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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06193486
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MSGV1-PSCA-8T28Z — BIOLOGICAL
    Autologous Gamma Delta T Cells Genetically Engineered with a Chimeric Receptor to Target the Prostate Stem Cell Antigen.
  • Fludarabine — DRUG
    Fludarabine is an antimetabolite given prior to lymphodepletion.
  • Cyclophosphamide — DRUG
    Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion.

Study Details

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.

Key Dates

Start date
Oct 26, 2024
Status verified
Mar 2026
Primary completion
Jan 13, 2029
Completion
Dec 13, 2033

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Participants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. The lymphodepletion regimen includes cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) administered over 3 days (Days -5, -4, -3). The standard "3+3" design will be used to guide dose escalation/de-escalation decisions based on the cumulative number of patients who experience a dose limiting toxicity (DLT) at the current dose. The first cohort of 3 patients will be treated at dose level 1. The target maximum doses infused at each dose level is: Dose Level 1: 1x10\^5 cells/kg Dose Level 2: 3x10\^5 cells/kg Dose Level 3: 1x10\^6 cells/kg Dose Level 4: 3x10\^6 cells/kg Dose Level 5: 1x10\^6 cells/kg
  • Experimental: Dose Expansion
    Participants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m\^2) and cyclophosphamide (500 mg/m\^2) prior to study day 0. Participants will then receive MSGV1-PSCA-8T28Z at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of MSGV1-PSCA-8T28Z [ Time Frame: Up to 30 days post transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Gillian Zankel
[email protected]
813-745-0876
Jingsong Zhang, MD, PhD (PRINCIPAL_INVESTIGATOR)
Juskaran Chadha, PhD (SUB_INVESTIGATOR)
Jad Chahoud, MD (SUB_INVESTIGATOR)
Monica Chatwal, MD (SUB_INVESTIGATOR)
Rohit Jain, MD (SUB_INVESTIGATOR)
Daniel Abate-Daga, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Moffitt Cancer Center· Tampa, FL

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