TRICK-NK + T-Dxd for Breast Cancer

BL
Overseen ByBora Lim, 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 examines a new treatment combination for individuals with advanced breast cancer. The researchers aim to determine the safest dose of TRICK-NK (a type of therapy) when combined with T-Dxd and to assess whether this combination can control the disease. Initially, the trial will test various doses to identify the most tolerable one, then evaluate if that dose effectively manages the cancer. Individuals with breast cancer that has spread or cannot be surgically removed, and who have not found success with other treatments, might be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be at least 2 weeks from your last dose of certain cancer treatments like chemotherapy or targeted therapies before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, trastuzumab deruxtecan (T-Dxd) proved safe for treating breast cancer. Reports indicate that many patients tolerate it well. For example, real-world data show that most patients don't need to stop treatment due to side effects. Specifically, 94.1% of patients treated with T-Dxd were alive after one year, demonstrating its effectiveness and reasonable safety.

For the TRICK-NK treatment, specific safety data in humans isn't available yet because it remains in early testing (Phase 1). This phase typically assesses a treatment's safety. So far, no major issues have emerged, but this phase is crucial for determining the safest dose when combined with T-Dxd.

Overall, T-Dxd has strong support for its safety, while TRICK-NK is still under careful study to ensure its safe use.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about TRICK-NK + T-Dxd for breast cancer because these treatments offer a novel approach compared to conventional therapies. Traditional treatments often involve chemotherapy or hormone therapies, but TRICK-NK uses engineered natural killer cells that are designed to specifically target and destroy cancer cells. Meanwhile, T-Dxd is an antibody-drug conjugate that directly delivers chemotherapy to cancer cells, potentially reducing damage to healthy cells. This combination could enhance effectiveness and minimize side effects, offering a promising new avenue for patients battling breast cancer.

What evidence suggests that this trial's treatments could be effective for advanced breast cancer?

Studies have shown that T-Dxd, a treatment for breast cancer, delivers strong results. In one study, 71.4% of patients responded well, and 95.2% maintained disease control. Another study found that patients lived over seven months without cancer progression. TRICK-NK, a newer treatment, uses modified immune cells to attack cancer cells. This trial will explore combining TRICK-NK with T-Dxd to assess potential improvements in treatment effectiveness. Although TRICK-NK is still new, the promising results of T-Dxd provide a solid basis for its use in advanced breast cancer.16789

Who Is on the Research Team?

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Bora Lim, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced or metastatic breast cancer that can't be removed by surgery and no longer responds to standard treatments. Participants need good kidney and liver function, measurable tumors, good physical health, and must be a few weeks out from prior therapies.

Inclusion Criteria

My kidney function is normal or only mildly reduced.
My liver tests are within the allowed range and I do not have liver cirrhosis.
I have metastatic or inoperable breast cancer with no effective standard treatments left.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of TRICK-NK in combination with T-Dxd to determine the maximum tolerated dose

21 days per cycle
Multiple visits for dose administration and monitoring

Dose Expansion

Participants receive the recommended phase 2 dose (RP2D) of TRICK-NK in combination with T-Dxd to evaluate safety and preliminary efficacy

21 days per cycle
Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • T-Dxd
  • TRICK-NK

Trial Overview

Researchers are testing the safety and best dose of a new cell therapy called TRICK-NK given with two doses of T-DXd in people with treatment-resistant breast cancer. The study has phases to find the right dose and see if it helps control the disease.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Dose Expansion Phase Cohort A and B: Treatment with TRICK-NK + T-Dxd (21 Days Interval)Experimental Treatment3 Interventions
Group II: Dose Escalation Phase: Treatment with TRICK-NK + T-Dxd (21 Days Interval)Experimental 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

Phase 1b Study Of TRICK-NK In Combination With T-Dxd ...

The goal of this clinical research study is to find the highest tolerable dose of TGFBR-2 KO CD70 CAR NK (TRICK-NK) in combination with 2 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41835339/

Real-world outcomes of trastuzumab deruxtecan in ...

The objective response rate was 71.4%, and the disease control rate was 95.2%. Patients receiving T-DXd in the second line experienced ...

TRICK-NK + T-Dxd for Breast Cancer

The goal of this clinical research study is to find the highest tolerable dose of TGFBR-2 KO CD70 CAR NK (TRICK-NK) in combination with 2 ...

T-DXd Demonstrates Real-World Efficacy in HER2-Low ...

For the whole population, the median progression-free survival (PFS) was 7.4 months. When broken down by HR status, it was 7.7 months for those ...

Real-world efficacy and safety of trastuzumab deruxtecan ...

In this real-world study, T-DXd was more effective than T-DM1 as a second-line treatment and tucatinib as a third-line treatment, in line with ...

The safety of trastuzumab deruxtecan (T‐DXd) in breast ... - PMC

Although trastuzumab deruxtecan (T‐DXd) demonstrated unprecedented intracranial efficacy in HER2‐positive breast cancer brain metastases ...

Trastuzumab deruxtecan in advanced breast cancer - PMC - NIH

Among 104 patients, the median progression-free survival was 8.8 months in those with HER2-low expression, whereas HER2-positive patients exhibited a longer ...

Trastuzumab deruxtecan in HER2-positive advanced ...

These data show substantial and durable overall and intracranial activity for T-DXd, supporting its use in previously treated patients with HER2 + mBC.

T-DXd Continues to Show Superior Outcomes in HER2- ...

T-DXd reduced the risk of death by 36% compared with T-DM1. Of the patients who received T-DXd, 94.1% were alive after one year and 77.4% were ...