Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC

Sponsor
Beijing Biotech
Study ID
NCT07510802
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dual-target CAR-NK cells — BIOLOGICAL
    Route: IV infusion. Schedule: single infusion on Day 0; optional second infusion on Day 7 in the absence of dose-limiting toxicity (DLT) and with adequate clinical status.
  • Lymphodepleting — DRUG
    chemotherapy - fludarabine (Days -5 to -3) and cyclophosphamide (Days -5 to -4), prior to CAR-NK infusion.
  • Supportive care — OTHER
    Premedication per institutional standard (e.g., acetaminophen and antihistamine). Tumor lysis and infection prophylaxis per institutional guidelines.

Study Details

This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer. After a tumor antigen assessment (HER2/ERBB2, MUC1, ROR1,TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.

Key Dates

First listed
Apr 6, 2026
Start date
Feb 2, 2026
Status verified
Mar 2026
Primary completion
Mar 14, 2027
Completion
Apr 17, 2028

Study Design

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

Arms

  • Experimental: Dose Escalation
    Advanced/metastatic breast cancer with measurable disease and expression of at least one target antigen (HER2, MUC1, or ROR1). Participants receive lymphodepletion followed by a single infusion of dual-target CAR-NK (construct chosen by antigen profile)
  • Experimental: Expansion Cohort A
    HER2-positive breast cancer (HER2 IHC 3+ or IHC 2+ with ISH amplification) with MUC1 expression; receives HER2/MUC1 dual-target CAR-NK at RP2D
  • Experimental: Expansion Cohort B
    HER2-positive breast cancer or HER2-low disease with high ROR1 expression; receives HER2/ROR1 dual-target CAR-NK at RP2D.
  • Experimental: Expansion Cohort C
    Triple-negative breast cancer with MUC1 and/or ROR1 expression; receives MUC1/ROR1 dual-target CAR-NK at RP2D. Exploratory TNBC sub-cohort: mesothelin-positive TNBC may be analyzed separately.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]

Central Contacts

Find similar trials

Nationwide
Breast cancer trialsOncology trialsBreast oncology trialsWomen's health trials

Related Studies