MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian Fallopian Tube or Primary Peritoneal Cancer

  • STATUS
    Recruiting
  • End date
    Oct 12, 2037
  • participants needed
    18
  • sponsor
    University of Pennsylvania
Updated on 12 February 2021
cancer
fludarabine
cyclophosphamide
carcinoma
metastasis
neutrophil count
tumor cells
chemotherapy regimen
cancer chemotherapy
fallopian tube
cns metastases
peritoneal cancer
primary peritoneal carcinoma
peritoneal carcinoma

Summary

Phase I study to establish safety and feasibility of intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy

Description

This is a Phase I study evaluating the safety and feasibility of intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells in 4 cohorts with or without cyclophosphamide + fludarabine in a 3+3 dose escalation design.

The DLT observation period is 28 days post CAR T cell infusion. The Maximum Tolerated Dose (MTD) is defined as the dose at which 0 or 1 DLT occurs in 6 evaluable subjects tested within the dose range of this study.

Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy.

Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.

Cohort 3: (n=3 to 6 subjects): Single infusion of 1-3x108 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.

Cohort -1: (n= 3 to 6 subjects): Single Infusion of 1-3x106 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. Up to 6 subjects will be infused in Cohort -1 with 1 DLT/6 subjects to establish the MTD.

Details
Condition Ovarian disorder, Fallopian Tube Cancer, Ovarian Cancer, Ovarian Function, Primary Peritoneal Cancer, Primary Peritoneal Carcinoma, Recurrent Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, fallopian tube cancers, ovarian tumors
Treatment MOv19-BBz CAR T cells, Alpha Folate Receptor expression test
Clinical Study IdentifierNCT03585764
SponsorUniversity of Pennsylvania
Last Modified on12 February 2021

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