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Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer

ConditionsMetastatic Castration-resistant Prostate CancerAdvanced Prostate AdenocarcinomaPSCA-positive Prostate CancerPSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorBeijing Biotech

About this trial

This example Phase 1 study is designed to evaluate the safety, tolerability, feasibility, and preliminary anti-tumor activity of ETB-DualNK-01, an allogeneic dual-target PSMA/PSCA CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer (mCRPC). Part A uses dose escalation to determine the maximum tolerated dose and/or recommended Phase 2 dose. Part B expands at the selected dose in biomarkerconfirmed disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male participant age 18 years or older.

Histologically or cytologically confirmed prostate adenocarcinoma with metastatic castration-resistant disease.

Disease progression by PCWG3 while maintaining castrate testosterone (<50 ng/dL) with ongoing androgen deprivation therapy or prior orchiectomy.

Documented PSMA and/or PSCA expression by a validated tumor assay; PSMA PET may support target confirmation when applicable.

Disqualifiers

Active central nervous system metastases or leptomeningeal disease.

Dominant small-cell or neuroendocrine prostate cancer histology.

Prior gene-modified cellular therapy within 6 months before lymphodepletion, or prior allogeneic transplant requiring ongoing systemic immunosuppression.

Active autoimmune disease requiring systemic treatment or chronic immunosuppression; systemic corticosteroid use greater than 10 mg prednisone equivalent daily within 7 days of lymphodepletion.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ETB-DualNK-01

    Biological/Vaccine

    Allogeneic dual-target antiPSMA/PSCA CAR-NK cells administered intravenously on Day 0; repeat infusion permitted only per protocol in Part B.

  • Fludarabine

    Drug

    Lymphodepletion regimen: 30 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion.

  • Cyclophosphamide

    Drug

    Lymphodepletion regimen: 300 mg/m2/day IV on Days -5 to -3 before ETB-DualNK-01 infusion

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Dose EscalationExperimental treatment 3 interventions
Group B: Dose ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs)

Time frame
28 days
2

Incidence of treatment-emergent adverse events

Time frame
12 months
3

Determination of maximum tolerated dose (MTD)

Time frame
12 months

Secondary outcomes

1

Overall response rate by RECIST 1.1

Time frame
12 months
2

Radiographic progression-free survival (rPFS)

Time frame
12 months
3

Duration of response

Time frame
12 months
4

Overall survival

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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