Dose-escalating Trial With UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker
1. Safety and tolerability (Time Frame - DLT period (infusion period of TMpPSMA + 7 days or + 14 days in patients with with myelosuppression)): Incidence and intensity of adverse events graded according to CTCAE V5.0 with the exception of CRS and ICANS graded according to Lee et al. 2014 and Lee et al. 2019 respectively
2. Incidence of dose limiting toxicity (DLT) (Time Frame - DLT period (infusion period of TMpPSMA + 7 days or + 14 days in patients with with myelosuppression)): DLT is defined as any adverse event at least possible related to TMpPSMA and/or UniCAR02-T
3. Maximum tolerated dose (MTD) (Time Frame - DLT period (infusion period of TMpPSMA + 7 days or + 14 days in patients with with myelosuppression)): The dose for which the isotonic estimate of the DLT probability is closest to the target DLT probability of 0.2.
Secondary outcome:
1. Recommended phase 2 dose (RP2D) (Time Frame - DLT period (infusion period of TMpPSMA + 7 days or + 14 days in patients with with myelosuppression)): The RP2D will be determined based on MTD, all available efficacy data, and all available safety data, including information derived from additional treatment cycles.
2. Antitumor activity (Time Frame - DLT period (infusion period of TMpPSMA + 7 days or + 14 days in patients with with myelosuppression)): Antitumor activity of UniCAR02-T-pPSMA at any time point according to irRECIST (immune-related) Response Evaluation Criteria in Solid Tumors): Complete remission (CR) and partial remission (PR), Objective response rate (ORR), Disease control rate (DCR), Best response rate, Duration of response (DOR),Progression free survival (PFS)
3. Prostate specific antigen (PSA) response (Time Frame - DLT period (infusion period of TMpPSMA + 7 days or + 14 days in patients with with myelosuppression))
4. Overall Survival (OS) (Time Frame - Until fifteen years after last UniCAR02-T administration)
5. Influence on Circulating tumor cells (CTC) (Time Frame - Before start of lymphodepletion therapy until 6 resp. 12 months after start of last TMpPSMA application)
Cyclophosphamide (Non-IMP): Intravenous infusion for 3 days
Fludarabine (Non-IMP): Intravenous infusion for 3 days
UniCAR02-T-pPSMA: Intravenous Infusion for 21 days
UniCAR02-T (IMP): Intravenous infusion of single dose
Quelle: ClinicalTrials.gov
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