Center for Immunotherapy Clinical Research Trials

Cellular Therapy

A Phase I/IIa, Open Label, Clinical Trial Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs Specific for NY-ESO-l/LAGE-l in Patients with Recurrent or Treatment Refractory Ovarian Cancer

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: I 230612
Target Accrual: 6-10
Condition: Ovarian Cancer, NY-ESO-1+, HLA-A2.1+
Phase: I/IIa
ClinicalTrials.gov: NCT01567891
Status: Active
Intervention: Engineered TCR cells


A Phase l/lla Study of TGFβ Blockade in TCR-Engineered T-Cell Cancer Immunotherapy in Patients with Advanced Malignancies

Investigator: Richard Koya, MD, PhD
RPCI Study: I 258514
Target Accrual: 24
Condition: Solid Tumors, NY-ESO-1+, HLA-A2.1+
Phase: I/IIa
ClinicalTrials.gov: Pending
Status: Pending
Intervention: Engineered TCR cells


A Phase 1-2 Dose Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells after Partially Mismatched, Related T Cell-Depleted HSCT

Investigator: George Chen, MD
RPCI Study: PH 251514
Target Accrual: 3
Condition: ALL, AML, Lymphoma
Phase: I
ClinicalTrials.gov: NCT01744223
Status: Pending
Intervention: BPX-501, AP1903, Stem Cell Transplant


A Phase I, Open Label Study Evaluating the Safety and Efficacy of Adoptive Transfer of Autologous NY-ESO-1 CD4-TCR Engineered Hematopoietic Stem Cells in combination with NY-ESO-1 CD8-TCR Engineered T cells after a Nonmyeloablative Conditioning Regimen and Low Dose IL-2 in Patients with Recurrent or Treatment Refractory Ovarian Cancer

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: Pending
Target Accrual: 12
Condition: Ovarian Cancer, NY-ESO-1+, HLA-A2.1+, HLA-DP4+ or HLA-DR1+
Phase: I
ClinicalTrials.gov: Pending
Status: Pending
Intervention: Engineered TCR cells


Immunomodulatory

A Phase l/lla Study of TGFβ Blockade in TCR-Engineered T-Cell Cancer Immunotherapy in Patients with Advanced Malignancies

Investigator: Richard Koya, MD, PhD
RPCI Study: I 258514
Target Accrual: 24
Condition: Solid Tumors, NY-ESO-1+, HLA-A2.1+
Phase: I/IIa
ClinicalTrials.gov: Pending
Status: Pending
Intervention: Engineered TCR cells


A Phase I, Open Label Study Evaluating the Safety and Efficacy of Adoptive Transfer of Autologous NY-ESO-1 CD4-TCR Engineered Hematopoietic Stem Cells in combination with NY-ESO-1 CD8-TCR Engineered T cells after a Nonmyeloablative Conditioning Regimen and Low Dose IL-2 in Patients with Recurrent or Treatment Refractory Ovarian Cancer

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: Pending
Target Accrual: 12
Condition: Ovarian Cancer, NY-ESO-1+, HLA-A2.1+, HLA-DP4+ or HLA-DR1+
Phase: I
ClinicalTrials.gov: Pending
Status: Pending
Intervention: Engineered TCR cells


A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients with Newly Diagnosed Multiple Myeloma

Investigator: Sarah Holstein, MD, PhD
RPCI Study: PH 236713
Target Accrual: 10
Condition: Multiple Myeloma
Phase: III
ClinicalTrials.gov: NCT01850524
Status: Active
Intervention: MLN9708, Lenalildomide, Dexamethasone


A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age

Investigator: Sarah Holstein, MD, PhD
RPCI Study: I 210611
Target Accrual: 25
Condition: Multiple Myeloma
Phase: III
ClinicalTrials.gov: NCT01208662
Status: Active
Intervention: Bortezomib, Lenalidomide, Dexamethasone, Autologous Stem Cells


A Phase 1 Study to Evaluate the Safety and Tolerability of anti-PD-L1, MEDI4736, in combination with Tremelimumab in Subjects With Advanced Solid Tumors

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: I 243813
Target Accrual: 30
Condition: Solid Tumors
Phase: I
ClinicalTrials.gov: NCT01975831
Status: Active
Intervention: MEDI4736, Tremelimumab


A Phase I/II Evaluation of Olaparib in combination with Durvalumab and Tremelimumab in the Treatment of Recurrent Platinum Resistant or Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Patients Who Carry a Germline BRCA1 or BRCA2 Mutation

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: I 276015
Target Accrual: 30
Condition: Ovarian Cancer, BRCA mut, Plat res + Plat sens
Phase: I
ClinicalTrials.gov: Pending
Status: Pending
Intervention: Olaparib, Durvalumab (MEDI4736), Tremelimumab


A Phase 1/2 Dose Escalation Study With Expansion Cohorts to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: Pending
Target Accrual: 30
Condition: Ovarian Cancer
Phase: I/II
ClinicalTrials.gov: Pending
Status: Pending
Intervention: ONCOS-102, MEDI4736


