TerminatedPhase 1

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

Stopped: Business reasons

United States49 participantsStarted 2020-11-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consents to study procedures * Diagnosis of one of the following solid tumors: cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), renal cell carcinoma (RCC), small cell lung cancer (SCLC), cutaneous squamous cell carcinoma (CSCC), anal squamous cell carcinoma (ASCC), merkel cell carcinoma (MCC). * Received, been intolerant of, or been ineligible to receive standard of care treatment regimen. * Measurable disease per RECIST criteria * Life expectancy \> 6 months and ECOG status 0 or 1 * Capacity to tolerate lymphodepletion (SHD group only) and IL-2 therapy * Tumor tissue available * Willing to use contraceptives for 90 days after receiving GEN-011, and not currently pregnant. * Adequate blood, liver, kidney, and lung function * Sufficient stimulatory neoantigens identified in ATLAS Exclusion Criteria: * Receiving immunosuppressive medications * Serious ongoing viral, bacterial, or fungal infection * History of cardiac arrhythmias or significant heart block * History of leptomeningeal carcinomatosis * Active autoimmune disease * Portal vein thrombosis * Malignant disease other than those treated in this study * Receiving other investigational anti-cancer therapy * Prior stem cell or solid organ transplant * Primary immune deficiency disease * Significant ongoing toxicities from prior therapies * A history of allergic reaction to sulfur derivatives

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: 2 years after first GEN-011 infusion

Trial details

NCT IDNCT04596033

SponsorGenocea Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-27

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