Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling

Completed

Conditions studied: Refractory Cancer, Recurrent Cancer, Adult Solid Tumor, Neoplasms

In brief

This screening study will identify HLA molecular subtype positive and tumor antigen target(s) positive patients who may be eligible for enrollment into Immatics clinical studies. This screening study is intended for patients with advanced and/or metastatic solid cancers. No treatment intervention will occur as part of this screening study.

Key facts

Study ID

NCT03760952

Run by

Immatics US, Inc.

People needed

242

Starts

2019-02-26

Expected to finish

2022-11-15

Last updated by the study team

2025-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed an Informed Consent Form (ICF)
• Patients ≥ 18 years of age
• Patients with confirmed advanced and/or metastatic solid tumors.
• For liver cancer patients, the diagnosis must be confirmed
• Pathological diagnosis of liver cancer based on biopsy/resection is required
• For patients without pathological diagnosis, an imaging technique obtained by computed tomography (CT) scan or magnetic resonance imaging (MRI) is needed.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 0-1
• Life expectancy > 6 months
• There is no limitation for prior anti-cancer treatments
• HLA molecular phenotype positive.
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)1.1
• At least one lesion considered accessible for biopsy unless fresh tumor tissue is being collected during a surgical procedure directed towards tumor treatment or palliative therapy or the patient has uterine cancer (including endometrial cancer or uterine carcinosarcoma) or melanoma
• Patient has adequate pulmonary function
• Acceptable organ and marrow function
• Acceptable coagulation status
• Adequate hepatic function
• Acceptable levels of serum creatinine
• For liver cancer patients only, Child-Pugh score of < 6

You may not qualify if…

• History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
• Patients with primary central nervous system (CNS)/brain tumors
• Patients whose tumors have very low expression of tumor antigen targets such as kidney chromophobe, thyroid carcinoma, and prostate adenocarcinoma
• Patients who are pregnant or are breastfeeding
• Patients with 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
• Patients with prior stem cell transplantation or solid organ transplantation
• Any condition contraindicating leukapheresis
• Patients with any of the following cardiac conditions: uncontrolled hypertension despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure, baseline left ventricular ejection fraction ≤ 50%, prior or current cardiomyopathy, atrial fibrillation with heart rate > 100 bpm, unstable ischemic heart disease
• Patients with active diverticulitis, intra-abdominal abscess, or GI obstruction
• Patients with active pneumonitis
• Patients with active (uncontrolled/untreated) 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.
• History of hypersensitivity on fludarabine (FLU), cyclophosphamide (CY), or interleukin (IL)-2
• History of current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator.
• Patients with Grade 3 or Grade 4 immune-related toxicities related to checkpoint inhibitors or patients requiring corticosteroid treatment (≥ 10 mg/day prednisone or equivalent dose).
• Patients with bleeding diathesis or coagulopathy
• Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with patient's safety
• HIV infection, active hepatitis B or C infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and/or nucleic acid testing

Where it is running

• University of Chicago — Chicago, Illinois, United States
• Columbia University Medical Center — New York, New York, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Oncology Consultants — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.