Status:
COMPLETED
TCR-engineered T Cells in Solid Tumors: IMA202-101
Lead Sponsor:
Immatics US, Inc.
Conditions:
Solid Tumor, Adult
Refractory Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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).
Detailed Description
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 le...
Eligibility Criteria
Inclusion
- 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
- Measurable disease and accessible to biopsy
- Adequate pulmonary function per protocol
- Acceptable 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 IMA202 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
- IMA202 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 IMA202
- Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA202
- Hepatocellular carcinoma (HCC) patients with liver cirrhosis only - upper endoscopy is required within 6 months of study entry
- 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), 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
- 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 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.
- 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 :
May 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03441100
Start Date
May 2 2019
End Date
March 17 2023
Last Update
February 4 2025
Active Locations (6)
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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 Würzburg
Würzburg, Bavaria, Germany, 97080
4
Universitätsklinikum Bonn - Medizinische Klinik III
Bonn, North Rhine-Westphalia, Germany, 53127