Status:
COMPLETED
TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)
Lead Sponsor:
Immatics US, Inc.
Conditions:
Solid Tumor
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).
Detailed Description
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and the biomarkers screening. If the patient is eligible, white blood cells will be taken during leukaphere...
Eligibility Criteria
Inclusion
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- HLA phenotype positive for the study
- Patients must have measurable disease according to RECIST 1.1
- Disease accessible to biopsy
- Adequate pulmonary function per protocol
- Adequate organ and bone marrow function per protocol
- Acceptable coagulation status per protocol
- Adequate hepatic function per protocol
- Adequate renal function per protocol
- Patient's tumor must express tumor antigen by qPCR using a fresh tumor biopsy specimen
- Life expectancy more than 3 months
- Confirmed availability of production capacities for IMA201 product
- Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.
- For hepatocellular carcinoma (HCC) patients only, Child-Pugh score of ≤ 6
- IMA201 product must have passed all of the release tests
- Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA201
- Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA201
- The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to lymphodepletion. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities if these toxicities are not anticipated to further improve (e.g., chronic neuropathy) and such toxicities are not anticipated to worsen with the lymphodepletion therapy
Exclusion
- 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), or IL-2, or to 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
- Patients with a history of HCV infection and with an undetectable viral load per the most recent laboratory report and/or completed anti-HCV treatment but are HCV antibody positive are permitted.
- History of treated HBV infection is permitted if the viral load is undetectable per the most recent laboratory report. Note: HCC patients with controlled HBV infection, as defined by resolved (anti-hepatitis B surface antigen \[HBs-Ag\] antibody (Ab) negative, anti-core antigen \[HBc Ag\] Ab positive) or chronic stable (anti HBs-Ag Ab positive) HBV infection will be eligible for screening. Patients with active HBV infection who are not on anti-HBV treatment will be excluded.
- Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA201 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.
- Treatment with protocol-defined excluded treatments, medical devices, and/or procedures per protocol
- Concurrent participation in an interventional part of another clinical trial
Key Trial Info
Start Date :
December 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03247309
Start Date
December 19 2018
End Date
September 18 2023
Last Update
February 4 2025
Active Locations (5)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Universitätsklinikum Bonn, Venusberg-Campus 1
Bonn, North Rhine-Westphalia, Germany, 53127
4
Universitätsklinikum Carl Gustav Carus, Fetscherstr. 74
Dresden, Saxony, Germany, 01307