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CAR T-cell Therapy
CUE-101 + Keytruda for Head and Neck Squamous Cell Carcinoma
Phase 1
Waitlist Available
Research Sponsored by Cue Biopharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, CUE-101, as a possible treatment for HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
Who is the study for?
This trial is for adults over 18 with HPV16+ recurrent or metastatic head and neck squamous cell carcinoma who've had prior systemic therapy. They must have measurable disease, be HLA A*0201 genotype positive, and able to consent to study procedures. Exclusions include HIV/AIDS, hepatitis B/C, other cancers within 2 years, recent major surgery or trauma, significant heart disease, active infections requiring IV treatment, mental incapacity to consent.
What is being tested?
The trial is testing CUE-101 alone as a second-line treatment or in combination with Pembrolizumab (KEYTRUDA®) as a first-line treatment. It's an open-label phase 1 study focusing on safety and effectiveness against HPV16+ head and neck cancer.
What are the potential side effects?
Potential side effects may include immune reactions due to KEYTRUDA®, such as inflammation of organs; infusion-related reactions; fatigue; digestive issues; blood disorders; increased risk of infection. Specific side effects from CUE-101 are not detailed but could overlap with those known from similar treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Limiting Toxicity
Serum PK parameters for CUE-101
Secondary study objectives
Overall response rate (ORR)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pembrolizumab and CUE-101Experimental Treatment2 Interventions
Part C\&D: CUE-101 Dose Escalation in Combination with KEYTRUDA® (pembrolizumab) for injection, for IV use 200 mg Q3W (Part C). Expansion of pembrolizumab plus CUE-101 at the combination RP2D (Part D)
Group II: CUE-101 dose escalation and expansionExperimental Treatment1 Intervention
Part A\&B: CUE-101 Monotherapy IV infusion Q3W Dose Escalation (Part A) and Expansion (Part B)
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Who is running the clinical trial?
Cue BiopharmaLead Sponsor
2 Previous Clinical Trials
82 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,142 Total Patients Enrolled
Matteo Levisetti, MDStudy DirectorCue Biopharma
1 Previous Clinical Trials
52 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Results from medical tests show certain abnormalities or conditions.You have advanced head and neck cancer that has worsened after receiving at least one type of treatment. You must have already received platinum-based chemotherapy and/or pembrolizumab as a first-line treatment.You fully understand the study and have agreed to participate. You are also willing to follow the study procedures and provide the necessary research samples.You need to have a specific genetic marker called HLA A*0201 which will be tested by a designated laboratory chosen by the study sponsor.You are physically able to perform daily activities without assistance, or with minimal assistance.You are expected to live for at least 12 more weeks.You have cancer that has spread to your brain and are experiencing symptoms.You have had a transplant using cells or organs from another person.You have a disease that can be measured using CT or MRI. Skin or subcutaneous lesions can be measured with a ruler. The disease should not have been treated with radiation before or should have shown signs of getting worse since radiation treatment.You have been diagnosed with a specific type of cancer caused by a virus called HPV16 and can provide tissue samples to confirm the diagnosis. The samples will be tested to check for the virus and a specific protein called p16INK4A.You have a significant gastrointestinal (GI) disorder that could impact your ability to participate in the study.Criteria related to pregnancy and fertility.You have an autoimmune disease that needs treatment with medication in the last two years.You received radiation therapy less than 2 weeks before starting the study drug.You must be at least 18 years old.Your blood platelet count is at least 100,000 per microliter.You have had alcohol or drug abuse issues in the past year.You have any health condition or situation that could interfere with the study or make it difficult to get accurate results.
Research Study Groups:
This trial has the following groups:- Group 1: CUE-101 dose escalation and expansion
- Group 2: Pembrolizumab and CUE-101
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.
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