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CAR T-cell Therapy

Gene Transfer Therapy for Metastatic Cancer

Phase 2

Recruiting

Led By Steven A Rosenberg, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 72 years

Clinical performance status of ECOG 0 or 1

Must not have

Pregnant or breastfeeding women of child-bearing potential

Concurrent systemic steroid therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether gene transfer therapy can shrink tumors in people with metastatic cancer.

Who is the study for?

This trial is for adults aged 18-72 with certain metastatic cancers that haven't responded to standard treatments. Participants must be in good physical condition, not have HIV or hepatitis, agree to use birth control, and sign consent forms. Pregnant women and those with major illnesses or hypersensitivity reactions are excluded.

What is being tested?

The study tests gene transfer therapy using the patient's own white blood cells engineered to attack cancer mutations. It involves leukapheresis, cell modification in a lab, hospital treatment including drug administration via catheter, recovery period with medications and follow-up visits.

What are the potential side effects?

Potential side effects include reactions from the infusion of modified cells or drugs like Aldesleukin and Pembrolizumab (KEYTRUDA), which may cause immune system complications, infection risks, organ inflammation, fatigue among others based on individual tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 72 years old.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has spread and can be measured.

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My cancer did not respond to standard treatments.

Exclusion Criteria

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

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I am currently pregnant or breastfeeding.

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I am currently taking steroid medication.

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I have an autoimmune disease affecting a major organ.

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I do not have any active infections, bleeding disorders, or serious illnesses.

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I have had heart surgery or symptoms of reduced blood flow to my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per pi discretion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate

Secondary study objectives

Safety and tolerance

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: 2/iTCR + PembroExperimental Treatment5 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + Individual Patient TCRTransduced PBL + high- or low-dose aldesleukin + pembrolizumab prior to cell administration and 3 additional doses every 3 weeksfollowing cell infusion

Group II: 1/iTCRExperimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + Individual Patient TCR-Transduced PBL + high- or low-dose aldesleukin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310