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New treatment option for Cutaneous Melanoma
Official title ACTengine® IMA203 Combined With mRNA-4203
ClinicalTrials.gov ID: NCT06946225
What this study is testing
What is IMA203?
IMA203 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cutaneous melanoma.
Also referred to as anzutresgene autoleucel, anzu-cel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Boston, Massachusetts, United States; New York, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.