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IMA201 Product

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |Immatics N.V.|Last Updated: Feb 4, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

IMA201 Product · 1 trial · 4 indications

Phase 1 1
NCT03247309TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)Solid Tumor
COMPLETED7 Analytics
PHASE1COMPLETED
TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AE)
up to 3 years post-treatment
Determination of the maximum tolerated dose (MTD)
until 21 days post treatment

Secondary Endpoints

Duration of infused T cells over time (Persistence of T cells)
up to 3 years post-treatment
Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)
up to 12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IMA201 ProductEXPERIMENTAL* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * One dose of IMA201 product will be infused intravenously. Up to four dose levels will be evaluated. At least two patients per cohort will be treated. * Post-infusion of IMA201 product, administration of low-dose recombinant human interleukin-2

Interventions

NameTypeDescription
IMA201 ProductBIOLOGICALThe cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
IMADetect®DIAGNOSTIC_TESTIMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in clinical trials with investigational IMA201 therapy. IMADetect® is intended for investigational use only.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patient ≥ 18 years of age * Pathologically confirmed advanced and/or metastatic solid tumor * Patients may enter screening procedure before, during, or after the last available indicated standard of care treatment. There is no limitation for prior anti cancer treatments. * Eas...

Countries:United StatesGermany
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about IMA201 Product

What is IMA201 Product used for?

IMA201 Product is an investigational monoclonal antibody being developed for the treatment of solid tumors, including recurrent and refractory solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes IMA201 Product?

IMA201 Product is being developed by Immatics N.V., a biopharmaceutical company traded on the stock exchange under the ticker symbol IMTX. The company is conducting clinical research on this investigational therapy for solid tumors.

What phase is IMA201 Product in?

IMA201 Product is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The Phase 1 trial has been completed, and the drug remains under investigation for the treatment of solid tumors.

What clinical trials is IMA201 Product in?

IMA201 Product has been studied in one clinical trial with the identifier NCT03247309, titled "TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)." This Phase 1 trial enrolled 7 participants and was conducted in the United States and Germany.

Is IMA201 Product the same as ACTengine IMA201-101?

IMA201 Product is associated with the clinical trial ACTengine IMA201-101, which is the study name for the Phase 1 trial of this investigational therapy. The trial evaluated the product in patients with solid tumors, including recurrent and refractory cases.