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Phase 1b Study of TRICK-NK with T-DXd for Advanced Breast Cancers

This study is testing a new combination treatment for advanced breast cancer that has not responded to standard treatments. It combines two drugs: TRICK-NK (TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells) and Trastuzumab deruxtecan (T-DXd). Researchers want to find the safest and most effective dose of TRICK-NK when given with T-DXd. They will also look at how well this combination helps control the cancer. You may be able to join if you have metastatic (spread) or unresectable breast cancer, are at least 18 years old, and have measurable disease. The study is currently unclear on its recruitment status and plans to enroll 60 participants.

Study design
This is an interventional study with a planned enrollment of 60 participants. It has two parts: a dose escalation phase to find the best dose, and a dose expansion phase to see how well that dose works.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07553390

Phase 1b Study Of TRICK-NK In Combination With T-Dxd In Treatment-Refractory Breast Cancers

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~60 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cellsTrastuzumab deruxtecan (T-DXd)Rimiducid

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Bora Lim, MD · PRINCIPAL_INVESTIGATOR · UT MD Anderson

Who to contact

Bora Lim, MD
[email protected]
(713) 745-0689
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure. 16. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 17. Male patients treated or enrolled on this protocol must agree to follow the contraceptive guidelines in Appendix 5 prior to study entry and for the duration of study participation and for 6 months post-TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion. Male patients who father a child or suspect that they have fathered a child must immediately notify their doctor. 18. Willing to undergo mandatory blood collections and biopsies as required by the study. 19. Willing to sign consent for long-term follow-up on protocol PA17-0483. 20. Willing to stay within a 2-hour drive (approximately 100-mile radius) of the study site during the first 4 weeks after the TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0