16 Participants NeededMy employer runs this trial

MSK-TCR5 for Cancer

Recruiting at 6 trial locations
AS
CK
Overseen ByChristopher Klebanoff, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new treatment called MSK-TCR5, an experimental therapy for individuals with advanced solid tumors that have specific genetic mutations (KRAS, HRAS, or NRAS G12D). The study will evaluate different doses to determine what is safe and effective. It suits those with advanced solid tumors who have exhausted other treatments that proved ineffective or are no longer beneficial. Participants must have a specific genetic marker and cancer that cannot be surgically removed. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that MSK-TCR5 is likely to be safe for humans?

Without specific data on MSK-TCR5, it's important to note that this trial is in its early stages. Early-stage trials primarily test a treatment's safety. Researchers are still learning about the treatment's safety in humans. However, in early-stage trials, researchers closely monitor any side effects and how well participants tolerate the treatment. Participants typically receive varying doses to determine the safest and most effective dose. Those considering participation should know that their health will be closely monitored to ensure safety.12345

Why do researchers think this study treatment might be promising for cancer?

MSK-TCR5 is unique because it uses a novel approach called T-cell receptor (TCR) therapy to target cancer cells. Unlike traditional treatments like chemotherapy or radiation, which attack both healthy and cancerous cells, TCR therapy aims to enhance the body's immune response specifically against cancer cells. Researchers are excited about MSK-TCR5 because it can be tailored to recognize specific proteins on cancer cells, potentially leading to more effective and personalized treatment with fewer side effects. This precision targeting could offer new hope for patients who haven’t responded to standard therapies.

What evidence suggests that MSK-TCR5 might be an effective treatment for advanced solid tumor cancer?

Research has shown that MSK-TCR5 targets specific changes in cancer cells, such as KRAS, HRAS, or NRAS G12D mutations, commonly found in advanced solid tumors. The treatment aims to locate and attack these cancer cells, potentially shrinking tumors. Early results suggest effectiveness by focusing directly on the genetic errors causing the cancer. Although detailed information from human studies remains limited, the treatment appears promising due to its targeted approach.12367

Who Is on the Research Team?

AS

Adam Schoenfeld, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors that can't be removed by surgery and have a specific RAS G12D gene mutation and HLA-A*11:01 type. Participants must have tried standard treatments first if available, have measurable disease, good physical health, and adequate blood counts.

Inclusion Criteria

Part B: Creatinine clearance ≥50 mL/min by Cockcroft-Gault equation
I have colorectal cancer and have been treated with approved targeted therapies for my tumor type.
I have had FDA-approved targeted or immune therapies for my solid tumor.
See 12 more

Exclusion Criteria

I have not had cancer treatment or radiotherapy in the last 2 weeks.
I do not have untreated or active brain or spinal cord cancer.
I do not have allergies to cyclophosphamide, fludarabine, or related drugs.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MSK-TCR5 therapy at various dose levels to evaluate safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • MSK-TCR5

Trial Overview

The study is testing the safety of MSK-TCR5, a new treatment designed to target cancers with certain genetic mutations (KRAS, HRAS, or NRAS G12D) in people with advanced solid tumors. All participants receive this experimental therapy.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Dose Level 3: 0.3 to 1.0 x 10^11 Cell Dose (cell number)Experimental Treatment1 Intervention
Group II: Dose Level 2: 3.0 x 10^10 Cell Dose (cell number)Experimental Treatment1 Intervention
Group III: Dose Level 1: 1.0 x 10^10 Cell Dose (cell number)Experimental Treatment1 Intervention
Group IV: Dose Level -1: 3.0. x 10^9 Cell Dose (cell number)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

A Study of MSK-TCR5 in People With Solid Tumor Cancers

The purpose of this study is to test the safety of MSK-TCR5 in participants with advance solid tumor cancer that has a KRAS, HRAS, or NRAS G12D mutation.

A Study of MSK-TCR5 in People With Solid Tumor Cancers

We treat every type of cancer, including the most important one: yours. With cancer, where you get treated first matters. From diagnosis to treatment, our ...

MSK-TCR5 for Cancer

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Jessica Scott, PhD Exercise Oncology Service

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A Study of MSK-TCR5 in People With Solid Tumor Cancers

The purpose of this study is to test the safety of MSK-TCR5 in participants with advance solid tumor cancer that has a KRAS, HRAS, or NRAS G12D mutation.

Memorial Sloan Kettering: Data and Safety Monitoring Plan

The following document outlines the policies established by Memorial Sloan Kettering. (MSK) for the appropriate oversight and monitoring of the conduct of ...