Precision-matched donor CAR-NK cell therapy targeting one or two tumor antigens for advanced solid tumors
A Phase 1/2 Biomarker-Guided Platform Study of Allogeneic Donor-Derived Single-Target or Dual-Target CAR-NK Cell Therapy Selected by Tumor Antigen Profiling (Liquid Biopsy and/or Tissue Biopsy) in Participants With Advanced Solid Tumors
This trial tests banked donor CAR‑NK cell infusions matched to the antigens in an adult's tumor to see if they are safe and can shrink advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing Biotech Industry-sponsored |
| Drugs / interventions | chemotherapy, prednisone, chimeric antigen receptor, cyclophosphamide, fludarabine |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07510828 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–75 with histologically confirmed advanced or metastatic solid tumors refractory to or lacking standard options, with at least one measurable lesion, ECOG 0–1, adequate organ function, and tumor antigen positivity by tissue or liquid biopsy are the intended candidates.
Not a fit: Patients whose tumors do not express the target antigens, who cannot tolerate lymphodepleting chemotherapy, or who have poor organ function or ECOG >1 are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a targeted cell therapy that more precisely attacks tumor cells and reduces antigen escape by matching CAR‑NK products to each patient's tumor profile.
How similar studies have performed: Early-phase CAR‑NK and multi-target CAR approaches in solid tumors have shown acceptable safety signals in some trials but limited durable responses to date, so this precision-matched approach remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shenzhen, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.