A Phase 1/2 Trial of X4P-001 in Patients with Advanced Ovarian Cancer

Investigator: Emese Zsiros, MD, PhD, FACOG
RPCI Study: Pending
Target Accrual: 30
Condition: Ovarian Cancer
Phase: I/II
ClinicalTrials.gov: Pending
Status: Pending
Intervention: X4P-001


A Phase I/II Evaluation of Pembrolizumab with IV Bevacizumab and Oral Metronomic Cyclophosphamide for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Investigator: Emese Zsiros, MD, PhD, FACOG
RPCI Study: I 270715
Target Accrual: 40
Condition: Ovarian Cancer
Phase: I/II
ClinicalTrials.gov: Pending
Status: Pending
Intervention: Pembrolizumab, Bevacizumab, Cyclophosphamide


A Phase I/IIb Study of DEC205mAb-NY-ESO-1 Fusion Protein (CDX-1401) Given with Adjuvant Poly-ICLC in Combination with INCB024360 for Patients in Remission with Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: I 248613
Target Accrual: 50
Condition: Ovarian Cancer, NY-ESO-1+
Phase: I
ClinicalTrials.gov: NCT02166905
Status: Active
Intervention: CDX-1401, Poly-IC:LC, INCB024360


A Phase I Clinical Trial of mTOR Inhibition with Sirolimus for Enhancing Recombinant Full Length NY-ESO-1 Protein with Montanide and MIS416 Vaccine Induced Anti-Tumor Immunity in Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: I 277115
Target Accrual: 12
Condition: Ovarian Cancer, NY-ESO-1+
Phase: I
ClinicalTrials.gov: Pending
Status:  Pending
Intervention: rNY-ESO-1 protein, Montanide, MIS416, Poly-IC:LC, Sirolimus


A Randomized Phase 2 Trial of MPDL3280A, SGI-110, and DEC205mAb-NY-ESO-1 Vaccine (CDX-1401) in Recurrent Ovarian Cancer

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: Pending
Target Accrual: 60
Condition: Ovarian Cancer
Phase: II
ClinicalTrials.gov: Pending
Status:  Pending
Intervention: CDX-1401, Poly-IC:LC, SGI-110, MPDL4280A

Oncolytic Virotherapy

A Phase 1/2 Dose Escalation Study With Expansion Cohorts to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: Pending
Target Accrual: 30
Condition: Ovarian Cancer
Phase: I/II
ClinicalTrials.gov: Pending
Status: Pending
Intervention: ONCOS-102, MEDI4736

Antibody Therapy

A Phase I/II Evaluation of Pembrolizumab with IV Bevacizumab and Oral Metronomic Cyclophosphamide for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Investigator: Emese Zsiros, MD, PhD, FACOG
RPCI Study: I 270715
Target Accrual: 40
Condition: Ovarian Cancer
Phase: I/II
ClinicalTrials.gov: Pending
Status: Pending
Intervention: Pembrolizumab, Bevacizumab, Cyclophosphamide

Vaccine

A Phase I Trial of a Recombinant Human hspll0-gpl00 Chaperone Complex Vaccine for Advanced Stage IIIB/C or IV Melanoma

Investigator: John Kane III, MD, FACS
RPCI Study: I 215912
Target Accrual: 20
Condition: Melanoma
Phase: I
ClinicalTrials.gov: NCT01744171
Status: Active
Intervention:HSPll0-gpl00 vaccine


A Phase I/IIb Study of DEC205mAb-NY-ESO-1 Fusion Protein (CDX-1401) Given with Adjuvant Poly-ICLC in Combination with INCB024360 for Patients in Remission with Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: I 248613
Target Accrual: 50
Condition: Ovarian Cancer, NY-ESO-1+
Phase: I
ClinicalTrials.gov: NCT02166905
Status: Active
Intervention: CDX-1401, Poly-IC:LC, INCB024360


A Phase I Clinical Trial of mTOR Inhibition with Sirolimus for Enhancing Recombinant Full Length NY-ESO-1 Protein with Montanide and MIS416 Vaccine Induced Anti-Tumor Immunity in Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: I 277115
Target Accrual: 12
Condition: Ovarian Cancer, NY-ESO-1+
Phase: I
ClinicalTrials.gov: Pending
Status:  Pending
Intervention: rNY-ESO-1 protein, Montanide, MIS416, Poly-IC:LC, Sirolimus


A Randomized Phase 2 Trial of MPDL3280A, SGI-110, and DEC205mAb-NY-ESO-1 Vaccine (CDX-1401) in Recurrent Ovarian Cancer

Investigator: Kunle Odunsi, MD, PhD, FRCOG, FACOG
RPCI Study: Pending
Target Accrual: 60
Condition: Ovarian Cancer
Phase: II
ClinicalTrials.gov: Pending
Status:  Pending
Intervention: CDX-1401, Poly-IC:LC, SGI-110, MPDL4280A