Actively Recruiting
PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors
Led by Beijing Biotech · Updated on 2026-04-06
60
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of consent.
- Histologically or cytologically confirmed advanced or metastatic solid tumor refractory or intolerant to standard therapy, or no standard therapy exists.
- At least one measurable tumor lesion per RECIST v1.1.
- Tumor antigen positivity confirmed by tissue or liquid biopsy; dual-target cohort requires co-expression of both antigens above threshold.
- ECOG performance status of 0 or 1.
- Adequate organ function as per protocol laboratory criteria.
- Ability to undergo lymphodepleting chemotherapy and receive intravenous cell infusion.
- Negative pregnancy test for individuals of childbearing potential and agreement to use effective contraception during and after study.
- Willingness to provide baseline blood samples and tumor biopsy when feasible for biomarker studies.
You will not qualify if you...
- Active, uncontrolled bacterial, fungal, or viral infection.
- Known uncontrolled HIV infection or active hepatitis B or C with active replication.
- Clinically significant cardiovascular disease increasing risk from lymphodepletion or infusion.
- Active symptomatic central nervous system metastases requiring escalating steroids (stable treated CNS disease may be allowed).
- Current systemic immunosuppressive therapy exceeding 10 mg/day prednisone equivalent within protocol-defined window before lymphodepletion.
- Prior gene-modified cellular therapy within 3 months or any therapy confounding safety evaluation.
- Prior allogeneic hematopoietic stem cell transplant within 6 months or active graft-versus-host disease.
- Pregnant or breastfeeding.
- Any condition interfering with participation, compliance, or interpretation of results as judged by investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
shan S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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