NCT04596033

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

Terminated Phase 1 Last updated 15 July 2022

What this trial tests

Phase 1 trial testing GEN-011 in Melanoma in 49 participants. Terminated before completion.

Timeline

11 November 2020

Primary endpoint
27 June 2022

27 June 2022

Quick facts

Lead sponsor	Genocea Biosciences, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	11 November 2020
Primary completion	27 June 2022
Estimated completion	27 June 2022
Sites	8 locations across United States

Drugs / interventions tested

• GEN-011 — full drug profile →
• IL-2 — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Melanoma — all drugs for Melanoma →
• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
• Squamous Cell Carcinoma of Head and Neck — all drugs for Squamous Cell Carcinoma of Head and Neck →
• Urothelial Carcinoma — all drugs for Urothelial Carcinoma →

Sponsor

Genocea Biosciences, Inc. — full company profile →

Who can join

18 and older, any sex, with Melanoma or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoantigens: promising targets for cancer therapy.
   Xie N, Shen G, Gao W, Huang Z, et al · · 2023 · cited 713× · PMID 36604431 · DOI 10.1038/s41392-022-01270-x
2. Therapeutic Implications of Tumor Microenvironment in Lung Cancer: Focus on Immune Checkpoint Blockade.
   Genova C, Dellepiane C, Carrega P, Sommariva S, et al · · 2021 · cited 168× · PMID 35069581 · DOI 10.3389/fimmu.2021.799455
3. Targeting nucleotide metabolism: a promising approach to enhance cancer immunotherapy.
   Wu HL, Gong Y, Ji P, Xie YF, et al · · 2022 · cited 123× · PMID 35477416 · DOI 10.1186/s13045-022-01263-x
4. Tumor-Infiltrating Lymphocyte Therapy in Melanoma: Facts to the Future.
   Betof Warner A, Corrie PG, Hamid O. · · 2023 · cited 81× · PMID 36485001 · DOI 10.1158/1078-0432.ccr-22-1922
5. Trial watch: chemotherapy-induced immunogenic cell death in oncology.
   Sprooten J, Laureano RS, Vanmeerbeek I, Govaerts J, et al · · 2023 · cited 59× · PMID 37284695 · DOI 10.1080/2162402x.2023.2219591
6. Adoptive T Cell Therapy for Solid Tumors: Pathway to Personalized Standard of Care.
   Qin SS, Melucci AD, Chacon AC, Prieto PA. · · 2021 · cited 29× · PMID 33916369 · DOI 10.3390/cells10040808
7. Classic and new strategies for the treatment of advanced melanoma and non-melanoma skin cancer.
   Rubatto M, Sciamarrelli N, Borriello S, Pala V, et al · · 2022 · cited 20× · PMID 36844955 · DOI 10.3389/fmed.2022.959289
8. The Role of Neoantigens in Cancer Immunotherapy.
   Zhu Y, Liu J. · · 2021 · cited 17× · PMID 34513673 · DOI 10.3389/fonc.2021.682325