CD30 CAR for CD30+ NSGCT

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Nov 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults with Nonseminomatous Germ Cell Tumors (NSGCT), which are a type of cancer. The main goal of the trial is to gather samples from participants, like tumor tissue and blood, to see if modified immune cells called T cells are present in their bodies and how long they last. This research aims to improve future treatments for cancer patients by understanding how these modified cells can help fight tumors. The treatment being tested combines T cells with antibodies, both of which play important roles in the immune system's fight against cancer.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of NSGCT. They should have already received at least one prior treatment for their cancer and have evidence that the cancer is progressing. Participants can expect to provide some samples for research, and the study will monitor their health and response to the treatment. It's important to note that pregnant or breastfeeding individuals, as well as those with certain active infections, cannot participate in this study. This trial is currently recruiting participants who meet these criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.
• • 2. Age ≥ 18 years at the time of consent.
• • 3. Histologically confirmed diagnosis of Nonseminomatous Germ Cell Tumors (NSGCT) of any primary site.
• • 4. Subjects must have received at least one prior line of therapy for their NSGCT and meet one of the following criteria. There is no maximum number of prior lines of treatment allowed.
• • 5. Evidence of progressive or recurrent NSGCT after prior high-dose chemotherapy (HDCT) treatment, defined as meeting at least one of the following criteria: i. Tumor biopsy of new or growing or unresectable lesions demonstrating viable NSGCT. In the event of an incomplete gross resection where viable NSGCT is found, subjects will be considered eligible for the study. ii. Consecutive elevated serum tumor markers (β-HCG or AFP) are increasing. An increase of elevated lactate dehydrogenase (LDH) alone does not constitute progressive disease. iii. Development of new or enlarging lesions in the setting of persistently elevated β-HCG or AFP, even if the β-HCG and AFP are not continuing to rise.
• Exclusion Criteria:
• • 1. Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated in the study).
• • 2. Active infection with HIV, human T-cell leukemia virus, hepatitis B virus, and hepatitis C virus (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells). Note: To meet eligibility subjects are required to be negative for HIV antibody, negative for HTLV1 and 2 antibodies or PCR negative for HTLV1 and 2, negative for Hepatitis B surface antigen, and negative for HCV antibody or HCV viral load.