Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer (NCT04420754) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer
United States70 participantsStarted 2020-09-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing and able to participate in the study and provide written informed consent
✓. Be ≥ 18 years of age on the day of signing the Informed Consent Form
✓. 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:
✓. Anaplastic Thyroid Cancer BRAF wild-type at any stage, including newly diagnosed
✓. Anaplastic Thyroid Cancer BRAF mutant after failure of or inability to tolerate BRAF- specific therapy
✓. Poorly Differentiated Thyroid Cancer that has failed any of the following treatments: surgery radioactive iodine, chemotherapy, radiation therapy, and/or targeted therapies
✓. Measurable disease by Computed Tomography (CT) or Positron Emission Tomography (PET) PET/CT per RECIST v1.1
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Exclusion criteria
✕. Women who are pregnant or breastfeeding
✕. Clinically significant, active, uncontrolled, systemic infection; the following are not exclusionary:
✕. 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
What they're measuring
1
Incidence of overall Grade >=3 Adverse Events (AE) and Serious Adverse Events (SAE)
Timeframe: Up to 1 year post-infusion
2
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)
✕. Patients with chronic hepatitis B virus (HBV) infection must be on antiviral therapy and have an HBV viral load below the limits of detection
✕. Patients with chronic hepatitis C virus (HCV) infection must have completed therapy and have an HCV viral load below the limits of detection
✕. Prior treatment with investigational gene therapy or CAR T cell therapy
✕. Presence of active and clinically relevant central nervous system disorder such as epilepsy, stroke, or symptomatic or uncontrolled brain metastases
✕. 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)