NCT07410494 Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
| NCT ID | NCT07410494 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Essen Biotech |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 85 participants in total. It began in 2026-02-01 with a primary completion date of 2027-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07410494 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 85 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07410494 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07410494 currently recruiting?
Yes, NCT07410494 is actively recruiting participants. Contact the research team at clinical-trials@essen-biotech.com for enrollment information.
Where is the NCT07410494 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07410494 clinical trial?
NCT07410494 is sponsored by Essen Biotech. The trial plans to enroll 85 participants.
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