40 Participants NeededMy employer runs this trial

LNK001 for Renal Cell Carcinoma

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 tests a new treatment called LNK001 for renal cell carcinoma (RCC), a type of kidney cancer. The first part of the study seeks to determine the optimal dose of LNK001, while the second part evaluates whether that dose can effectively control the disease. It targets patients with metastatic cancer who have not responded to previous treatments. Participants should have undergone specific cancer therapies and possess certain tumor characteristics. This trial may suit those seeking new options to manage advanced kidney cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it allows for certain medications like anticoagulants if they are stable, and replacement therapies like thyroxine or insulin. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that LNK001 is likely to be safe for humans?

Research has shown that LNK001, a type of CAR-T cell therapy, is being tested for safety in people with kidney cancer, known as renal cell carcinoma (RCC). The study aims to determine if LNK001 has manageable side effects. CAR-T cell therapy uses specially modified immune cells to attack cancer cells.

Early results suggest this therapy is designed to be more precise and safer for treating solid tumors like RCC. The goal is to target cancer cells while minimizing damage to healthy cells. Although detailed information on side effects from this trial isn't available yet, the trial is in its early stages. Researchers are closely monitoring participants to assess their tolerance to LNK001.

Since LNK001 is in the first phase of testing, this phase primarily focuses on safety. The experiences of participants in this trial will help determine if the treatment is safe enough for further studies.12345

Why do researchers think this study treatment might be promising?

Unlike other treatments for renal cell carcinoma, which often include targeted therapies like tyrosine kinase inhibitors or immune checkpoint inhibitors, LNK001 is a CAR-T cell therapy. This means it uses genetically modified T-cells to specifically target and destroy cancer cells, offering a more personalized approach. Researchers are excited because this method has the potential to provide more precise and effective treatment by harnessing the body's own immune system to fight the cancer. Additionally, CAR-T therapies can offer long-lasting effects after a single treatment, which is a significant advantage over current options that may require ongoing administration.

What evidence suggests that LNK001 might be an effective treatment for renal cell carcinoma?

Research has shown that LNK001, the investigational treatment in this trial, targets two specific proteins commonly found in kidney cancer tumors. This precise targeting helps the treatment attack cancer cells more effectively. Studies on similar CAR-T therapies have shown promise in treating various cancers, including blood cancers, by harnessing the body's immune system to fight the disease. Although data on LNK001's effectiveness in humans remains limited, its unique targeting method offers hope for better control of kidney cancer tumors. Early signs suggest it could be a promising approach to tackling this type of cancer.12346

Who Is on the Research Team?

SA

Samer A Srour, MBBCH

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic clear cell kidney cancer who have already tried at least one treatment, including an immune therapy and a targeted drug. Participants need to have enough healthy blood cells, good liver function, and a tumor that shows high CAIX protein levels.

Inclusion Criteria

I have had disease progression after one treatment, or stopped later treatments due to side effects.
I am 18 years old or older.
* Hemoglobin ≥ 8 g/dl
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Determine the recommended dose of LNK001 in patients with advanced or metastatic ccRCC

Variable duration until recommended dose is determined

Dose Expansion

Assess if the recommended dose of LNK001 can help control the disease

Variable duration based on patient response

Follow-up

Participants are monitored for safety and effectiveness after treatment

Average of 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • LNK001

Trial Overview

The study tests different doses of LNK001 (a new drug) along with cyclophosphamide and fludarabine in two parts: first to find the safest dose, then to see if it helps control kidney cancer. All participants receive these drugs by set schedules.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Part 1/2: ESC/EXP treatment with CAR-T LNK001Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Link Cell Therapies Launches with Vision of Advancing ...

LNK001 targets two antigens that are uniquely and highly co-expressed in most RCC tumors. LNK001 is designed to enable tumor-specific efficacy ...

What's New in Kidney Cancer Research

This potent regimen significantly improved progression-free survival to 16.6 months compared to 11.2 months with nivolumab and ipilimumab alone.

Phase 1 Study Of LNK001 In Advanced Or Metastatic Clear ...

Although the clinical benefit of LNK001 has not yet been established, the intent of offering this treatment is to provide a possible therapeutic ...

LNK001 for Renal Cell Carcinoma · Info for Participants

This Phase 1 medical study run by M.D. Anderson Cancer Center needs participants to evaluate whether LNK001 will have tolerable side effects ...

Current and future perspectives on CAR-T cell therapy ... - PMC

Results have shown that 15% to 30% of patients who received high-dose IL-2 obtained OR, while CR was reached in 5% to 8% of patients [76,77,78]. Interferons are ...

A PHASE 1B STUDY EVALUATING THE SAFETY AND ...

An allogeneic anti-CD70 CAR-T cell product will be evaluated for the treatment of advanced or metastatic clear cell renal cell carcinoma (ccRCC). Indication