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Protocol # 20-075

Status

Active, not recruiting

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.

Condition

  • 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

Interventions

  • P-PSMA-101 CAR-T cells
  • Rimiducid

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Assess the Safety of P-PSMA-101
  • Determine the maximum tolerated dose of P-PSMA-101
  • Assess the efficacy of P-PSMA-101 (ORR)

Enrollment

60

Study Start Date

February 28, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Poseida Therapeutics, Inc.

Source

Poseida Therapeutics, Inc.

Official title

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)

Clinicaltrials.gov Identifier

NCT04249947

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.