Precision-matched donor CAR-NK cell 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 open-label Phase 1/2 platform uses tumor antigen profiling from tissue biopsy and/or liquid biopsy to match participants to a banked allogeneic CAR‑NK product targeting one or two antigens. The study includes dose-escalation cohorts followed by expansion cohorts, with participants receiving lymphodepleting chemotherapy and one or more CAR‑NK infusions and possible low‑dose cytokine support. Safety, tolerability, and preliminary anti‑tumor activity are closely monitored, including surveillance for cytokine release syndrome and neurologic events, and responses are measured by standard radiologic criteria. Assignment to single- or dual-target products is driven by predefined antigen-expression thresholds to reduce the risk of antigen escape.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 75 years at the time of consent.
* Histologically or cytologically confirmed advanced or metastatic solid tumor that is refractory to, relapsed after, or intolerant of standard therapy, or for which no standard therapy exists.
* At least 1 measurable lesion per RECIST v1.1.
* Tumor antigen positivity documented by tissue biopsy and/or liquid biopsy using a protocol-specified assay; for dual-target cohort: co-expression of both antigens above threshold.
* ECOG performance status 0-1.
* Adequate organ function (hematologic, renal, hepatic) as defined by protocol labs.
* Ability to undergo lymphodepleting chemotherapy (if required) and receive IV cell infusion.
* Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion.
* Willingness to provide baseline blood samples and, when feasible, tumor biopsy for biomarker analyses.

Exclusion Criteria:

* Active, uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection.
* Known uncontrolled HIV infection; active hepatitis B or hepatitis C with evidence of active replication (per local testing).
* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk from lymphodepletion or infusion.
* Active central nervous system (CNS) metastases that are symptomatic or require escalating steroids.

(Stable treated CNS disease may be allowed per protocol.)

* Current systemic immunosuppressive therapy (e.g., \>10 mg/day prednisone equivalent) within a protocol-defined window prior to lymphodepletion.
* Prior gene-modified cellular therapy within 3 months or any prior therapy that, in the investigator's judgment, would confound safety evaluation.
* Prior allogeneic hematopoietic stem cell transplant within 6 months, or active graft-versus-host disease.
* Pregnant or breastfeeding.
* Any condition that, in the investigator's opinion, would interfere with study participation, compliance, or interpretation of results.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: shan S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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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.