70 Participants Needed

AIC100 CAR T Cells for Thyroid Cancer

Recruiting at 3 trial locations
AT
JG
DB
SG
Overseen BySonal Gupta, MD PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AffyImmune Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using modified immune cells to fight certain types of thyroid cancer that haven't responded to other treatments. The patient's own cells are changed in a lab to better target and kill cancer cells, then reintroduced into their body. This new method aims to improve the ability of the patient's immune system to find and destroy cancer cells.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, there is a requirement to meet the minimum washout time for previous cancer treatments before certain procedures, so it's best to discuss your specific medications with the study team.

What safety data exists for AIC100 CAR T Cells in humans?

CAR T cell therapy, including treatments like AIC100, can have side effects such as thyroid inflammation (thyroiditis), as seen in some patients with other conditions. However, reports of severe immune-related reactions are rare, and more research is needed to fully understand the safety profile.12345

How is the AIC100 CAR T Cells treatment different from other treatments for thyroid cancer?

AIC100 CAR T Cells treatment is unique because it uses genetically modified immune cells (CAR T cells) to specifically target and kill thyroid cancer cells that express a protein called ICAM-1, which is often found in aggressive thyroid cancers. This approach is different from traditional treatments as it offers a targeted and potentially more effective option for cancers with limited treatment choices.26789

What data supports the effectiveness of the AIC100 CAR T Cells treatment for thyroid cancer?

Research shows that CAR T cells targeting ICAM-1 can effectively kill thyroid cancer cells in lab studies and animal models, leading to long-term remission and improved survival in mice with advanced thyroid cancer.2671011

Who Is on the Research Team?

SG

Sonal Gupta, MD PhD

Principal Investigator

AffyImmune Therapeutics, Inc.

Are You a Good Fit for This Trial?

Adults over 18 with relapsed/refractory poorly differentiated thyroid cancer or anaplastic thyroid cancer, who have measurable disease and are in relatively good health. Participants must not be pregnant, breastfeeding, or on certain immunosuppressants. They should not have had gene therapy before and must agree to use effective contraception.

Inclusion Criteria

My liver, kidneys, heart, blood, and bone marrow are all working well.
Women who could become pregnant must have a negative pregnancy test.
My thyroid cancer tests positive for ICAM-1.
See 6 more

Exclusion Criteria

I am not allergic to chemotherapy drugs or any components of AIC100 CAR T Cells.
I do not have severe chronic diseases like kidney, liver, heart, or lung conditions.
I have not had gene or CAR T cell therapy before.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Apheresis and CAR T Cell Preparation

Patients undergo apheresis for collection of autologous lymphocytes, which are then transfected and expanded in vitro to generate the AIC100 CAR T Cell product

3-4 weeks

Lymphodepleting Chemotherapy

Patients receive lymphodepleting chemotherapy prior to CAR T cell infusion

1 week

Treatment

Infusion of AIC100 CAR T Cells at various dose levels

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for adverse events and persistence of CAR T cells

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

  • AIC100 CAR T Cells
Trial Overview The trial is testing AIC100 CAR T Cells for safety and tolerability to find the best dose for Phase 2 trials in patients with specific types of advanced thyroid cancer that haven't responded well to other treatments.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment1 Intervention
Group II: Cohort 4Experimental Treatment1 Intervention
Group III: Cohort 3Experimental Treatment1 Intervention
Group IV: Cohort 2.5Experimental Treatment1 Intervention
Group V: Cohort 2Experimental Treatment1 Intervention
Group VI: Cohort 1Experimental Treatment1 Intervention
Group VII: Cohort -1Experimental Treatment1 Intervention

AIC100 CAR T Cells is already approved in United States for the following indications:

🇺🇸
Approved in United States as AIC100 CAR T Cells for:

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Who Is Running the Clinical Trial?

AffyImmune Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
70+

Published Research Related to This Trial

In a study of 505 thyroid cancer samples, researchers identified three immune cell infiltration (ICI) subtypes, revealing that a higher ICI score is linked to increased tumor mutation burden and better overall survival rates.
Patients with high ICI scores showed significant therapeutic benefits from immunotherapy, suggesting that ICI scores can serve as a valuable prognostic indicator for treatment response in thyroid cancer.
Characterization of the Immune Cell Infiltration Landscape of Thyroid Cancer for Improved Immunotherapy.Gong, J., Jin, B., Shang, L., et al.[2021]
In a study of 46 intermediate-risk differentiated thyroid cancer patients, BRAF mutations and high AXL expression were linked to a poorer response to radioiodine therapy (RIT), suggesting these factors could help identify patients who may not benefit as much from RIT.
The research also found that higher levels of PD-L1 and lower levels of NIS expression were associated with less effective RIT responses, indicating that these biomarkers could be used to tailor treatment strategies for better outcomes.
BRAF-AXL-PD-L1 Signaling Axis as a Possible Biological Marker for RAI Treatment in the Thyroid Cancer ATA Intermediate Risk Category.Pizzimenti, C., Fiorentino, V., Ieni, A., et al.[2023]
Thyroid cancer is the most common endocrine tumor, with 33,550 new cases diagnosed annually and a relatively low mortality rate of 1,530 patients per year, indicating a generally favorable prognosis.
Recent advancements in treatment options for thyroid carcinoma have shown unexpectedly positive results, suggesting that new therapeutic agents may improve patient outcomes compared to traditional methods.
Old and new insights in the treatment of thyroid carcinoma.Gasent Blesa, JM., Grande Pulido, E., Provencio Pulla, M., et al.[2021]

Citations

Characterization of the Immune Cell Infiltration Landscape of Thyroid Cancer for Improved Immunotherapy. [2021]
BRAF-AXL-PD-L1 Signaling Axis as a Possible Biological Marker for RAI Treatment in the Thyroid Cancer ATA Intermediate Risk Category. [2023]
Old and new insights in the treatment of thyroid carcinoma. [2021]
Advances in cellular therapy for the treatment of thyroid cancer. [2022]
CAR T Therapy Targeting ICAM-1 Eliminates Advanced Human Thyroid Tumors. [2019]
Reduced Tumor Size of Untreated Papillary Thyroid Carcinoma After Immune Checkpoint Inhibitor-Induced Thyroiditis. [2023]
Case report: Hashimoto's thyroiditis after CD19 chimeric antigen receptor T-cell therapy. [2022]
Thyroid Immune-Related Adverse Events in Patients with Cancer Treated with anti-PD1/anti-CTLA4 Immune Checkpoint Inhibitor Combination: Clinical Course and Outcomes. [2022]
Current and future immunotherapies for thyroid cancer. [2018]
Thyroid tumor-initiating cells: increasing evidence and opportunities for anticancer therapy (review). [2021]
Targeting the BRAF Signaling Pathway in CD133pos Cancer Stem Cells of Anaplastic Thyroid Carcinoma [2019]
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