P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate… (NCT04249947) | Clinical Trial Compass
TerminatedPhase 1
P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
Stopped: Study closed
United States40 participantsStarted 2020-02-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…
What they're measuring
1
Assess the Safety of P-PSMA-101
Timeframe: Baseline through 15 years
2
Determine the maximum tolerated dose of P-PSMA-101