AGENT-797 in Patients With Relapsed/Refractory Multiple Myeloma

Study Purpose

This is a Phase I, open-label, dose-escalation, single arm study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in subjects with relapsed/refractory MM, as well as define the RP2D.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Written informed consent obtained prior to any screening procedures and in accordance with federal, local, and institutional guidelines.
  • - Age ≥ 18 years.
  • - Confirmed diagnosis, and evidence of progressive disease or clinical relapse as defined by International Myeloma Working Group (IMWG) criteria and following prior therapy for MM: 1.
Relapsed or refractory MM requiring current treatment. 2. Previously failed ≥ 3 prior regimens.
  • - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
  • - Estimated life expectancy ≥ 4 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.
  • - Female subjects of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at Screening, and male subjects must use an effective barrier method of contraception if sexually active with a female of childbearing potential.
  • - Subjects need a functioning, central venous access in place for the administration of agenT-797.

Exclusion Criteria:

  • - Pregnant or nursing women.
  • - Prior history of invasive malignancy.
  • - Subjects who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose.
  • - New York Heart Association Class III or IV heart failure, unstable angina, or a history of recent myocardial infarction.
  • - Adverse events from prior anticancer therapy that have not resolved to NCI CTCAE Grade ≤ 1.
  • - Receiving any investigational products within 4 weeks or 5 half-lives of cell infusion.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04754100
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AgenTus Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation AgenTus Therapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed/Refractory Multiple Myeloma
Additional Details

This is a Phase I, open-label, dose-escalation, single arm study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in subjects with relapsed/refractory MM, as well as define the RP2D. In Part 1, the study will employ a standard 3+3 dose escalation design, for which 3 to 6 evaluable subjects (maximally 9 if recommended by the Safety Review Committee [SRC]) will be enrolled at each assigned dose level, per cohort depending on the occurrence of DLTs. Part 2 will consist of one or more cohorts of in total up to around 6 to 12 subjects with relapsed/refractory MM who receive agenT-797 at a given dose after lymphodepletion and will employ a 3+3 dose escalation/de-escalation design depending on the occurrence of DLTs. The starting dose in Part 2 will be equal to the maximum tolerated dose (MTD) defined in Part 1 in the absence of any DLTs at that dose level. If a DLT is observed at the MTD in Part 1, the starting dose level in Part 2 will be the dose level below MTD. Details of the analyses will be described in a statistical analysis plan. A Safety Monitoring Committee will be established to assess safety and decide on escalation to next Cohort.

Arms & Interventions

Arms

Experimental: Dosage and Cohorts

Part 1: Dose escalation without lymphodepletion. Dosage Frequency and Mode of Administration: agenT-797 will be administered to subjects as a single IV infusion. Part 2: Dose escalation with lymphodepletion (optional) Dosage Frequency and Mode of Administration: Subjects will receive lymphodepletion before infusion of agenT-797. Starting dose will be defined based on data from Part 1.

Interventions

Drug: - agenT-797

Part 1 agenT-797 is an off-the shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex-vivo. Part 2 agenT-797 is an off-the shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex-vivo. Lymphodepletion: The conditioning therapy will be administered prior to agenT-797 infusion. Dose and rate of infusion of the chemotherapy may be adapted as medically indicated.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Clifton Mo, MD

Clifton_Mo@DFCI.HARVARD.EDU

781-674-4265