p-psma-101 car-t cells in the treatment of subjects with metastatic castration-resistant prostate cancer (mcrpc) and advanced salivary gland cancers (sgc)

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

Summary: 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.

this is an open label, multi-center phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of p-psma-101 to determine a recommended phase 2 dose (rp2d). additional participants will be treated with p-psma-101 at the determined rp2d. following consent, enrolled participants will undergo a leukapheresis procedure to obtain peripheral blood mononuclear cells (pbmcs) which will be sent to a manufacturing site to produce p-psma-101 car-t cells. the cells will then be returned to the investigational site and administered after a lymphodepleting chemotherapy regimen. rimiducid may be administered as indicated.

Eligibility criteria:
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 \</= 2.5 cm permitted) * has a history of or known predisposition to hlh or mas

Keywords: car-t cells metastatic castration-resistant prostate cancer (mcrpc)