT-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 | Allogeneic iNKT Cells |
Primary outcome
Number Of Participants With Treatment-related Adverse Events
Time frame: Baseline through Day 28 post cell infusion
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Number Of Dose-limiting Toxicities
Time frame: Baseline through Day 14 post cell infusion
6 secondary outcomes
Persistence Of agenT-797 In Peripheral Blood
Time frame: Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0,5, 1, 2, and 4 hours post cell infusion), Days 2, 3, 5, 8, 15, 22, and 29, Weeks 6, 8, and 12, and Months 6, 9, and 12
Overall Response Rate (ORR)
Time frame: End of study visit (up to 12 months)
Duration Of Response (DOR)
Time frame: End of study visit (up to 12 months)
Duration Of Clinical Benefit
Time frame: End of study visit (up to 12 months)
Time To Response (TTR)
Time frame: End of study visit (up to 12 months)
Measurement Of Serum Alloantibodies To Major Histocompatibility Complex Class I And II
Time frame: Baseline/Day 1 (pre-infusion), Day 22, Week 6, and end of study visit (up to 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
MiNK Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing agenT-797 in people with Relapsed/Refractory Multiple Myeloma, run by MiNK Therapeutics at 3 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 10 inclusion and 4 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 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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-related Adverse Events (time frame: Baseline through Day 28 post cell infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2023.