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CAR T-cell Therapy

Adoptive Cell Transfer + Interleukin 2 for Cancer

Phase 1

Recruiting

Led By Ezra Cohen, MD

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.

Must not have

Patient has any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).

Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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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My melanoma cannot be surgically removed and is in stage III or IV.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that significantly weakens my immune system.

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I need medication to suppress my immune system, including steroids.

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I am pregnant or breastfeeding.

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I have undergone cell transfer therapy with intense chemotherapy.

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I have had heart surgery or symptoms due to poor blood flow.

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I have infections due to a weakened immune system.

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I do not have active infections, bleeding disorders, or serious heart, lung, or immune diseases.

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I have a serious heart rhythm problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: melanomaExperimental Treatment2 Interventions

Group II: head and neck cancerExperimental Treatment2 Interventions

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gregory DanielsLead Sponsor

1 Previous Clinical Trials

25 Total Patients Enrolled

Immunotherapy FoundationUNKNOWN

Ezra Cohen, MDPrincipal InvestigatorUniversity of California, San Diego

13 Previous Clinical Trials

739 Total Patients Enrolled

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