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The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1).
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and a biopsy for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA202 product.
MANUFACTURING: IMA202 product will be made from the patient's white blood cells.
TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA202 product infusion to improve the duration of time that IMA202 product stays in the body. The patient will be admitted to the hospital during the treatment.
After the IMA202 product infusion, a low dose of IL-2 will be given twice daily for a period of time.
Patients will be closely monitored for safety and for a total of 3 years post IMA202 infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: IMA202 Product | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMA202 Product | Drug | The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AE) | up to 3 years post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
Solid tumors with low likelihood of tumor biomarker expression per protocol
Pregnant or breastfeeding
Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
History of cardiac conditions as per protocol
Prior 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 (CY), fludarabine (FLU), IL-2, or any of the rescue medications
History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
HIV infection, active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, ongoing active anti-HCV treatment or detectable HBV or HCV viral load at the most recent laboratory report. Patients with both HBV and HCV infections will be excluded from screening
Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA202 treatment
Patients with any active viral infection
Patients with active brain metastases
NOTE: Patients with a history of brain metastases may be eligible, if an imaging scan with contrast enhancement not older than 4 weeks is able to exclude the existence of currently active brain metastasis, and steroid therapy has been discontinued for ≥2 weeks.
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| Name | Affiliation | Role |
|---|---|---|
| Cedrik Britten, MD | Immatics US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States | ||
| University of Texas MD Anderson Cancer Center |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| IMADetect® | Device | IMADetect® 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. IMADetect® is intended for investigational use only. |
|
| Houston |
| Texas |
| 77030 |
| United States |
| Universitätsklinikum Würzburg | Würzburg | Bavaria | 97080 | Germany |
| Universitätsklinikum Bonn - Medizinische Klinik III | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Universitätsklinikum C.-G.-Carus Dresden | Dresden | Saxony | 01307 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |