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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07553390
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells — DRUG
    Given by IV
  • Trastuzumab deruxtecan (T-DXd) — DRUG
    Given by IV
  • Rimiducid — DRUG
    Given by IV

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Mar 30, 2036
Completion
Mar 30, 2038

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Phase: Treatment with TRICK-NK + T-Dxd (21 Days Interval)
    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.
  • Experimental: Dose Expansion Phase Cohort A and B: Treatment with TRICK-NK + T-Dxd (21 Days Interval)
    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.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
Bora Lim, MD
[email protected]
713-745-0689
Bora Lim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UT MD Anderson· Houston, TX

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