T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01946373|
Recruitment Status : Recruiting
First Posted : September 19, 2013
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Cyclophosphamide Drug: Fludarabine Biological: T cells Biological: Interleukin-2 Biological: Dendritic cell vaccine||Phase 1|
The MAT02 clinical trial is a phase 1 clinical trial with the objective to assess the safety, feasibility and immunological efficacy of the combined application of two immunological treatment modalities in patients with metastatic melanoma:
- Cohort A: After a non-myeloablative conditioning regimen, 5 patients will receive one bulk infusion of T cells. T cells will be expanded ex vivo from autologous tumor infiltrating lymphocytes (TIL). In vivo persistence of the infused cells will be supported by administration of IL-2, a T cell survival factor.
- Cohort B: This adoptive cell transfer (ACT) step will in additional 10 patients be followed by a vaccination with autologous, in vitro-generated, dendritic cells (DC), loaded with autologous tumor lysate and a synthetically produced peptide derived from the tumor associated antigen NY-ESO 1.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate Safety, Feasibility and Immunologic Response of Adoptive T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Metastatic Melanoma|
|Actual Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Chemotherapy + T cells + IL-2
Cyclophosphamide 60 mg/kg/d by vein (IV) daily for 2 days followed by fludarabine 25 mg/m^2 IV daily for 5 days before T cell infusion. The day after chemotherapy up to 5 x 10^10 T cells IV infusion. Interleukin-2 90 minutes after T cell infusion at a dose of 100,000 IU/kg as IV bolus over 15 minute period every 8-hours for up to 14 doses.
Biological: T cells
Experimental: Chemotherapy + T cells + IL-2 + DCV
Cyclophosphamide 60 mg/kg/d by vein (IV) daily for 2 days followed by fludarabine 25 mg/m^2 IV daily for 5 days before T cell infusion. The day after chemotherapy up to 5 x 10^10 T cells IV infusion. Interleukin-2 90 minutes after T cell infusion at a dose of 100,000 IU/kg as IV bolus over 15 minute period every 8-hours for up to 14 doses. After completion of the IL-2 treatment 3-5 doses of weekly intradermal vaccinations with up to 1.5 x 10^7 Dendritic cells pulsed with autologous tumor lysate and NY-ESO-1 peptide.
Biological: T cells
Biological: Dendritic cell vaccine
- Safety of the T cell therapy, with and without dendritic cell vaccine, as evaluated according to the NCI CTCAE scale version 4.0 [ Time Frame: 30 days ]
- Time to disease progression assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946373
|Contact: Maria Wolodarski, MDemail@example.com|
|Contact: Rolf Kiessling, MD, PhDfirstname.lastname@example.org|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, SE-171 76|
|Contact: Maria Wolodarski, MD +46851770000 email@example.com|
|Principal Investigator: Maria Wolodarski, MD|
|Principal Investigator:||Maria Wolodarski, MD||Karolinska University Hospital|