Clinical trial · Interventional
TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy
A Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reasons
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Squamous Cell Carcinoma | Anal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| GEN-011 | Biological | — | UNRESOLVED |
| IL-2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multiple Low Dose (MLD)
- description
- GEN-011 is administered by IV infusion at 4-week intervals, up to 5 doses maximum. Each dose is followed by IL-2 administration. MLD patients will not undergo lymphodepletion.
- interventionNames
- Biological: GEN-011
- Drug: IL-2
- type
- EXPERIMENTAL
- label
- Single High Dose (SHD)
- description
- GEN-011 is administered as a single IV infusion at the maximum available cell yield, after the patient completes a fludarabine/cyclophosphamide lymphodepletion regimen. The single GEN-011 dose is followed by IL-2 administration.
- interventionNames
- Biological: GEN-011
- Drug: IL-2
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available