Using modified T cells to treat Nonseminomatous Germ Cell Tumors
Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Patients With CD30+ Nonseminomatous Germ Cell Tumors (NSGCT)
This study is testing if modified T cells can help treat adults with Nonseminomatous Germ Cell Tumors and looking at how long these cells stay in the body.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, chimeric antigen receptor |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05634785 on ClinicalTrials.gov |
What this trial studies
This phase 2 research focuses on adult patients with Nonseminomatous Germ Cell Tumors (NSGCT) to investigate the presence of modified T cells in their plasma or tumors. The study involves collecting biospecimens such as tumor tissue and blood to create a biobank for future research. Researchers aim to understand how long these modified T cells persist in the body and their potential role in improving treatment options for cancer patients. The study also evaluates the effectiveness of the ATLCAR.CD30 cellular therapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of Nonseminomatous Germ Cell Tumors who have received at least one prior line of therapy.
Not a fit: Patients who have not been diagnosed with Nonseminomatous Germ Cell Tumors or those who have not received prior treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with Nonseminomatous Germ Cell Tumors.
How similar studies have performed: Other studies utilizing modified T cell therapies have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chapel Hill, North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Matthew I Milowsky — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Catherine Cheng
- Email: UNCImmunotherapy@med.unc.edu
- Phone: 919-445-4208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.