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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an advanced solid tumor that came back or did not respond to standard treatment, or has no standard treatment. The tumor must carry a target marker found by biopsy.
- Age
- 18-75 years (the registry header lists 8 Years to 85 Years).
- Sex
- All sexes can join.
- Disease stage
- Advanced, unresectable or metastatic solid tumor, confirmed by tissue or cell tests. It must be relapsed or refractory after standard therapy, or no standard therapy is available. At least one lesion must be measurable by RECIST 1.1.
- Earlier treatment
- Must have had standard therapy, or have no standard therapy available. Cannot have had gene-modified cell therapy (for example CAR-T or CAR-NK) within a set waiting period.
- Biomarker or test result
- The tumor must be positive for at least one target antigen from the protocol list, found by tissue biopsy and/or liquid biopsy. Positive for at least 2 antigens leads to the dual-target group.
Main reasons for not taking part
- Earlier gene-modified cell therapy (CAR-T, CAR-NK) within the waiting period
- Active uncontrolled infection needing IV antibiotics, uncontrolled HIV, or active HBV/HCV with detectable virus
- Active brain metastases needing rising steroids or urgent care
- Active autoimmune disease needing immune-suppressing treatment
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
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.