TRICK-NK + T-Dxd for Breast Cancer
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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of TRICK-NK in combination with T-Dxd to determine the maximum tolerated dose
Dose Expansion
Participants receive the recommended phase 2 dose (RP2D) of TRICK-NK in combination with T-Dxd to evaluate safety and preliminary efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Investigators will enroll two cohorts of participants with up to 15 participants within each cohort to the RP2D to further evaluate the safety and preliminary efficacy.
This phase will be conducted with a maximum of 21 participants to examine three escalating cell dose levels and one de-escalating cell dose level (level -1) with T-Dxd (21 days +/-3 days interval between cell infusion and each dose of T-Dxd treatment), to determine the safety and select the RP2D.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
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 ...
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 ...
4.
onclive.com
onclive.com/view/t-dxd-demonstrates-real-world-efficacy-in-her2-low-metastatic-breast-cancerT-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.
9.
oncologynewscentral.com
oncologynewscentral.com/article/t-dxd-continues-to-show-superior-outcomes-in-her2-positive-breast-cancerT-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 ...
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