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Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Recruiting
I'm InterestedTrial ID: NCT04981119
Purpose
Objective:
To collect information on how often a solid tumor cancer might lose the Human Leukocyte
Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an
eligible participant's own T cells for future use to make CAR T-Cell therapy for their
disease treatment.
Design:
This is a non-interventional, observational study to evaluate participants with solid tumors
with a high risk of relapse for incurable disease. No interventional therapy will be
administered on this study. Some of the information regarding the participant's tumor
analysis may be beneficial to management of their disease. Participants that meet all
criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells
will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of
their cancer.
Official Title
An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing
Stanford Investigator(s)
Saurabh Dahiya, MD, FACP
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria
1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell
Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally
advanced, or in the Investigator's opinion the subject is high risk for incurable relapse
within two years.
Part 1: Key Exclusion Criteria
1. History of any of other malignancy in the past 5 years other than non-melanoma skin
carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal
carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
2. Prior allogeneic stem cell transplant.
3. Prior solid organ transplant.
Part 2 : Key Inclusion Criteria
1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell
Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC)
that is metastatic, unresectable locally advanced, or in the Investigator's opinion
the subject is high risk for incurable relapse within two years.
2. Participants are germline HLA-A*02 heterozygous confirmed by HLA typing.
3. Primary tumor tissue showing LOH of HLA-A*02 by NGS testing.
4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.
Part 2: Key Exclusion Criteria
1. History of any of other malignancy in the past 5 years other than non-melanoma skin
carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal
carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
2. Prior allogeneic stem cell transplant.
3. Prior solid organ transplant.
4. Participants who have received any cancer therapy on any investigational therapy for
any indication, including but not limited to chemotherapy, small molecules, monoclonal
antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned
apheresis or 3 half-lives, whichever is shorter.
5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) at study enrollment necessitating specific
treatment, or any major episode of infection requiring treatment with Intravenous (IV)
antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of
antibiotic course).
6. Has known active central nervous system metastases. Subjects with previously treated
brain metastases may participate upon medical monitor agreement.
7. In the Investigator's judgement, any other condition or reason the subject would not
complete the required study visits and procedures, and follow up visits, or comply
with the study requirements for participation.
Intervention(s):
other: Apheresis
diagnostic test: Next Generation Sequencing (NGS)
diagnostic test: Long Range NGS HLA typing
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Shruti Murthy