Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
TCR2 Therapeutics
Study ID
NCT03907852
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Cholangiocarcinoma
  • Cholangiocarcinoma Recurrent
  • High Grade Ovarian Serous Adenocarcinoma
  • Mesothelioma
  • Mesothelioma Peritoneum
  • Mesothelioma, Malignant
  • Mesothelioma; Pleura
  • Mesotheliomas Pleural
  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer Metastatic
  • Ovarian Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • gavo-cel — BIOLOGICAL
    gavo-cel
  • fludarabine — DRUG
    lymphodepletion chemotherapy
  • cyclophosphamide — DRUG
    lymphodepletion chemotherapy
  • Nivolumab — DRUG
    immuno-oncology agent
  • Ipilimumab — DRUG
    immuno-oncology agent

Study Details

Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex. This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.

Key Dates

Start date
Apr 15, 2019
Status verified
Aug 2025
Primary completion
Nov 19, 2024
Completion
Nov 2, 2028

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lymphodepletion followed by gavo-cel
    fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel
  • Experimental: Lymphodepletion followed by gavo-cel plus nivolumab
    fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel
  • Experimental: Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab
    fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel and ipilimumab 1mg/kg every 6 weeks starting on Day 42 post gavo-cel

Primary Outcome Measure

Phase 1- Primary Objective [ Time Frame: DLTs within 28 days post-treatment ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-
University of Miami Sylvester Cancer CenterMiamiFlorida33136-
University of Chicago Medical CenterChicagoIllinois60637-
National Cancer InstituteBethesdaMaryland20814-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke UniversityDurhamNorth Carolina27705-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
SCRI Oncology PartnersNashvilleTennessee37203-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in San Francisco, CA

By condition
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OncologyLung oncologyLung diseaseGynecologic oncologyWomen's health
By research site
University of California, San Francisco· San Francisco, CAUniversity of Miami Sylvester Cancer Center· Miami, FLUniversity of Chicago Medical Center· Chicago, ILNational Cancer Institute· Bethesda, MDColumbia University Medical Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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