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CAR T-cell Therapy

Adoptive Cell Transfer + Interleukin 2 for Cancer

Phase 1
Recruiting
Led By Gregory Daniels, MD, PhD
Research Sponsored by Gregory Daniels
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have advanced head and neck recurrent or metastatic disease.
More than four weeks has elapsed since the patient received any prior systemic therapy at the time of enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

Study Summary

This trial will test whether taking tumor cells and growing them in the lab to create more tumor-fighting cells, which are then put back into the patient, can help fight cancer when the patient's immune system is suppressed.

Who is the study for?
This trial is for adults with advanced melanoma or head and neck cancers that can't be removed by surgery, have progressed after treatment, and are not candidates for curative therapy. They must have a life expectancy over 3 months, no HIV or hepatitis B/C, good organ function, and an ECOG status of 0-1 (fully active to restricted in physically strenuous activity). Pregnant women and those with primary immunodeficiency or certain heart conditions cannot participate.Check my eligibility
What is being tested?
The study tests if tumor fighting cells from the patient's own tumors can combat cancer when reintroduced into their body alongside high-dose interleukin-2 (IL-2), which supports immune response. This adoptive cell transfer aims to see if these lab-grown cells help fight the cancer more effectively.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever, chills, fatigue; complications from high-dose IL-2 like low blood pressure; organ inflammation; increased risk of infection due to suppressed immunity during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My head or neck cancer has returned or spread.
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It has been over four weeks since my last systemic therapy.
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I have up to 3 brain metastases that are stable and treated if needed.
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My melanoma cannot be surgically removed and is in stage III or IV.
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My organs and bone marrow are working well.
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My cancer has worsened after treatment and cannot be cured with known therapies.
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I am fully active or can carry out light work.
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It has been over 6 weeks since my last anti-CTLA4 antibody treatment.
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My condition hasn't improved or has worsened despite treatment.
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My condition worsened after at least one treatment.
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I have been diagnosed with head and neck cancer or melanoma that can be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity
Secondary outcome measures
Overall Response Rate
Progression Free Survival
treatment related Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Group I: melanomaExperimental Treatment2 Interventions
Group II: head and neck cancerExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

Gregory DanielsLead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Immunotherapy FoundationUNKNOWN
Gregory Daniels, MD, PhDPrincipal Investigator - University of California, San Diego
Regents of the University of California - UCSD Medical Group, UCSD Medical Center-Hillcrest, VA San Diego Healthcare System, VA San Diego Medical Center
University of Southern California School Of Medicine (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Autologous Tumor Infiltrating Lymphocytes (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03991741 — Phase 1
Head and Neck Squamous Cell Carcinoma Research Study Groups: melanoma, head and neck cancer
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Autologous Tumor Infiltrating Lymphocytes Highlights & Side Effects. Trial Name: NCT03991741 — Phase 1
Autologous Tumor Infiltrating Lymphocytes (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03991741 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned utilizing Autologous Tumor Infiltrating Lymphocytes?

"The predicted safety of Autologous Tumor Infiltrating Lymphocytes is estimated to be 1 due to its position in Phase 1 trials. This indicates that there has been limited clinical data demonstrating the efficacy and safety of this medication."

Answered by AI

Is participation in this trial still being accepted?

"The clinical trial in question, posted on October 7th 2020 and last updated November 1st 2021, is no longer recruiting volunteers. Nevertheless, there are 2136 other medical studies which are currently open to participants."

Answered by AI
~2 spots leftby Aug 2024