Biomarker-guided donor CAR-NK therapy targeting one or two tumor antigens for advanced solid tumors
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 treatment tries donor-derived CAR-NK cells that target one or two tumor antigens for adults with advanced solid tumors such as breast, NSCLC, colorectal, and recurrent prostate cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 8 Years to 85 Years |
| Sex | All |
| Sponsor | Essen Biotech Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07410494 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–75 with histologically confirmed advanced, unresectable or metastatic solid tumors that are relapsed/refractory to standard therapy and who have a protocol-specified target antigen on tissue or liquid biopsy, ECOG 0–1 (or 0–2), measurable disease, and adequate organ function.
Not a fit: Patients whose tumors do not express any protocol-specified target antigen, who cannot tolerate lymphodepleting chemotherapy, or who have poor organ function or performance status are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could shrink tumors and provide a new treatment option for patients whose cancers express the selected antigens, potentially with lower immune toxicity than some CAR-T approaches.
How similar studies have performed: Early allogeneic CAR-NK trials in hematologic cancers have shown promising responses, but CAR-NK therapies for solid tumors remain experimental and have limited clinical success so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- District One Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Rhoda M Smith, PHD
- Email: clinical-trials@essen-biotech.com
- Phone: +12077706670
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.