ACTengine® IMA203 Combined With mRNA-4203
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmatics US, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
IMA203
Biological/VaccineFollowing 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.
mRNA-4203
Biological/VaccinemRNA-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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: IMA203 with mRNA-4203 in participants with metastatic cutaneous melanoma or synovial sarcomaExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with dose-limiting toxicities (DLTs)
Number of DLTs will be used to determine the maximum tolerated dose (MTD) and/or recommended dose for extension (RDE) after treatment with IMA203 product in combination with mRNA-4203
Time frame
one year post infusion of IMA2032
Number of treatment emergent adverse events (AEs), AEs of special interest, serious AEs (SAEs), changes in laboratory parameters and vital signs, and frequency of dose interruptions, reductions and discontinuations
Used to evaluate safety and tolerability of treatment with IMA203 in combination with mRNA-4203
Time frame
one year post infusion of IMA203Secondary outcomes
1
Objective response rate (ORR)
complete response (CR) and partial response (PR) based on best overall response (BOR), locally assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame
one year post infusion of IMA2032
Duration of response (DOR)
CR and PR, locally assessed using RECIST v1.1
Time frame
one year post infusion of IMA2033
Disease control rate (DCR)
CR, PR and stable disease (SD) lasting 6 or more weeks following the infusion of IMA203, locally assessed using RECIST v1.1
Time frame
one year post infusion of IMA2034
Progression-free survival (PFS)
locally assessed using RECIST v1.1
Time frame
one year post infusion of IMA203Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Immatics US, Inc.
Lead sponsor
ModernaTX, Inc.
Collaborator
Source ClinicalTrials.gov