Activated T Cells for Brain Cancer

Overseen By Clinical Trial Navigator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jeremy Rudnick, M.D

Disqualifiers: Pulmonary, Cardiac, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment where a patient's own immune cells are enhanced to better fight cancer. It aims to find out if this treatment is safe and how well it works for cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Activated Autologous T Cells for brain cancer?

Research shows that using activated T cells, which are a type of immune cell, can help fight brain tumors. In some studies, patients with brain cancer who received this treatment had their tumors shrink, and a few remained disease-free for years. This suggests that the treatment might be effective, but more studies are needed to confirm its benefits. ^{1 2 3 4 5}

Is the treatment with activated T cells generally safe for humans?

Studies on activated T cells for brain cancer have shown that the treatment is generally safe, with most patients experiencing only mild side effects like flu-like symptoms. These studies suggest that the therapy is feasible and associated with minimal toxicity, although more research is needed to fully understand its safety. ^{1 2 6 7 8}

How does the treatment Activated Autologous T Cells differ from other treatments for brain cancer?

Activated Autologous T Cells are unique because they involve using a patient's own immune cells, which are collected, activated, and then reinfused to specifically target and attack brain tumor cells. This personalized approach contrasts with traditional treatments like chemotherapy and radiation, which are less targeted and can affect healthy cells as well. ^{1 2 9 10 11}

Research Team

Jeremy D. Rudnick

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for individuals with recurrent glioblastoma who are HLA-A1 and HLA-A2 positive and have had a complete resection of their tumor. It's not suitable for those with HIV/AIDS, hepatitis B or C, allergies to DMSO or gentamicin, significant heart or lung disease, or active infections needing treatment.

Inclusion Criteria

My brain cancer has come back after treatment.

I am HLA-A1 and HLA-A2 positive.

My tumor has been completely removed surgically.

Exclusion Criteria

I am not currently being treated for an infection, but I may be taking preventive medication.

I have a history of Hepatitis B or C.

Allergy to Dimethyl sulfoxide (DMSO)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive activated autologous T cells to assess safety and tolerability

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 2

Long-term follow-up

Participants are assessed for overall response rate and tumor stem cell antigen expression

Up to 3 years

Treatment Details

Interventions

• Activated Autologous T Cells

Trial Overview The study tests the safety and tolerability of autologous activated T cells (ATCs) in patients with recurrent glioblastoma. It aims to find the maximum tolerated dose while monitoring serious adverse events and treatment-related toxicities using NCI CTCAE V5 criteria.

Participant Groups

Group I: Activated T cells Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Jeremy Rudnick, M.D

Lead Sponsor

Trials

1

Recruited

10+

Kairos Pharma

Collaborator

Trials

1

Recruited

10+

Findings from Research

In a study involving 15 patients with recurrent astrocytoma, researchers successfully generated and expanded tumor-specific T cells from patients' blood after immunization with their own tumor cells, demonstrating the feasibility of this approach.

The intravenous transfer of these stimulated T cells was well-tolerated with limited toxicity, paving the way for future controlled studies to evaluate the anti-tumor effects of this immunotherapy strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous tumor cell vaccination combined with adoptive cellular immunotherapy in patients with grade III/IV astrocytoma. Holladay, FP., Heitz-Turner, T., Bayer, WL., et al.[2019]

Adoptive transfer of ex vivo activated T lymphocytes from tumor-draining lymph nodes has shown effectiveness in treating experimental brain tumors, requiring both CD4 and CD8 T cells for optimal tumor regression.

A phase I clinical trial is underway to evaluate this T cell therapy for malignant astrocytomas, highlighting its potential as a targeted immunotherapy for brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoptive immunotherapy of intracranial tumors by systemic transfer of tumor-draining lymph node cells (Review). Plautz, G., Shu, S.[2019]

Malignant central nervous system tumors are the leading cause of cancer death in children, and while treatments like surgery and chemotherapy can be effective, they often lead to significant neurological and cognitive side effects.

Adoptive cell therapy using CAR T cells shows promise for treating pediatric brain tumors, but challenges such as tumor heterogeneity and the blood-brain barrier limit its effectiveness; recent preclinical studies are exploring ways to enhance the safety and efficacy of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAR T Cell Therapy's Potential for Pediatric Brain Tumors. Thomas, P., Galopin, N., Bonérandi, E., et al.[2021]

Engineered T cell therapies, like CAR T cells and TCR T cell therapies, have shown remarkable efficacy in treating certain blood cancers, highlighting their potential as a powerful tool in cancer immunotherapy.

However, these therapies also pose unique safety challenges, such as cytokine release syndrome and neurotoxicity, which require careful nonclinical safety assessments to ensure patient safety during development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonclinical safety assessment of engineered T cell therapies. Lebrec, H., Maier, CC., Maki, K., et al.[2022]

Cellular vaccines for gliomas, including those using engineered T cells and autologous dendritic cells, have shown safety and feasibility in clinical trials, indicating they could be a promising approach for treating aggressive brain tumors like glioblastomas.

While these therapies have demonstrated some immune response activation, their overall therapeutic effects have been limited, highlighting the need for larger studies and improved guidelines to enhance their effectiveness in glioma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implication of cellular vaccine in glioma: current advances and future prospects. Yan, Y., Zeng, S., Gong, Z., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Autologous tumor cell vaccination combined with adoptive cellular immunotherapy in patients with grade III/IV astrocytoma. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A pilot study of autologous cancer cell vaccination and cellular immunotherapy using anti-CD3 stimulated lymphocytes in patients with recurrent grade III/IV astrocytoma. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Preliminary clinical trial of immunotherapy for malignant glioma. [2007]

4. Greece pubmed.ncbi.nlm.nih.gov

Systemic Intravenous Adoptive Transfer of Autologous Lymphokine-activated αβ T-Cells Improves Temozolomide-induced Lymphopenia in Patients with Glioma. [2018]

5. Greece pubmed.ncbi.nlm.nih.gov

Adoptive immunotherapy of intracranial tumors by systemic transfer of tumor-draining lymph node cells (Review). [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

CAR T Cell Therapy's Potential for Pediatric Brain Tumors. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Nonclinical safety assessment of engineered T cell therapies. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Clinical implication of cellular vaccine in glioma: current advances and future prospects. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Induction of human autologous cytotoxic T lymphocytes against minced tissues of glioblastoma multiforme. [2008]

10. United States pubmed.ncbi.nlm.nih.gov

The human leukemic T-cell line, TALL-104, is cytotoxic to human malignant brain tumors and traffics through brain tissue: implications for local adoptive immunotherapy. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Establishment of interleukin 2 dependent cytotoxic T lymphocyte cell line specific for autologous brain tumor and its intracranial administration for therapy of the tumor. [2019]