Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing

Recruiting

I'm Interested

Trial 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
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 Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shruti Murthy

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