TRICK-NK + T-Dxd for Breast Cancer

Overseen By Bora Lim, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anti-arrhythmics, Immunosuppressants, Steroids, others

Disqualifiers: Hepatitis B/C, HIV, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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 doses of T-Dxd that can be given to participants who have advanced breast cancer. The safety of TRICK-NK will also be studied.

The goal of Part 1 (dose escalation) of this clinical research study is to find the highest tolerable dose of TRICK-NK (in combination with T-Dxd) that can be given to participants who have advanced breast cancer.

The goal of Part 2 (dose expansion) of this clinical research study is to learn if the dose of TRICK-NK found in Part 1 can help to control the disease.

The optional schedule optimization phase will test a shorter interval between the NK cell infusion and the first dose of T-Dxd.

Who Is on the Research Team?

Bora Lim, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

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.

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

How Is the Trial Designed?

Group I: Dose Expansion Phase Cohort A and B: Treatment with TRICK-NK + T-Dxd (21 Days Interval) Experimental Treatment 3 Interventions

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.

Group II: Dose Escalation Phase: Treatment with TRICK-NK + T-Dxd (21 Days Interval) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+