Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Alaunos Therapeutics
Study ID
NCT04006119
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ad-RTS-hIL-12 — BIOLOGICAL
    * intratumoral injection of Ad-RTS-hIL-12 * 2.0 x 10\^11 viral particles (vp) per injection
  • Veledimex — DRUG
    20mg/day 15 oral daily doses of veledimex
  • Cemiplimab-Rwlc — DRUG
    Infusion every 3 weeks (350mg)

Study Details

This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. Cemiplimab-rwlc (Libtayo) is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Libtayo (cemiplimab-rwlc) is currently FDA approved in the United States for metastatic cutaneous cell carcinoma (CSCC), but is not approved in glioblastoma. Cemiplimab-rwlc may help your immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in combination with cemiplimab-rwlc to enhance the IL-12 mediated effect observed to date. The main purpose of this study is to evaluate the safety and efficacy of a single tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with cemiplimab-rwlc.

Key Dates

Start date
Aug 1, 2019
Status verified
Mar 2025
Primary completion
Aug 5, 2021
Completion
Aug 5, 2021

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ad-RTS-hIL-12 + veledimex in combination with cemiplimab-rwlc
    Intratumoral Ad-RTS-hIL-12 and oral veledimex (activator ligand, 20mg) given in combination with cemiplimab-rwlc via infusion.

Primary Outcome Measure

Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma. [ Time Frame: 2.0 yrs ]

Locations (7)

FacilityCityStateZIPSite coordinators
Cedars SinaiLos AngelesCalifornia90048-
University of California - San FranciscoSan FranciscoCalifornia94158-
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207-
Northwestern Memorial HospitalChicagoIllinois60611-
Brigham and Women'sBostonMassachusetts02115-
JFK Medical CenterEdisonNew Jersey08820-
NYU Langone HealthNew YorkNew York10016-

Find similar trials in Los Angeles, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Cedars Sinai· Los Angeles, CAUniversity of California - San Francisco· San Francisco, CABaptist MD Anderson Cancer Center· Jacksonville, FLNorthwestern Memorial Hospital· Chicago, ILBrigham and Women's· Boston, MAJFK Medical Center· Edison, NJ

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