18 Participants Needed

Adoptive T Cell Therapy for Melanoma

MN
AL
Overseen ByAnn Lau Clark, RN, MSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that patients taking steroids for disease control or pain management are excluded. It also requires a waiting period after certain treatments, like a 6-week gap after anti-CTLA-4 treatment and a 4-week gap after anti-PD-1 or anti-PD-L1 treatment.

Is adoptive T cell therapy for melanoma safe?

Initial studies show that genetically engineered T cells can cause tumor regression, but there are safety concerns like 'on-target, off-organ' toxicity, which means the treatment might affect healthy tissues. Efforts are being made to improve safety by carefully selecting target antigens and enhancing T cell receptor design.12345

What makes the treatment Autologous TIL 1383I TCR Gene Modified T Cells unique for melanoma?

This treatment is unique because it involves modifying a patient's own T cells to specifically target melanoma cells by introducing a gene for a T-cell receptor (TCR) that recognizes a melanoma-associated antigen. This approach aims to enhance the body's immune response against the cancer, offering a personalized and potentially more effective treatment option compared to traditional therapies.34678

What data supports the effectiveness of the treatment Autologous TIL 1383I TCR Gene Modified T Cells for melanoma?

Research shows that adoptive cell therapy using tumor-infiltrating lymphocytes (TILs) has led to significant responses in about 50% of patients with metastatic melanoma. Additionally, T cells modified with specific T-cell receptors (TCRs) have shown promise in targeting melanoma cells, suggesting potential effectiveness of this treatment.346910

Who Is on the Research Team?

MN

Michael Nishimura, PhD

Principal Investigator

Loyola University

Are You a Good Fit for This Trial?

Adults with advanced melanoma that can be measured, who are in good physical condition (ECOG PS of 0 or 1), and have tried certain treatments without success. They must not be pregnant, vulnerable individuals, or have severe infections or other health conditions that could interfere with the trial.

Inclusion Criteria

My melanoma has spread and can be measured by tests or seen on scans.
Patients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelines.
My heart and lungs are strong enough for IL-2 treatment.
See 8 more

Exclusion Criteria

I have not had active brain melanoma or treatment for it in the last 3 months.
Your blood test results show low levels of white blood cells or platelets, or high levels of certain liver or kidney markers.
Special classes of subjects such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of TIL 1383I TCR transduced T cells to determine the maximum tolerated dose

4 weeks
3 visits (in-person) for each cohort

Follow-up

Participants are monitored clinically and immunologically for safety and effectiveness after T cell infusion

1 year
Regular visits (in-person) over the year

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous TIL 1383I TCR Gene Modified T Cells
Trial Overview This Phase I trial is testing escalating doses of genetically modified T cells to treat advanced melanoma. It's funded by the NCI and aims to find the right dose for Phase II trials. Participants receive a retrovirus-modified version of their own T cells.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Escalating DosesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials
161
Recruited
31,400+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Adoptive cell transfer using tumor-infiltrating lymphocytes (TIL) has shown a significant response rate of about 50% in patients with metastatic melanoma, indicating its potential as an effective treatment.
Genetically modifying T lymphocytes with T-cell receptors (TCR) targeting tumor antigens has demonstrated objective responses in melanoma, suggesting this approach could be expanded to treat other common epithelial cancers beyond melanoma.
[Application of gene therapy in tumor adoptive immunotherapy].Wang, C., Zhao, Y.[2012]
A specific T-cell receptor (TCR) targeting the melanoma antigen tyrosinase was successfully introduced into normal human T cells, enabling them to recognize and attack melanoma cells.
The engineered T cells not only secreted cytokines in response to melanoma cells but also demonstrated the ability to kill these cancer cells, highlighting the potential of this TCR for effective adoptive immunotherapy against melanoma.
Simultaneous generation of CD8+ and CD4+ melanoma-reactive T cells by retroviral-mediated transfer of a single T-cell receptor.Roszkowski, JJ., Lyons, GE., Kast, WM., et al.[2007]
T-cell receptor (TCR) gene-modified T cells can effectively cure mice with disseminated leukemia in a murine model of adoptive T-cell immunotherapy, showcasing the potential of this approach for treating human cancers.
To enhance the long-term effectiveness of TCR-modified T cells, activating these cells through their endogenous TCR can boost the expression of the introduced TCR, potentially leading to a stronger and more persistent antitumor response.
Adoptive immunotherapy of disseminated leukemia with TCR-transduced, CD8+ T cells expressing a known endogenous TCR.Dossett, ML., Teague, RM., Schmitt, TM., et al.[2021]

Citations

[Application of gene therapy in tumor adoptive immunotherapy]. [2012]
Simultaneous generation of CD8+ and CD4+ melanoma-reactive T cells by retroviral-mediated transfer of a single T-cell receptor. [2007]
Adoptive immunotherapy of disseminated leukemia with TCR-transduced, CD8+ T cells expressing a known endogenous TCR. [2021]
Adoptive Cell Therapy for Metastatic Melanoma. [2018]
MART-1 TCR gene-modified peripheral blood T cells for the treatment of metastatic melanoma: a phase I/IIa clinical trial. [2022]
Improving the efficacy and safety of engineered T cell therapy for cancer. [2020]
Genetic Modification of Tumor-Infiltrating Lymphocytes via Retroviral Transduction. [2021]
Selecting highly affine and well-expressed TCRs for gene therapy of melanoma. [2021]
Monoclonal T-cell receptors: new reagents for cancer therapy. [2022]
Exploiting the curative potential of adoptive T-cell therapy for cancer. [2023]
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