Clinical trial · Interventional
Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma
A Pilot Study of the Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma
- 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)
RATIONALE: Cytotoxic T lymphocytes (CTL) are cells of the immune system that can fight infections and cancer. These CTL can be manipulated in the laboratory so that they can target an individual's cancer. PURPOSE: This early phase trial is studying the feasibility and side effects of intravenous infusions of CTL generated in the laboratory. To produce the CTL, the study participant's own immune cells are collected by a procedure called a leukapheresis. The cells then undergo laboratory processing for three weeks. Part of this processing includes mixing the patients immune cells with a new kind of cell that has some extra genes added to it. These extra genes are to "teach" the participant's own immune cells to become anti-tumor CTL that can attack the melanoma.
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 (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Drug | — | UNRESOLVED |
| Irradiation of cutaneous tumor lesion | Radiation | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
| Use of an artificial antigen presenting cell (aAPC) to generate CTL | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Different dose of CTL
- interventionNames
- Biological: therapeutic autologous lymphocytes
- Genetic: Use of an artificial antigen presenting cell (aAPC) to generate CTL
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Different dose of CTL
- interventionNames
- Biological: therapeutic autologous lymphocytes
- Genetic: Use of an artificial antigen presenting cell (aAPC) to generate CTL
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with metastatic melanoma: Either unresectable Stage III or any Stage IV * ECOG of 0 or 1 * HLA-A\*0201 haplotype * Baseline tumor biopsy MART1/Melan-A expression present (in \>10% of tumor cells) * Patient provides consent for all required biopsies * Adequate intravenous access for leukapheresis * Absolute lymphocyte count \>500/ul at least once within 30 days of leukapheresis * Life expectancy greater than 4 months in the opinion of the study clinician * Negative pregnancy test Exclusion Criteria: * Administration of systemic corticosteroids within 28 days of planned leukapheresis * Administration of cytotoxic chemotherapy or anti-tumor immunotherapy within 28 days of planned leukapheresis * Administration of radiotherapy within 28 days of planned leukapheresis with the exception of subjects accrued to Cohort 3 * Active autoimmunity requiring systemic immunosuppressive therapy * HIV infection * Previous enrollment on this protocol and infusion of MART1/Melan-A CTL
References
Publications (1)
- RESULTButler MO, Friedlander P, Milstein MI, Mooney MM, Metzler G, Murray AP, Tanaka M, Berezovskaya A, Imataki O, Drury L, Brennan L, Flavin M, Neuberg D, Stevenson K, Lawrence D, Hodi FS, Velazquez EF, Jaklitsch MT, Russell SE, Mihm M, Nadler LM, Hirano N. Establishment of antitumor memory in humans using in vitro-educated CD8+ T cells. Sci Transl Med. 2011 Apr 27;3(80):80ra34. doi: 10.1126/scitranslmed.3002207. PMID 21525398