Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT06193486

Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-31

30

Participants Needed

1

Research Sites

476 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase 1 single center clinical trial for patients with end stage Metastatic Castration Resistant Prostate Cancer who have progressed through standard of care treatment options and are on zoledronate for bone metastases. This clinical trial includes a dose-escalation phase and dose-expansion phase to assess the safety and preliminary efficacy of treatment with autologous T cells genetically modified to express Prostate stem cell antigen.

CONDITIONS

Official Title

Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients with metastatic castration-resistant prostate cancer (CRPC) to the bone showing progression on imaging per PCWG3 criteria
  • Prior treatment including at least one chemotherapy and one new androgen receptor targeted therapy (abiraterone, enzalutamide, apalutamide, or darolutamide)
  • If on zoledronic acid, must receive a booster dose if last dose was more than 4 weeks before lymphodepletion chemotherapy
  • If on denosumab, must switch to zoledronic acid and receive at least one dose before lymphodepletion chemotherapy
  • If not on zoledronic acid or denosumab, must receive at least two doses of zoledronic acid every 4 weeks before lymphodepletion chemotherapy
  • Zoledronic acid is recommended to be withheld before week 8 after treatment and resumed at physician's discretion thereafter
  • No anticancer therapy in 3 weeks before T cell infusion; no Radium 223 or Puvicto within 3 months; no checkpoint immunotherapy within 6 months prior to infusion
  • Male age 18 years or older
  • ECOG performance status ≤2 or Karnofsky score ≥70%
  • Adequate organ and marrow function as per protocol
  • Life expectancy of at least 6 months
  • Agree to use adequate contraception from screening to 6 months after T cell infusion if child fathering potential exists
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Active hepatitis B infection, history of hepatitis C or HIV infection
  • Dental problems like osteonecrosis of the jaw preventing zoledronic acid use
  • Serious heart conditions including NYHA class 3 or 4 heart failure, recent heart attack, serious arrhythmias, severe cardiomyopathy, or concerning ECG/ECHO findings requiring intervention
  • Active autoimmune diseases except stable autoimmune thyroid disease
  • Leptomeningeal disease or brainstem/brain metastases (except stable, asymptomatic previously irradiated brain lesions)
  • History of significant seizure disorders
  • Concurrent active cancers requiring treatment other than observation
  • Serious uncontrolled medical illness or active uncontrolled infection within 28 days before study treatment
  • History of pancreatitis
  • Any condition deemed by the investigator to make the patient ineligible for the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

G

Gillian Zankel

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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