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

Who is this study for? Patients with relapsed and/or refractory advanced thyroid cancer and anaplastic thyroid cancer
What treatments are being studied? AIC100 CAR T Cells
Status: Active_not_recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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.

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

• Life expectancy greater than 8 weeks

• Overall adequate hepatic, renal, bone marrow, cardiac, and coagulation function, defined as the following:

∙ Estimated creatinine clearance ≥ 50 mL/minute

‣ Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST): normal or Grade 1. Note: Lymphodepleting Chemotherapy (LDC) agents can cause fluctuations in hepatic enzymes.

‣ Serum total bilirubin: normal or Grade 1. Note: LDC agents can cause fluctuations in hepatic enzymes.

‣ Serum albumin: normal or Grade 1. (human albumin supplementation is not allowed within 2 weeks prior to Screening assessment)

‣ Hemodynamically stable and left ventricular ejection fraction ≥ 45%

‣ Hematological parameters

• i. Absolute neutrophil count \> 1000/μL without myeloid growth factor support for ≥ 2 weeks

• ii. Absolute lymphocyte count ≥ 100/μL at screening and at apheresis

• iii. Platelet count ≥ 50 × 1000/μL without platelet transfusion for ≥ 2 weeks

• iv. Hemoglobin concentration \> 7 g/dL without red blood cell transfusion for ≥ 2 weeks

• Has met the minimum washout time for previous cancer treatments before undergoing apheresis or LDC, and in the Investigator's judgement, the patient is able to safely undergo the procedure

• (incorporated into inclusion criteria #7)

⁃ Females of reproductive potential (defined as all females physiologically capable of becoming pregnant) must agree to use 1 highly effective method of contraception and 1 additional effective method from at least 30 days before enrollment/apheresis and for at least 1 year after the infusion of AIC100 CAR T Cells.

⁃ Females of reproductive potential must have a negative serum beta-human chorionic gonadotropin pregnancy test result at Screening

Locations
United States
California
City of Hope National Medical Center, City of Hope Medical Center
Duarte
Illinois
Northwestern Memorial Hospital
Chicago
New York
Weill Cornell Medical College
New York
Texas
MD Anderson Cancer Center
Houston
Time Frame
Start Date: 2020-09-28
Completion Date: 2030-08-04
Participants
Target number of participants: 70
Treatments
Experimental: Cohort -1
AIC100 CAR T Cell Dose Level -1 (Flat Dose): 1 x 10e6 CAR T cells
Experimental: Cohort 1
AIC100 CAR T Cell Dose Level 1 (Flat Dose): 1 x 10e7 CAR T cells
Experimental: Cohort 2
AIC100 CAR T Cell Dose Level 2 (Flat Dose): 1 x 10e8 CAR T cells
Experimental: Cohort 3
AIC100 CAR T Cell Dose Level 3 (Flat Dose): 5 x 10e8 CAR T cells
Experimental: Cohort 2.5
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.
Experimental: Cohort 4
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.
Experimental: Cohort 5
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.
Authors
Koen van Besien
Sponsors
Leads: AffyImmune Therapeutics, Inc.

This content was sourced from clinicaltrials.gov