Clinical trial · Interventional
PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytokine support | Drug | — | UNRESOLVED |
| EB-PT-CAR-NK-D | Biological | — | UNRESOLVED |
| EB-PT-CAR-NK-S | Biological | — | UNRESOLVED |
| Lymphodepleting chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Single-target precision-matched CAR-NK
- description
- Participants with a single dominant tumor antigen (above a prespecified threshold) receive a matched single-target CAR-NK product manufactured from a healthy donor NK-cell source.
- interventionNames
- Biological: EB-PT-CAR-NK-S
- Biological: EB-PT-CAR-NK-D
- Drug: Lymphodepleting chemotherapy
- Drug: Cytokine support
- type
- EXPERIMENTAL
- label
- Arm B: Dual-target precision-matched CAR-NK
- description
- Participants with co-expression of two target antigens (or high antigen heterogeneity) receive a dual-target CAR-NK product designed to recognize both antigens (e.g., tandem CAR or bicistronic CAR configuration).
- interventionNames
- Biological: EB-PT-CAR-NK-S
- Biological: EB-PT-CAR-NK-D
- Drug: Lymphodepleting chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available