CD8+ T Cells for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for brain cancer that has spread from melanoma, using special immune cells called CD8+ T cells to target the cancer. Participants receive these cells through an intrathecal infusion, which delivers them directly into the fluid around the brain and spinal cord. The study aims to test the safety and initial effects of this treatment, known as Intrathecal Cellular Adoptive Immunotherapy. Individuals with melanoma that has spread to the brain and who show certain genetic markers (HLA-A*0201+ or HLA-A*24 02+) might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that injecting immune cells directly into the spinal fluid is generally safe for patients with leptomeningeal disease from metastatic melanoma. A case report found that a patient tolerated this method well, suggesting its relative safety. No major reports have linked serious side effects directly to this treatment. However, as this is a Phase 1 trial, the primary goal is to assess the treatment's safety. Researchers are still gathering information to fully understand its safety profile.12345
Why do researchers think this study treatment might be promising for brain cancer?
Unlike the standard treatments for brain cancer, which often involve chemotherapy, radiation, or surgery, the intrathecal cellular adoptive immunotherapy being studied uses CD8+ T cells that are specifically engineered to target cancer cells. This approach is unique because it delivers these immune cells directly into the cerebrospinal fluid, allowing for a more targeted attack on the cancer cells in the brain and spinal cord. Researchers are excited about this treatment because it has the potential to offer a more precise and potentially effective way to combat leptomeningeal disease from metastatic melanoma, with fewer systemic side effects compared to traditional therapies.
What evidence suggests that this treatment might be an effective treatment for brain cancer?
This trial will investigate intrathecal cellular adoptive immunotherapy, specifically CD8+ T-cells, for treating melanoma patients with leptomeningeal disease (LMD). Studies have shown that delivering tumor-fighting immune cells directly into the spinal fluid can be safe and feasible for treating LMD. LMD is a serious condition where cancer spreads to the protective layers around the brain and spinal cord. Research indicates that this treatment, which uses a patient's own immune cells, has extended some patients' lives. In one study, 36% of patients lived a year or more, exceeding the usual survival time for this condition. This suggests that using immune cells to combat cancer in the brain and spinal area could offer new hope for patients facing this challenging situation.12678
Who Is on the Research Team?
Isabella Glitza, MD, PHD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intrathecal infusion of TAA-specific T cells on Cycle 1 Day 1 and Cycle 1 Day 15
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intrathecal Cellular Adoptive Immunotherapy
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The proposed study is a single arm Phase I trial aimed at treating up to 6 HLA-A\*0201+ and HLA-A\*24 02+ individuals with leptomeningeal disease from metastatic melanoma. On Cycle 1 Day 1 and Cycle 1 Day 15, patients will receive an intrathecal infusion of TAA-specific T cells. The patients will receive \~300 (150-300) million cells on Cycle 1 Day 1 and \~1000 (750-1000) million cells on Cycle 1Day 15.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
NCT07414979 | Phase 1 Study Of Intrathecal Cellular ...
Primary Objective: Evaluate the safety of adoptively transferred intrathecal ETC targeting melanoma tumors in patients with leptomeningeal ...
Intrathecal administration of tumor-infiltrating lymphocytes is ...
These results demonstrate the safety of intrathecal administration of TIL in melanoma patients with LMD and support the feasibility of conducting a prospective ...
3.
targetedonc.com
targetedonc.com/view/new-study-identifies-effective-treatments-for-melanoma-associated-leptomeningeal-diseaseNew Study Identifies Effective Treatments for Melanoma ...
In an interview, Vincent Law, of Moffitt Cancer Center, discussed a new study that offers hope for patients with melanoma brain metastasis.
Retrospective review of metastatic melanoma patients with ...
The results show increased survival measured in months or years, rather than weeks in a subgroup of patients, with 36% surviving a year or more. •. No such data ...
5.
onclive.com
onclive.com/view/the-challenge-treating-brain-metastases-and-leptomeningeal-disease-lmd-The Challenge Treating Brain Metastases and ...
Brain metastases present a significant challenge when managing patients with melanoma who progress after frontline therapy.
Grant Information
... Intrathecal Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells for Melanoma Patients with Leptomeningeal Disease.
Retrospective review of metastatic melanoma patients with ...
Outcomes of a retrospective cohort of patients with LMD that were treated with intrathecal interleukin-2 (IT IL-2) were reviewed to assess the long-term ...
Intrathecal cytotoxic T-cell immunotherapy for metastatic ...
A 49-year-old patient with primary, recurrent melanoma on the lower extremity developed metastatic leptomeningeal melanoma that did not respond to treatment.
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