Biomarker-guided donor CAR-NK therapy targeting one or two tumor antigens for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, biomarker-driven Phase 1/2 program that uses tumor antigen profiling from tissue and/or liquid biopsy to choose a single-target or dual-target CAR-NK product for each participant. Healthy donor NK cells are collected, expanded, genetically modified to express one or two CARs, cryopreserved, and released after quality testing. Participants receive lymphodepleting chemotherapy followed by CAR-NK infusion(s) with optional low-dose cytokine support to promote persistence. The trial focuses on safety, feasibility, and preliminary anti-tumor activity in antigen-positive, relapsed/refractory solid tumor patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .
* 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.
* Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).
* Pregnant or breastfeeding.

Where it's running

• District One Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Rhoda M Smith, PHD
• Email: clinical-trials@essen-biotech.com
• Phone: +12077706670

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.