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CAR T-cell Therapy

Genetically Engineered T-Cells + Vaccine for Metastatic Cancer

Phase 1

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

Participants with an appropriate HLA match for available Surgery Branch KRAS TCRs with evaluable metastatic solid cancer (e.g., gastrointestinal, genitourinary, breast, ovarian, non-small cell lung cancer (NSCLC) and other solid cancers) with known KRAS G12V or G12D mutation

Refractory to standard systemic therapy as follows:

Must not have

Women who are pregnant or breastfeeding

Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up response assessed at 4, 8, 12 and 20 weeks post-cell infusion, every 3 months x3, every 6 months x 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new cancer treatment that uses a person's own modified white blood cells along with a vaccine to target specific proteins found in cancer cells. Adults with certain types of cancer that have

Who is the study for?

This trial is for adults aged 18-72 with certain advanced solid tumors like urogenital, gastrointestinal, ovarian, colorectal, non-small cell lung, and breast cancers that have spread despite treatment. Participants must be able to undergo leukapheresis and stay in the hospital for about a month.

What is being tested?

The study tests a personalized cancer treatment combining modified white blood cells targeting specific proteins on cancer cells with a vaccine boosting this effect. Patients will receive chemotherapy before getting their engineered white cells back along with vaccine injections at set intervals.

What are the potential side effects?

Potential side effects include reactions from the gene therapy process, immune responses due to the modified white blood cells or vaccine, chemotherapy-related issues such as nausea and hair loss, and increased risk of infections following treatment.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a KRAS G12V or G12D mutation and matches the HLA type for a specific treatment.

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My condition did not improve after standard treatment.

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I have colorectal cancer and have been treated with oxaliplatin or irinotecan.

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I have had at least two treatments for my breast or ovarian cancer.

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I have NSCLC and have been treated with both platinum-based chemotherapy and an FDA-approved targeted therapy.

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I have up to 3 small, symptom-free brain tumors.

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I am between 18 and 72 years old.

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I am fully active or can carry out light work.

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I agree to use effective birth control.

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I have finished all my previous cancer treatments.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I do not have any active infections, bleeding disorders, or major illnesses that are not under control.

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I have lung cancer or lung metastases without treatable major airway blockage or bleeding.

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I have an autoimmune disease affecting a major organ.

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

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My lung function test shows less than or equal to 50% of what's expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ response assessed at 4, 8, 12 and 20 weeks post-cell infusion, every 3 months x3, every 6 months x 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~response assessed at 4, 8, 12 and 20 weeks post-cell infusion, every 3 months x3, every 6 months x 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and response assessed at 4, 8, 12 and 20 weeks post-cell infusion, every 3 months x3, every 6 months x 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complete response (CR) and/ or partial response (PR)

Secondary study objectives

Safety

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/ KRAS TCR + vaccineExperimental Treatment5 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + KRAS TCR-Transduced PBL + high-dose aldesleukin + vaccine (Day 0, weeks 4 and 8 and at week 12 (if no progression)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aldesleukin

2012

Completed Phase 4

~1610

Fludarabine

2012

Completed Phase 4

~1860