NCT07410494RecruitingPhase 1/2
Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy 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)
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- First submitted
- 8 Feb 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 28 Dec 2027
- Lead sponsor
- Essen Biotech
- Diseases
- Prostate cancer, Follicular lymphoma, Melanoma, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Multiple myeloma, Glioblastoma, Ovarian cancer, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07410494
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 85
- From 1 Feb 2026 to the primary completion date, 28 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .
- Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).
Other illness
- 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.
Other
- Pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 8 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| District One Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.