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Study of Gene Modified Immune Cells in Patients With Advanced Melanoma
Phase 2 trial testing F5 TCR transgenic cells and MART-1 peptide pulsed dendritic cells in Metastatic Melanoma in 14 participants. Completed in 30 May 2019.
| Lead sponsor | Jonsson Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 13 October 2009 |
| Primary completion | 30 May 2019 |
| Estimated completion | 30 May 2019 |
| Sites | 1 location across United States |
Jonsson Comprehensive Cancer Center — full company profile →
18 and older, any sex, with Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| F5 TCR Transgenic Cells | 0 |
Overall survival is measured until the patient passes away
| Group | Value | 95% CI |
|---|---|---|
| F5 TCR Transgenic Cells | 14 | |
| F5 TCR Transgenic Cells | 0 |
Time frame: 3 months and 1 week. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | F5 TCR Transgenic Cells |
|---|---|---|
| Anemia | Vascular disorders | — |
| Hypotension | Cardiac disorders | — |
| Renal Insufficiency | Renal and urinary disorders | — |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | — |
| Cardiopulmonary arrest | Cardiac disorders | — |
| Deep Vein Thrombosis left subclavian | Cardiac disorders | — |
| Pancytopenia | Cardiac disorders | — |
| Rapid Drop in Hemoglobin level | Cardiac disorders | — |
| Respiratory Acidosis | Respiratory, thoracic and mediastinal disorders | — |
| Seizures | Nervous system disorders | — |
| Supraventricular tachycardia | Cardiac disorders | — |
| Reaction | System | F5 TCR Transgenic Cells |
|---|---|---|
| Anemia | Cardiac disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Fever | Nervous system disorders | — |
| Rash | Musculoskeletal and connective tissue disorders | — |
| Urinary Tract Infection | Renal and urinary disorders | — |
| Hyponatremia | Vascular disorders | — |
| Neutropenia | Cardiac disorders | — |
| Rigors | Nervous system disorders | — |
| Hypokalemia | Vascular disorders | — |
| Nausea | Nervous system disorders | — |
| Hypoalbuminemia | Skin and subcutaneous tissue disorders | — |
| Hypocalcemia | Vascular disorders | — |
| Chills | Nervous system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Hyperbilirubinemia | Endocrine disorders | — |
| Hyperglycemia | Endocrine disorders | — |
| Lymphopenia | Cardiac disorders | — |
| Fatigue | Respiratory, thoracic and mediastinal disorders | — |
| Hypomagnesemia | Vascular disorders | — |
| Hypotension | Vascular disorders | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Alkaline Phosphate Level elevated | Cardiac disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Coughs | Respiratory, thoracic and mediastinal disorders | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — |
| Edema-limbs lower | Vascular disorders | — |
| Hemorrhoids | Vascular disorders | — |
| Hypernatremia | Vascular disorders | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Shortness of breathe | Respiratory, thoracic and mediastinal disorders | — |
| Uveitis | Musculoskeletal and connective tissue disorders | — |
| Tachypenic | Cardiac disorders | — |
| Insomnia | Nervous system disorders | — |
| Confusion | Nervous system disorders | — |
| Elevated aspartate transaminase | Vascular disorders | — |
| Hiccups | Respiratory, thoracic and mediastinal disorders | — |
| Hyphosphatemia | Vascular disorders | — |
| Macular rash | Musculoskeletal and connective tissue disorders | — |
| Mood alteration: Anxiety | Nervous system disorders | — |
| Pain - Headache | Nervous system disorders | — |
Most-reported serious reactions: Anemia, Hypotension, Renal Insufficiency, Respiratory distress, Cardiopulmonary arrest, Deep Vein Thrombosis left subclavian, Pancytopenia, Rapid Drop in Hemoglobin level.
Data from ClinicalTrials.gov NCT00910650 adverse events section.
The purpose of this phase 2 study is to find the best way to give this new experimental regimen and determine if it can treat metastatic melanoma in humans. In this phase 2 study, the experimental products are given initially to a group of 8 people. If safe and found to have significant anti-tumor activity, it will be given to up to 14 other people, for a total of 22 people in this study. Physicians watch subjects carefully for any harmful side effects. Although the experimental regimen has been well tested in laboratory and animal studies, and a similar regimen has been given to a group of patients at the National Cancer Institute in Bethesda, MD, the side effects in people cannot be completely known ahead of time. This protocol is offered only to people whose condition cannot be helped by other known treatments. The study procedures will start with the collection of white blood cells through apheresis (a procedure in which blood is drawn from a patient and separated into its components, some of which are retained, such as white blood cells, and the remainder returned by transfusion to the patient). Subjects will be asked to undergo two aphereses, one to make the gene-modified MART-1 TCR CTLs (cytolytic T lymphocyte) and the dendritic cell vaccines, and a second one after the subject receives the gene modified cells to later study them in the blood. On the day of the first apheresis, subjects will be admitted to the hospital and will receive chemotherapy over the next five days which decreases the risk of rejection of the transferred cells by the subject's immune system and facilitates their expansion and attack of the melanoma lesions. During this time, the gene-modified MART-1 TCR CTLs and the dendritic cells will be manufactured in the laboratory from the apheresis product and will be extensively tested to assure that they express the appropriate TCR and that they do not contain any contaminating bacteria or virus. Then the gene-modified MART-1 TCR CTLs will be given back to the subject through a vein in the arm. It will be followed by vaccination with the dendritic cells under the skin. During the next fourteen days, subjects will also receive interleukin 2 (IL-2), which is a standard treatment for patients with metastatic melanoma. During the next 2 to 3 weeks, subjects will stay in the hospital until the study investigators determine that the subject has fully recovered from all of the procedures, and it is safe for the subject to go home. Chemotherapy frequently causes a decrease in the platelet or red blood cells, and therefore subjects may require platelet and/or red blood cell transfusions.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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