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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years post-infusion
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for people with thyroid cancer that has returned or does not respond to other treatments.
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.Check my eligibility
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.See study design
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 belowSelect...
My thyroid cancer tests positive for ICAM-1.
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I can take care of myself and am up and about more than half of my waking hours.
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I am willing and able to join the study and can sign the consent form.
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My cancer can be measured on scans.
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I am 18 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine recommended phase 2 dose
Incidence of anticipated AIC100 CAR T Cell related AEs, SAEs and adverse events of special interest (AESI)
Incidence of overall Grade >=3 Adverse Events (AE) and Serious Adverse Events (SAE)
Secondary outcome measures
Assessment of presence and frequency of AIC100 CAR T cells in peripheral blood and tumor samples (when available)
Trial Design
6Treatment groups
Experimental Treatment
Group I: 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 II: Cohort 3Experimental Treatment1 Intervention
AIC100 CAR T Cell Dose Level 3 (Flat Dose): 5 x 10e8 CAR T cells
Group III: 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 IV: Cohort 2Experimental Treatment1 Intervention
AIC100 CAR T Cell Dose Level 2 (Flat Dose): 1 x 10e8 CAR T cells
Group V: Cohort 1Experimental Treatment1 Intervention
AIC100 CAR T Cell Dose Level 1 (Flat Dose): 1 x 10e7 CAR T cells
Group VI: Cohort -1Experimental Treatment1 Intervention
AIC100 CAR T Cell Dose Level -1 (Flat Dose): 1 x 10e6 CAR T cells
Find a Location
Who is running the clinical trial?
AffyImmune Therapeutics, Inc.Lead Sponsor
Koen van Besien, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
6 Previous Clinical Trials
328 Total Patients Enrolled
Koen Van Besien, MD PhDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to chemotherapy drugs or any components of AIC100 CAR T Cells.My liver, kidneys, heart, blood, and bone marrow are all working well.I do not have severe chronic diseases like kidney, liver, heart, or lung conditions.Women who could become pregnant must have a negative pregnancy test.My thyroid cancer tests positive for ICAM-1.I can take care of myself and am up and about more than half of my waking hours.I have not had gene or CAR T cell therapy before.I have waited the required time after my last cancer treatment before starting a new one.I am willing and able to join the study and can sign the consent form.I have previously been treated with specific targeted cancer therapies.I haven't taken immunosuppressants for my autoimmune disease in the last 4 weeks.My cancer can be measured on scans.I am not pregnant or breastfeeding.I have not had gene or genetically modified cell therapy.I am 18 years old or older.I agree to use effective birth control methods.I do not have any serious or uncontrolled infections.I have an active brain or spinal cord disorder that affects my daily life.I have not had any other cancer in the last 2 years.I need to take more than 10 mg/day of prednisone or a similar medication for a long time.I received a COVID-19 vaccine within the last 4 weeks.You are expected to live for more than 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 3
- Group 3: Cohort 2.5
- Group 4: Cohort 4
- Group 5: Cohort -1
- Group 6: Cohort 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary purpose of this experiment?
"According to AffyImmune Therapeutics, Inc., this trial will monitor the occurrence of CAR T-related adverse events and special interest (AESI) over a 42 day period. Secondary assessments include assessing cellular infiltrate in biopsies taken at the beginning and end of treatment or upon progression, evaluating correlations between plasma cytokine levels with both CAR T levels and clinical tumor responses by means of ELISA assays."
Answered by AI
Does this experiment offer opportunities for patient participation right now?
"According to clinicaltrials.gov, this medical research is currently recruiting participants from the date it was first published on September 28th 2020 until August 22nd 2022."
Answered by AI
Has the use of AIC100 CAR T Cells obtained clearance from public health agencies?
"Due to the limited evidence available for AIC100 CAR T Cells, our team assigned it a rating of 1 on a scale from 1 to 3. This is because Phase I trials only provide initial safety and efficacy data."
Answered by AI
How many individuals are engaging in this clinical trial?
"Indeed, the clinicaltrials.gov webpage specifies that this trial is actively searching for volunteers to participate. This study was initially advertised on September 28th 2020 and amended most recently on August 22nd 2022; 24 participants are sought from 2 distinct sites."
Answered by AI
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