Transfer of Genetically Engineered Lymphocytes in Melanoma Patients
NCT ID: NCT01586403
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
14 participants
INTERVENTIONAL
2012-07-31
2028-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose 1
Subjects in cohort 1 will receive 2.5 x 106 TIL 1383I TCR transduced T cells per kg body weight
Dose 1
Subjects will receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. cohort 1 will receive 2.5 x 106 TIL 1383I TCR transduced T cells per kg body weight. Subject in cohort 1 will receive 2.5 x 10\^6 TIL 1383I TCR transduced T cells per kg body weight.
Dose 2
cohort 2 will receive 7.5 x 106 TIL 1383I TCR transduced T cells per kg body weight.
Dose 2
Subjects will receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 2 will receive 7.5 x 10\^6 TIL 1383I TCR transduced T cells per kg body weight.
Dose 3
Subjects in cohort 3 will receive 2.5 x 107 TIL 1383I TCR transduced T cells per kg body weight.
Dose 3
Subjects will receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 3 will receive 2.5 x 10\^7 TIL 1383I TCR transduced T cells per kg body weight.
Dose 4
Subjects will then receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 4 will receive 7.5 x 107 TIL 1383I TCR transduced T cells per kg body weight.
Dose 4
Subjects then receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 4 will receive 7.5 x 10\^7 TIL 1383I TCR transduced T cells per kg body weight.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dose 1
Subjects will receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. cohort 1 will receive 2.5 x 106 TIL 1383I TCR transduced T cells per kg body weight. Subject in cohort 1 will receive 2.5 x 10\^6 TIL 1383I TCR transduced T cells per kg body weight.
Dose 2
Subjects will receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 2 will receive 7.5 x 10\^6 TIL 1383I TCR transduced T cells per kg body weight.
Dose 3
Subjects will receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 3 will receive 2.5 x 10\^7 TIL 1383I TCR transduced T cells per kg body weight.
Dose 4
Subjects then receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 4 will receive 7.5 x 10\^7 TIL 1383I TCR transduced T cells per kg body weight.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must be 18 years of age or older.
* Patients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelines.
* Patients must have a performance status of 0 or 1 ECOG PS scale (see Appendix B).
* The ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time.
* Patients' melanoma must be positive for both tyrosinase and HLA-A2 per Loyola University Medical Center pathologic review from FNA/core/excisional biopsy of lesion.
* Cardiac ejection fraction \>50% as determined by screening echocardiogram.
* Patients that have undergone treatment with anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) antibody must have at least 3 months from last dose of CTLA-4 antibody before they can be enrolled into this study.
* The patients BRAF mutation status at position 600 must be known prior to enrollment. Patients with V600E mutations are eligible if they have failed Vemurafenib therapy or have been offered Vemurafenib therapy and refused.
* Patients treated with prior Interleukin-2 will be allowed to be in this study.
Exclusion Criteria
* ECOG performance status of 2 or greater.
* Patients with a history metastatic melanoma involving the brain will be excluded if they have active disease or have had active disease within the prior six months that was not controlled with surgery or radiotherapy.
* Patients taking steroids for disease control or pain management
* Patients must not be pregnant or nursing because of the potentially harmful effects of these agents on a developing fetus. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
* Patients whose BRAF V600E mutation status is unknown, have the BRAF V600E mutation and are responding to Vemurafenib therapy, or have the BRAF V600E mutation and have not been offered the option of receiving Vemurafenib therapy for the treatment of their melanoma.
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years.
* Patients that have undergone Tyrosinase immunotherapy.
* Patients that have undergone immunotherapy in combination with non-myeloablative chemotherapy.
* Any of the following abnormal laboratory values:
* Absolute neutrophil count less than 1.5 x 109/L
* Platelet count less than 100 x 109/L
* Serum bilirubin greater than 1.5 x upper limit of normal (ULN)
* Serum ALT, AST greater than 2.5 x ULN
* Serum ALP greater than 2 x ULN
* Serum Albumin less than 2.5 g/dL
* International Normalized Ratio (INR) greater than 1.5
* Serum creatinine calculated creatinine clearance by the method of Cockcroft and Gault (less than 50mL/min).
* Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics.
* Any severe or poorly controlled systemic disease (e.g., hypertension; clinically significant cardiovascular, pulmonary, or metabolic disease, disorders of wound-healing, ulcer or bone fracture).
* Patients who have received any chemotherapy or investigational treatment within 4 weeks of study start.
* Known infection with HIV, HBV, or HCV.
* Known hypersensitivity to any of the components of the study drugs.
* Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Loyola University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michael Nishimura
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Nishimura, PhD
Role: PRINCIPAL_INVESTIGATOR
Loyola University Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Loyola University Medical Center
Maywood, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.