This Phase 1/2, open-label, biomarker-guided platform study evaluates the safety, tolerability, and preliminary anti-tumor activity of banked allogeneic donor-derived chimeric antigen receptor natural killer (CAR-NK) cells in adults with advanced solid tumors. During screening, tumor antigen profiling is performed using tissue biopsy and/or liquid biopsy (circulating tumor DNA and/or circulating tumor cells).
Participants are assigned to receive either a single-target CAR-NK product (matched to the dominant tumor antigen) or a dual-target CAR-NK product (matched to two co-expressed antigens) to reduce the risk of antigen escape.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose- limiting toxicities — 28 days Dose limiting toxicities refer to specific adverse events or side effects that prevent further dose escalation of an investigational drug or therapy in a clinical trial. DLTs are pre-defined based on severity, duration, and impact on patient safety, typically graded according to established criteria such as the Common Terminology Criteria for Adverse Events (CTCAE). Monitoring DLTs is a critical outcome measure in early-phase (Phase I/II) studies, as it helps determine the maximum tolerated dose (MTD) and guides safe dosing for subsequent trial phases.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.