Table 2.
Clinical trials evaluating the role of TH Cells in response to immunotherapies.
| ClinicalTrials.gov Identifier | Intervention | Target patients | Immune Outcome measure | Primary endpoint |
|---|---|---|---|---|
|
NCT03946358 Phase II |
Atezolizumab (anti PD-L1) and UCPVax (vaccine), Blood sample collection, Tumor biopsies, CT scan | Squamous Cell Carcinoma of the Head and Neck Anal Canal Cancer Cervical Cancer |
Objective response rate at 4 months | |
|
NCT03904537 Phase I/II |
anti-PD-1 antibody-activated TILs | Colorectal Cancer Stage III | CD3+, CD8+, CD4+ or CD56+ T cells | 6 months |
| NCT03844763 Phase I/II |
Avelumab (anti PD-L1), Radiation, and CTX (cyclophosphamide) | Head and Neck Cancer | Objective response rate (2-4 months) | |
| NCT03734692 Phase I/II |
Cisplatin, Pembrolizumab, Rintatolimod | Ovarian Cancer Recurrent | Pre-and post-treatment CD3+, CD4 Tbet+, CD8+, NK cells and granzyme B | 13 weeks |
|
NCT03698461 Phase II |
Atezolizumab, Bevacizumab, Oxaliplatin, Levoleucovorin, 5-fluorouracil | Colorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal Neoplasms | CD3, CD4, CD8 T cells, PD-L1, PD-1, CD45RO, FOXP3, CD68, Granzyme B | End of treatment |
|
NCT03410732 Phase II |
activated DCs, radical surgery only | Gastric Cancer | CD4/CD8 T cell percentage change | Progression free survival (3 years) |
|
NCT03067155 Phase II |
CMV-specific T cells, Standard anti-viral therapy | Hematological Malignancies CMV Infection |
1 year | |
|
NCT02818426 Phase I/II |
UCPVax (peptide vaccine) | Metastatic Non-small Cell Lung Cancer | 57 days (phase I) 73 days (phase II) |
|
| NCT02957968 Phase II |
Doxorubicin, Cyclophosphamide, Paclitaxel, Carboplatin, Decitabine, Pembrolizumab | Breast Adenocarcinoma Estrogen Receptor- Negative Breast Cancer Estrogen Receptor-positive Breast Cancer HER2/Neu Negative Invasive Breast Carcinoma Progesterone Receptor Negative Progesterone Receptor Positive Tumor Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Triple-negative Breast Carcinoma |
TIL %, CD3, CD4, CD8 T cells, Treg, MDSC, B cell, PD-1, PDL-1 | 29 days |
|
NCT01868490 Phase I/II |
cytokine induced killer cells | Cholangiocarcinoma | 6 weeks | |
|
NCT03384914 Phase II |
WOKVAC Vaccine, DC1 Vaccine | HER-2 Positive Breast Cancer | Immunogenicity (IFN-γ ELISPOT) | Up to 7 years |
|
NCT04552886 Phase I |
TH-1 Dendritic Cell Immunotherapy | Glioblastoma | 2 years | |
|
NCT04157127 Phase I |
Autologous DC vaccine | Pancreatic Adenocarcinoma Pancreatic Cancer | 6 weeks | |
| NCT02846103 | blood and tumor tissue samples (Immune monitoring) | Lung Cancer | UCP-specific Th1 response (IFN-γ ELISPOT) | 2 years |
|
NCT03387553 Phase I |
Dendritic Cell Vaccine (DC1), Neoadjuvant Chemotherapy, Curative Surgery |
HER2-positive Breast Cancer | HER2-specific Th1 response (IFN-γ ELISPOT) | 28 weeks |
|
NCT03977103 Phase II |
High dose irradiation conditioning + Treg/Tcon | Acute Myeloid Leukemia Acute Lymphoid Leukemia Myeloproliferative Disorders Lymphoma Multiple Myeloma Other Hematologic Malignant Neoplasms | 2 years | |
|
NCT03696030 Phase I |
Chimeric Antigen Receptor T-Cell Therapy | Metastatic Malignant Neoplasm in the Leptomeninges Breast Cancer HER2-positive |
Myeloid, B cells, T cells (including subtypes) in CSF, blood and TME, cytokines in CSF and blood | 21 days up to 15 years |
|
NCT04433221 Phase I/II |
Multiple sarcoma-specific CAR-T cells and sarcoma vaccines | Sarcoma Osteoid Sarcoma Ewing Sarcoma |
3 months | |
|
NCT01955460 Phase I |
Aldesleukin (Recombinant Human IL-2) Cyclophosphamide Fludarabine Phosphate NGFR-transduced Autologous T Lymphocytes TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes Laboratory Biomarker Analysis |
Metastatic Melanoma | Up to 5 years | |
| NCT03112590 Phase I/II |
Interferon-gamma (IFN-γ) Paclitaxel Trastuzumab Pertuzumab Post Therapy Surgery |
HER2-positive Breast Cancer | End of treatment |