Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors

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

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.

Conditions15

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