Tests donor-derived CAR-NK cells chosen by tumor profile in advanced solid cancers
Tests allogeneic CAR-NK cells, targeting a tumor antigen chosen by biopsy, in advanced solid tumors.
Plain-language title generated from the registry record
Registry title: Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 85 years old?
Source: NCT07410494, who can take part
Where in China
- District One HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Essen Biotech
- Trial code
- NCT07410494
- Record updated
- 18 February 2026
- Original description
This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.Read full original descriptionShow less
A Phase 1/2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and/or Liquid Biopsy Profiling in Participants With Relapsed/Refractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)
This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.
Inclusion: Age 18-75 years; Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available; Targetable antigen positivity from the protocol target menu based on:; tissue biopsy and/or liquid biopsy platform (as defined in the lab manual); Arm assignment rules :; Arm A: ≥1 antigen meets "positive" threshold; Arm B: ≥2 antigens meet "positive" threshold; ECOG performance status 0-1 (or 0-2 ); At least one measurable lesion by RECIST 1.1; Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits; Willingness to undergo blood draws and required biopsies (when medically feasible); Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.
Exclusion: Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period ; Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout); Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy); Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ); Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold; Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk; Pregnant or breastfeeding.