Actively Recruiting

Early Phase 1
Age: 18Years +
MALE
NCT07156045

Study of Allogeneic Anti-PSMA CAR-NK Cell for Metastatic Castration-Resistant Prostate Cancer

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-01-23

10

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

At present, no cell drug with an indication for mCRPC has been approved for marketing in China, and there is no scholar to fight against it PSMA-CAR-NK cell therapy CRPC was reported in a study. Based on the previous basic research, our company has developed CAR-NK cell injection, hoping to further evaluate its safety, tolerability and preliminary efficacy in the treatment of mCRPC patients in clinical studies, and provide new possibilities for the selection of clinical treatment strategies

CONDITIONS

Official Title

Study of Allogeneic Anti-PSMA CAR-NK Cell for Metastatic Castration-Resistant Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed metastatic castration-resistant prostate cancer (mCRPC)
  • Serum testosterone at castration level (< 50 ng/dL or < 1.7 nmol/L)
  • Positive expression of PSMA
  • Disease progression after castration meeting one of the following: 3 consecutive PSA increases (each >50% increase and PSA >2 ng/mL), progression of bone disease with 2+ new lesions on bone scan, or measurable metastasis on CT/MRI
  • Expected survival time of at least 6 months
  • Recovery to ≤ grade 1 toxicity from previous treatments (except hair loss and hearing loss)
  • ECOG performance status score of 0 to 2
  • Willingness to participate voluntarily and follow trial treatment and visit plans
Not Eligible

You will not qualify if you...

  • Previous treatment with other cell therapy products (e.g., dendritic cells, CIK cells, T cells, NK cells, CAR-T)
  • History of allergy to biological macromolecule drugs
  • Abnormal major organ function including: neutrophil count <1.5×10⁹/L, platelet count <100×10⁹/L, hemoglobin <9 g/dL, liver enzymes ALT or AST >2.5× upper limit of normal (>5× if liver metastases), serum creatinine >1.5× upper limit of normal, blood clotting abnormalities (PT >15 s, APTT prolonged or shortened >10 s, INR >1.7), severe lung diseases
  • Prior treatment with any PSMA-targeted therapy
  • Active autoimmune diseases or need for long-term immunosuppressive therapy
  • Other active malignancies in past 5 years except basal or squamous cell skin cancer
  • Active infections requiring treatment or recent antibiotic use
  • Untreated or active hepatitis B or C infections
  • Participation in other clinical trials with study drugs within past 3 months
  • Inability to use effective contraception
  • Other factors judged unsuitable by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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