SNPMiner Trials (Home Page)
Report for Clinical Trial NCT01586403
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
This is a phase one trial to determine if genetically engineered lymphocytes can be safely
delivered to patients with metastatic melanoma.
Name: Dose 1
Description: 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.
Type: Biological
Name: Dose 2
Description: 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.
Type: Biological
Name: Dose 3
Description: 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.
Type: Biological
Name: Dose 4
Description: 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.
Type: Biological
Primary Outcomes
Description: Establish the recommended phase two dose of autologous T cell receptor transduced T cells when administered with low dose IL-2 to stage IV melanoma patients
Measure: Find dose of autologous T cell receptor
Time: 4 weeks
Purpose: Treatment
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
SNPs
1 V600E
Patients with V600E mutations are eligible if they have failed Vemurafenib therapy or
have been offered Vemurafenib therapy and refused. --- V600E ---
- 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. --- V600E ---
- 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. --- V600E --- --- V600E ---
- 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. --- V600E --- --- V600E --- --- V600E ---