ACTengine® IMA203 Combined With mRNA-4203

Study Purpose

This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203. The trial includes participants with previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).

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:

- Pathologically confirmed and documented cutaneous melanoma (CM) or synovial sarcoma (SS) with unresectable or metastatic disease.

- HLA-A*02:01 positive.

- Adequate selected organ function per protocol.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) - Life expectancy more than 5 months.

- CM participants who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor.

- SS participants must have received (or declined) at least one line of treatment (including SoC) and are still in need of further systemic therapy.

- Female participants of childbearing potential must use adequate contraception prior to trial entry until 12 months after the infusion of IMA203 and 15 days after the last mRNA 4203 dose administration.

Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years.

- Pregnant or breastfeeding.

- Serious autoimmune disease.

- History of cardiac conditions as per protocol.

- Prior allogenic stem cell transplantation or solid organ transplantation.

- Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study.

- History of hypersensitivity to cyclophosphamide, fludarabine, or IL-2.

- History of hypersensitivity to mRNA-based medicines.

- Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.

- Any condition contraindicating leukapheresis.

- Participants with lactate dehydrogenase (LDH) greater than threshold allowed per protocol.

- Participants with active brain metastases prior to lymphodepletion.

- Concurrent treatment in another clinical trial or a device trial that could interfere with the IMA203 treatment.

- Participants with renal impairment AND reduced bone marrow reserve per protocol.

Other protocol defined exclusion criteria could apply

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.	NCT06946225
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.	Immatics US, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cutaneous Melanoma, Synovial Sarcoma

Additional Details

This clinical trial is a multi-center, open-label, non-comparative Phase 1 a/b trial to assess the safety, tolerability, and anti-tumor activity of the combination of IMA203 and mRNA-4203 in HLA-A*02:01 positive patients with previously treated, unresectable or metastatic cutaneous melanoma (CM) and synovial sarcoma (SS).

Arms & Interventions

Arms

Experimental: IMA203 with mRNA-4203 in participants with metastatic cutaneous melanoma or synovial sarcoma

This is a non-comparative, open-label trial with different cohorts investigating IMA203 in combination with mRNA-4203.

Interventions

Biological: - IMA203

Following non-myeloablative chemotherapy for lymphodepletion (LD) with fludarabine (FLU) and cyclophosphamide (CY), participants will receive a single infusion of IMA203 on Day 1 and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion.

Biological: - mRNA-4203

mRNA-4203 will be administered starting on Day 15 after IMA203 infusion at the earliest. mRNA-4203 will be given for 12 cycles (28 day cycle length); during Cycle 1 it will be given on Day 1 and Day 15 and in Cycles 2-12 it will be given on Day 1.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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