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A Multi Center Phase I study of AIC100 in Relapsed and/or Refractory Advanced Thyroid Cancer and Anaplastic Thyroid Cancer

Clinical Trial Details

The purpose of this study is to determine the safety and recommended dose of AIC100 for treating patients with advanced thyroid cancer or anaplastic thyroid cancer, and to understand the side effects that participants with your disease may have when they are treated with AIC100. There are limited treatment options available for people with these diseases.
   
AIC100 is a Chimeric Antigen Receptor (CAR) T-cell product. This treatment uses your own immune cells, called T cells. T cells fight infections and in some cases, can also kill cancer cells. Currently, your T cells are not able to kill your cancer cells. CAR T-cell products are genetically modified T-cells that can recognize and possibly kill cancer cells.
   
AIC100 is an investigational treatment. “Investigational” means that it is an experimental therapy that has not yet been approved by the United States Food and Drug Administration (FDA).


Key Eligibility: 


 Inclusion Criteria:

  1. Willing and able to participate in the study and provide written informed consent

  2.  Be ≥ 18 years of age on day of signing informed consent

  3. One of the following thyroid malignancies:
    • Anaplastic Thyroid Cancer (ATC) BRAF wild-type at any stage including newly diagnosed
    • Anaplastic Thyroid Cancer (ATC) BRAF mutant after failure of BRAF specific therapy
    • Poorly differentiated thyroid cancer that has failed surgery, radioactive iodine, chemotherapy, radiation therapy and/or targeted therapies

  4. Measurable disease (by CT scan or PET/CT)

  5. ECOG Performance Status 0-2

  6. Life expectancy of greater than 8 weeks


Exclusion Criteria

  1. Women who are pregnant or breastfeeding

  2. Active systemic infections that are not controlled

  3. Previous treatment with investigational gene therapy or chimeric antigen receptor therapy

  4. Presence of active and clinically relevant CNS disorder such as epilepsy, stroke

  5. Evidence of another malignancy within 2 years prior to screening (except in situ non-melanoma skin cell cancers)

  6. Patients with seropositive response of human immunodeficiency virus (HIV) or uncontrolled hepatitis B virus or hepatitis C virus infections

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Ashlee N. Torres, RN
(212) 746-7117
ant9105@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1912021154

ClinicalTrials.gov:

NCT04420754

Status

Open to Enrollment

Age Group

Adult

Sponsor