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Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer | Clinical Trials | Clareo Health

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Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer

A Multicenter Phase I Study of AIC100 CAR T Cells in Relapsed and/or Refractory Advanced Thyroid Cancer or Anaplastic Thyroid Cancer

NCT04420754•AffyImmune Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and tolerability and determine the recommended Phase 2 dose of AIC100 Chimeric Antigen Receptor (CAR) T cells in patients with relapsed/refractory poorly differentiated thyroid cancer and anaplastic thyroid cancer, including newly diagnosed.

Detailed Description

The primary objective of this study is to assess the safety and tolerability of AIC100 CAR T Cells and determine the recommended Phase 2 dose of AIC100 in patients with relapsed/refractory poorly differentiated thyroid cancer and in patients with anaplastic thyroid cancer that are BRAF wild-type, including newly diagnosed, or BRAF mutant anaplastic thyroid cancer after failure of BRAF mutant specific therapy. Upon enrollment, patients will undergo apheresis for collection of autologous lymphocytes. The autologous T cells will be transfected and expanded in vitro to generate the AIC100 CAR T Cell product. After lymphodepleting chemotherapy, AIC100 CAR T Cells will be infused. The study drug product, AIC100, consists of autologous CAR T cells targeting intercellular adhesion molecule-1 (ICAM-1) on thyroid cancer. In addition, AIC100 cells express the somatostatin receptor subtype 2 (SSTR2), which should enable imaging of AIC100 CAR T Cells.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing and able to participate in the study and provide written informed consent
•2. Be ≥ 18 years of age on the day of signing the Informed Consent Form
•3. Patients must have thyroid cancer that meets one of the following diagnoses, and, prior to lymphodepleting chemotherapy (LDC), have an identified available fresh or archival biopsy sample:
•1. Anaplastic Thyroid Cancer BRAF wild-type at any stage, including newly diagnosed
•2. Anaplastic Thyroid Cancer BRAF mutant after failure of or inability to tolerate BRAF- specific therapy
•3. Poorly Differentiated Thyroid Cancer that has failed any of the following treatments: surgery radioactive iodine, chemotherapy, radiation therapy, and/or targeted therapies
•4. Measurable disease by Computed Tomography (CT) or Positron Emission Tomography (PET) PET/CT per RECIST v1.1
•a. For ATC patients who do not have measurable disease at Screening, they are required to have measurable disease at Baseline Day -7 to proceed in the study.
•5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
•6. Life expectancy greater than 8 weeks
+14 more criteria

Exclusion Criteria

•1. Women who are pregnant or breastfeeding
•2. Clinically significant, active, uncontrolled, systemic infection; the following are not exclusionary:
•1. Patients with Human immunodeficiency virus (HIV) must have been on effective antiretroviral therapy for ≥ 4 weeks prior to enrollment; must have an HIV viral load \< 400 copies/µL; no acquired immunodeficiency syndrome related opportunistic infections in the previous 12 months; and a CD4+ cell count ≥ 350 cells/µL
•2. Patients with chronic hepatitis B virus (HBV) infection must be on antiviral therapy and have an HBV viral load below the limits of detection
•3. Patients with chronic hepatitis C virus (HCV) infection must have completed therapy and have an HCV viral load below the limits of detection
•3. Prior treatment with investigational gene therapy or CAR T cell therapy
•4. Presence of active and clinically relevant central nervous system disorder such as epilepsy, stroke, or symptomatic or uncontrolled brain metastases
•5. Evidence of another malignancy within 2 years prior to Screening (except in-situ non melanoma skin cancers, localized controlled prostate cancer, adequately treated Stage 1 uterine cancer that has a low risk of recurrence, or any other malignancies with similar outcome)
•7. Active autoimmune disease (including but not limited to systemic lupus erythematosus, Sjögren's Syndrome, rheumatoid arthritis (RA), psoriasis, multiple sclerosis, inflammatory bowel disease) requiring immunosuppressive therapy within 4 weeks prior to eligibility confirmation
•8. Patients with severe chronic diseases of the kidney, liver, heart, lung; or any other serious illness that, in the opinion of the Investigator, may affect the patient's treatment, follow up, or assessments, including but not limited to uncontrolled clinically significant neurological or psychiatric disorders or metabolic diseases
+6 more criteria

Locations (4)

City of Hope National Medical Center, City of Hope Medical Center

Duarte, California, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Weill Cornell Medical College

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

September 28, 2020

Primary Completion Date

August 4, 2026

Completion Date

August 4, 2030

Last Updated

March 30, 2025

Enrollment

ESTIMATED participants

Conditions

Anaplastic Thyroid CancerRelapsed/Refractory Poorly Differentiated Thyroid Cancer

Interventions

AIC100 CAR T Cells

BIOLOGICAL

Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer

Inclusion Criteria

Exclusion Criteria

Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

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Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer

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Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer

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