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TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy

NCT04596033 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-07-15

No results posted yet for this study

Summary

TiTAN-1 is a first-in-human study of GEN-011, an experimental treatment being evaluated in adult patients with advanced cancer. GEN-011 is a T cell therapy made specific to each patient, using the patient's own circulating immune cells. First, Genocea confirms which cancer proteins are recognized already by each patient's T cells using ATLAS™. Then, immune cells that recognize these cancer proteins are multiplied many times (a process called PLANET™) to create a personalized GEN-011 cell therapy, which is given back to the patient in one or more intravenous (IV) infusions.

Conditions

Interventions

BIOLOGICAL

GEN-011

Personalized neoantigen adoptive cell therapy (ACT)

DRUG

IL-2

Cytokine

DRUG

Fludarabine

Lymphodepletion drug

DRUG

Cyclophosphamide

Lymphodepletion drug

Sponsors & Collaborators

  • Genocea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Davis, MD · Genocea Biosciences, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2022-06-27
Completion
2022-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04596033 on ClinicalTrials.gov