Clinical trial · Interventional
Vaccine Enriched, Autologous, Activated T-Cells Directed to Tumor in Patients With Relapsed/Refractory Melanoma
Phase I Study of Vaccine Enriched, Autologous, Activated T-Cells Redirected to the Tumor Marker GD2 in Patients With Relapsed/Refractory Melanoma
NCT02482532CI-TRIAL-00056333MARVSmALocompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The researchers will investigate if modified T-cells from a patients own system can be utilized to find and destroy metastatic melanoma tumor and thus improve patient outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tvs-CTL Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tvs-CTL Vaccine
- description
- Infusion of activated T-cells generated from a patient's own peripheral blood mononuclear cells.
- interventionNames
- Biological: tvs-CTL Vaccine
Primary outcomes (3)
- measure
- Measurement of infusion related adverse events to evaluate the safety of infused T-cells
- timeFrame
- 4 weeks
- description
- To evaluate the safety of autologous, receptor-transduced, activated T-cells, enriched for vaccine-specific cytotoxic T-lymphocytes (tvs-CTL)
- measure
- PCR measurement of retroviral construct to measure persistence of infused T-cells
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 66 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic, surgically unresectable melanoma or newly diagnosed melanoma of any stage, where the patient is unable to receive or complete standard therapy * Life expectancy of at least 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2 * Laboratory Values * absolute neutrophil count \> 500 microliters (mcL) * platelet \> 50,000 mcL * serum aspartate aminotransferase (AST) \< 5 x institutional upper limit of normal (IULN) * total bilirubin \< 3 x IULN * serum creatinine \< 3 x IULN * Pulse oximetry of \> 95% on room air. * Must have recovered from the toxic effects of all prior chemotherapy Exclusion Criteria: * Patients with rapidly progressive disease. * Patient is currently receiving any investigational drugs * Current cardiomegaly or bilateral pulmonary infiltrates on chest radiograph, pulmonary metastatic lesions are allowed * Patients must not have tumor in a location where enlargement could cause airway obstruction * Patient is pregnant or lactating * History of hypersensitivity reactions to murine protein-containing products. * Currently receiving immunosuppressive drugs such as corticosteroids (excluding topical treatment), tacrolimus or cyclosporin * Received any tumor vaccines within previous six weeks * Known hypersensitivity to rat monoclonal antibodies * History of severe allergic reaction to Hepatitis B vaccine, Polio vaccine or Tetanus, Diphtheria, Pertussis vaccine (DTP, Tdap, DT or Td). * Allergy to baker's yeast or other components of the vaccines. * History of allergy to the antibiotics Neomycin, Streptomycin or Polymyxin B * History of coma, long/multiple seizures within 7 days after DTP or Tdap, unless a cause other than the vaccine was indicated. * Melanoma involvement of the central nervous system * Chemotherapy given within the last 28 days * Presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
References
Publications (0)
Data not yet available
No reference posted for this study.