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

An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study Design: Approximately 3000 participants will be screened for part 1 of the study, including HLA typing, approximately 1500 participants will have NGS testing on their tumor samples and be followed for up to 2 years on the study, and up to 500 participants will be screened for part 2 of the study and enrolled if eligible and apheresed and be followed for up to 2 years on the study."
  • "Participants will be screened (Part 1) for HLA type, and based on results, participants will have archived tumor tissue tested by next generation sequencing (NGS) and be followed for up to 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how often solid tumors lose an HLA gene, which helps the immune system recognize cells. It is for people whose cancer has spread, cannot be removed by surgery, or is likely to return within two years with no cure. The study gives no cancer treatment, but may collect and store T cells (immune cells) to make CAR T-cell therapy if the cancer returns.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both parts: Tests must confirm a solid tumor, such as colon, lung, or pancreatic cancer.
  • Both parts: Cancer must have spread, be advanced nearby and not removable by surgery, or be judged likely to return within two years with no cure.
  • Part 2: HLA testing must show you inherited one copy of HLA-A*02 and one different version of this gene.
  • Part 2: Gene testing must show that the original tumor lost HLA-A*02.
  • Part 2: You must be fully active or able to walk and do light work, with limits only on hard physical activity.

Who can't join

  • Both parts: Another cancer in the past five years. Exceptions include non-melanoma skin cancer, low-grade prostate cancer that has not spread, surface-only bladder cancer, breast or cervical cancer in place (not spread), or stage I uterine cancer.
  • Both parts: A past stem cell transplant from a donor.
  • Both parts: A past solid organ transplant.
  • Part 2: Recent cancer treatment or experimental treatment for any condition before planned blood cell collection. The wait is two weeks or three drug half-lives, whichever is shorter. A half-life is the time for the drug level to drop by half.
  • Part 2: An active infection needing treatment, except nail fungus, or a major infection needing medicines through a vein or a hospital stay.
  • Part 2: Active cancer spread to the brain or spinal cord. Previously treated brain spread may be allowed with the study medical monitor’s approval.
  • Part 2: Any other condition or reason the study doctor thinks would keep you from completing study visits, procedures, follow-up, or other requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (16)

AZ

CA

FL

MA

MN

MO

NY

OH

TN

TX

WA