Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling
Status: | Recruiting |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2019 |
Start Date: | February 26, 2019 |
End Date: | December 2021 |
Contact: | Rebecca Griffith-Eskew |
Email: | griffith-eskew@immatics.com |
Phone: | 346-204-5359 |
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.
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.
The purpose of this screening study is to identify human leukocyte antigen (HLA) molecular
subtype positive and tumor antigen target(s) positive patients. No treatment intervention
will occur as part of this screening study.
After diagnosis of advanced and/or solid metastatic cancers, patients will be tested for HLA
molecular subtype positivity. Patients that are HLA molecular subtype positive are then
assessed to determine if their tumor antigen target(s) is positive (biopsy screening). Fresh
tumor tissue obtained by a biopsy for this screening study will be required. If the patient
is undergoing a surgical procedure directed towards tumor or palliative treatment (e.g., a
resection, debulking surgery, etc.) and has consented to the study, then fresh tissue may be
collected during the procedure to avoid the patient being subjected to another biopsy.
This screening biopsy is optional (as determined by the investigator) for patients with
uterine cancer (including endometrial cancer or uterine carcinosarcoma) and melanoma, if
other eligibility criteria are met.
Tumor antigen targets in fresh tumor samples will be determined by an in vitro diagnostic
(IVD) assay. Therefore, any remaining tumor specimens may be used for exploratory biomarker
analyses and validation studies for regulatory approval.
Immatics is conducting clinical studies which target patients with advanced and/or metastatic
solid cancers. Patients who are HLA subtype phenotype positive and whose tumors express one
or more of the tumor antigen targets of interest may be eligible for ongoing clinical studies
of adoptive cell therapy (ACT).
subtype positive and tumor antigen target(s) positive patients. No treatment intervention
will occur as part of this screening study.
After diagnosis of advanced and/or solid metastatic cancers, patients will be tested for HLA
molecular subtype positivity. Patients that are HLA molecular subtype positive are then
assessed to determine if their tumor antigen target(s) is positive (biopsy screening). Fresh
tumor tissue obtained by a biopsy for this screening study will be required. If the patient
is undergoing a surgical procedure directed towards tumor or palliative treatment (e.g., a
resection, debulking surgery, etc.) and has consented to the study, then fresh tissue may be
collected during the procedure to avoid the patient being subjected to another biopsy.
This screening biopsy is optional (as determined by the investigator) for patients with
uterine cancer (including endometrial cancer or uterine carcinosarcoma) and melanoma, if
other eligibility criteria are met.
Tumor antigen targets in fresh tumor samples will be determined by an in vitro diagnostic
(IVD) assay. Therefore, any remaining tumor specimens may be used for exploratory biomarker
analyses and validation studies for regulatory approval.
Immatics is conducting clinical studies which target patients with advanced and/or metastatic
solid cancers. Patients who are HLA subtype phenotype positive and whose tumors express one
or more of the tumor antigen targets of interest may be eligible for ongoing clinical studies
of adoptive cell therapy (ACT).
Inclusion Criteria:
1. Signed an Informed Consent Form (ICF)
2. Patients ≥ 18 years of age
3. Patients with confirmed advanced and/or metastatic solid tumors.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 0-1
6. Life expectancy > 6 months
7. There is no limitation for prior anti-cancer treatments
8. HLA molecular phenotype positive.
9. Measurable disease according to Response Evaluation Criteria in Solid Tumors
(RECIST)1.1
10. 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
11. Patient has adequate pulmonary function
12. Acceptable organ and marrow function
13. Acceptable coagulation status
14. Adequate hepatic function
15. Acceptable levels of serum creatinine
16. For liver cancer patients only, Child-Pugh score of < 6
Exclusion Criteria:
1. History of other malignancies (except for adequately treated basal or squamous cell
carcinoma or carcinoma in situ) within the last 3 years
2. Patients with primary central nervous system (CNS)/brain tumors
3. Patients whose tumors have very low expression of tumor antigen targets such as kidney
chromophobe, thyroid carcinoma, and prostate adenocarcinoma
4. Patients who are pregnant or are breastfeeding
5. 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
6. Patients with prior stem cell transplantation or solid organ transplantation
7. Any condition contraindicating leukapheresis
8. 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
9. Patients with active diverticulitis, intra-abdominal abscess, or GI obstruction
10. Patients with active pneumonitis
11. 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.
12. History of hypersensitivity on fludarabine (FLU), cyclophosphamide (CY), or
interleukin (IL)-2
13. History of current immunodeficiency disease or prior treatment compromising immune
function at the discretion of the investigator.
14. 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).
15. Patients with bleeding diathesis or coagulopathy
16. Any serious and/or unstable pre-existing medical, psychiatric disorder or other
conditions that could interfere with patient's safety
17. 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
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