A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)

NOT ENROLLING
Protocol # :
20-075
Conditions
Prostatic Neoplasms, Castration-Resistant
Neoplasms by Histologic Type
Neoplasms, Prostate
Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Disease
Salivary Gland Cancer
Salivary Gland Tumor
Adenoid Cystic Carcinoma
Salivary Duct Carcinoma
Mucoepidermoid Carcinoma
Acinic Cell Tumor
Phase
I
Disease Sites
Prostate
Principal Investigator
Wei, Xiao, Xiao
Site Research Nurses
Gammon, Marilyn
Lucia, Megan
Noyes, Sarah, M.
Valles, Betsy, J.
Weigel, Susan

Trial Description

An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous
CAR-T cells in patients with mCRPC and SGC.

Eligibility Requirements

Inclusion Criteria:

- Subjects ≥18 years of age

- Must have a confirmed diagnosis of mCRPC or SGC

- Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA
(≥1 ng/mL) (mCRPC subjects only)

- Must have progressed by PCWG3 and/or RECIST 1.1 (mCRPC subjects only)

- Must be willing to practice birth control from screening and for 2 years after the
last administration of P-PSMA-101

- Must have adequate vital organ function within pre-determined parameters

- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

- Has inadequate venous access and/or contraindications to leukapheresis

- Has an active second malignancy in addition to mCRPC or SGC, excluding low-risk
neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma

- Has a history of or active autoimmune disease

- Has a history of significant central nervous system (CNS) disease, such as stroke or
epilepsy

- Has an active systemic (viral, bacterial or fungal) infection

- Has received anti-cancer medications (excluding GnRH targeted therapies) within 2
weeks of the time of initiating conditioning chemotherapy

- Has received immunosuppressive medications (including anti-cancer medications) within
2 weeks of initiating leukapheresis and/or expected to require them while enrolled in
the study

- Has received systemic corticosteroid therapy within 2 weeks of either the required
leukapheresis or is expected to require it during the course of the study

- Has CNS metastases or symptomatic CNS involvement

- Has a history of significant ocular disease

- Has a history of significant liver disease or active liver disease

- Has liver metastases (<5 lesions and maximum diameter

- Has a history of or known predisposition to HLH or MAS

20-075