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CAR T-cell Therapy

1/ KRAS TCR + vaccine for Ovarian 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:

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Safety

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

Fludarabine

2012

Completed Phase 3

~1100

Aldesleukin

2012

Completed Phase 4

~1620

Cyclophosphamide

1995

Completed Phase 3

~3770

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,231 Total Patients Enrolled

287 Trials studying Ovarian Cancer

73,622 Patients Enrolled for Ovarian Cancer

Steven A Rosenberg, M.D.Principal InvestigatorNational Cancer Institute (NCI)

37 Previous Clinical Trials

17,671 Total Patients Enrolled

4 Trials studying Ovarian Cancer

286 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

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

Do I meet the necessary criteria to participate in this medical study?

"Candidates eligible for this study must have a diagnosis of gastrointestinal cancer and be between 18 and 72 years old. The trial aims to recruit a total of 210 participants."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"As per the details on clinicaltrials.gov, patient recruitment for this study is currently closed. The trial was first listed on March 15th, 2024, with the latest update made on February 9th, 2024. While this specific trial has concluded its search for participants, it's worth noting that there are presently an additional 3549 trials actively seeking candidates."

Answered by AI

Are individuals aged 55 and above eligible to participate in this study?

"For this particular research project, individuals must be at least 18 years old but not exceed the age of 72 to be eligible for participation."

Answered by AI

Has the 1/ KRAS TCR + vaccine received official authorization from the FDA?

"On a scale from 1 to 3, our team at Power has rated the safety of the KRAS TCR + vaccine as a level 1. This is attributed to its Phase 1 trial status and therefore limited data on both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer

2024. "Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06253520.