What side effects are associated with this type of intervention?

Common treatments for thyroid cancer, particularly immunotherapies like CAR T cell therapy, can have significant side effects. CAR T cell therapy often leads to cytokine release syndrome (CRS), which can cause multiorgan dysfunction, including acute kidney injury and electrolyte abnormalities. Other side effects include serious infections, cytopenias, and neurotoxicity. Checkpoint inhibitor immunotherapy, another form of treatment, can cause rare kidney-related issues such as acute tubulointerstitial nephritis, immune complex glomerulonephritis, and thrombotic microangiopathy.

What prior FDA approvals exist?

The FDA has approved several treatments for thyroid cancer, including targeted therapies and immunotherapies. Notably, lenvatinib and sorafenib are kinase inhibitors approved for differentiated thyroid cancer, while vandetanib and cabozantinib are approved for medullary thyroid cancer. Although CAR T-cell therapy like AIC100 is still under investigation for thyroid cancer, immunotherapy approaches such as pembrolizumab, an anti-PD-1 antibody, have shown promise in treating various cancers, including thyroid cancer, by targeting cancer cells through the immune system.

What other types of research exist?

Promising alternatives to AIC100 CAR T cells for thyroid cancer patients include immune checkpoint inhibitors such as pembrolizumab (anti-PD-1) and nivolumab (anti-PD-1), which have shown efficacy in various cancers. Additionally, combination therapies involving immune checkpoint inhibitors and other agents, such as tyrosine kinase inhibitors (e.g., lenvatinib, sorafenib), are being explored and may offer novel treatment options in 2024.

← Back to Search

CAR T-cell Therapy

AIC100 CAR T Cells for Thyroid Cancer

Phase 1

Recruiting

Led By Koen van Besien, MD, PhD

Research Sponsored by AffyImmune Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have thyroid cancer that expresses ICAM-1 and meets specific diagnoses

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Must not have

Prior treatment with investigational gene therapy or CAR T cell therapy

Allergy to any of the chemotherapy drugs given during lymphodepletion or known hypersensitivity to any component of AIC100 CAR T Cells, including excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years post-infusion

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related responses, fatigue, changes in blood counts or chemistry. Specific side effects related to AIC100 CAR T Cells will be monitored closely due to their novel nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My thyroid cancer tests positive for ICAM-1.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am willing and able to join the study and can sign the consent form.

Select...

My cancer can be measured on scans.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had gene or CAR T cell therapy before.

Select...

I am not allergic to chemotherapy drugs or any components of AIC100 CAR T Cells.

Select...

I do not have severe chronic diseases like kidney, liver, heart, or lung conditions.

Select...

I have previously been treated with specific targeted cancer therapies.

Select...

I haven't taken immunosuppressants for my autoimmune disease in the last 4 weeks.

Select...

I am not pregnant or breastfeeding.

Select...

I have not had gene or genetically modified cell therapy.

Select...

I do not have any serious or uncontrolled infections.

Select...

I have an active brain or spinal cord disorder that affects my daily life.

Select...

I have not had any other cancer in the last 2 years.

Select...

I need to take more than 10 mg/day of prednisone or a similar medication for a long time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years post-infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine recommended phase 2 dose

Incidence of anticipated AIC100 CAR T Cell related AEs, SAEs and adverse events of special interest (AESI) (infusion-related reactions, CRS, ICANS, HLH/MAS, TLS, new malignancies, AEs leading to death and DLT AEs)

Incidence of overall Grade >=3 Adverse Events (AE) and Serious Adverse Events (SAE)

Secondary study objectives

Assessment of presence and frequency of AIC100 CAR T cells in peripheral blood and tumor samples (when available)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Cohort 5Experimental Treatment1 Intervention

AIC100 CAR T Cell Dose Level 5 (Flat Dose): 1 x 10e9 CAR T cells. The proposed escalation dose of Cohort 5 may be evaluated, if needed, based on ongoing safety and efficacy data.

Group II: Cohort 4Experimental Treatment1 Intervention

AIC100 CAR T Cell Dose Level 4 (Flat Dose): 7.5 x 10e8 CAR T cells. The proposed escalation dose of Cohort 4 may be evaluated, if needed, based on ongoing safety and efficacy data.

Group III: Cohort 3Experimental Treatment1 Intervention

AIC100 CAR T Cell Dose Level 3 (Flat Dose): 5 x 10e8 CAR T cells

Group IV: Cohort 2.5Experimental Treatment1 Intervention

AIC100 CAR T Cell Dose Level 2.5 (Flat Dose): 2.5 x 10e8 CAR T cells. The interim step-down dose of Cohort 2.5 may be evaluated, if needed, based on ongoing safety and efficacy data.

Group V: Cohort 2Experimental Treatment1 Intervention

AIC100 CAR T Cell Dose Level 2 (Flat Dose): 1 x 10e8 CAR T cells

Group VI: Cohort 1Experimental Treatment1 Intervention

AIC100 CAR T Cell Dose Level 1 (Flat Dose): 1 x 10e7 CAR T cells

Group VII: Cohort -1Experimental Treatment1 Intervention

AIC100 CAR T Cell Dose Level -1 (Flat Dose): 1 x 10e6 CAR T cells

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for thyroid cancer include surgery, radioactive iodine therapy, thyroid hormone therapy, external radiation therapy, chemotherapy, targeted therapy, and immunotherapy. Immunotherapy, such as the investigational AIC100 CAR T cells, works by genetically modifying a patient's T cells to express chimeric antigen receptors (CARs) that specifically target and destroy cancer cells. This approach is significant for thyroid cancer patients, especially those with relapsed or refractory disease, as it offers a personalized treatment option that can potentially overcome resistance to conventional therapies and provide durable responses.

Chimeric antigen receptor-engineered T cells for cancer immunotherapy: progress and challenges.