Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Prostatic Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma, Renal Cell

Kidney Neoplasms

Colonic Neoplasms

Carcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Adenocarcinoma

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Herbal and Botanical

Cyclophosphamide

Hormones

Vaccines

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Cola

Patients who meet all entry criteria will be administered 600 mg/m\^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).

Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)

Michael Silverman, MD

The purpose of this study is to evaluate the feasibility, safety, and tolerability of administering ZYC300 with Cyclophosphamide (Cytoxan).

This is an open-label study of ZYC300 in the treatment of advanced stage malignancy of the kidney in patients who have not had previous immune-based therapies or treatment of advanced stage malignancies (cancerous growths) of the ovary, breast, colon, or hormone-refractory prostate in patients who have failed at least one but no more than two prior regimens of chemotherapy. Patients who meet all entry criteria will be administered 600 mg/m\^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).

ZYC300 is a plasmid DNA formulated within biodegradable microencapsulated particles. This is the first time that ZYC300 and Cyclophosphamide will be given together. Cyclophosphamide is a chemotherapy drug approved by the FDA that has been used for many years in many different kinds of cancer. In this trial the study drug will be used to boost the immune system. Sometimes the immune system cannot fight infected or abnormal cells because of other cells called T reg cells. The T reg cells limit the immune systems attack on infected or abnormal cells. In this study, the hope is that Cyclophosphamide will inhibit the T regs cells so that the ZYC300 can work better to attack the cancer cells.

A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing

A Phase 1 Open-Label Study of the Safety and Feasibility of ZYC300 Administration With Cyclophosphamide Pre-Dosing

Eisai Inc.

Blood and Lymph Conditions

Immune System Diseases

Infections

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Stomach Neoplasms

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Epstein-Barr Virus Infections

Lymphoma, Large B-Cell, Diffuse

Hodgkin Disease

Virus Diseases

Lymphoma, B-Cell

Nasopharyngeal Carcinoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Stomach Diseases

Stomach Cancer

Lymphosarcoma

Peripheral T-cell Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Hodgkin Lymphoma

Analgesics

Anti-Infective Agents

Fludarabine

Fludarabine phosphate

Interleukin-2

Sulfamethazine

Analgesics, Non-Narcotic

Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISP-Cas9 system and EBV-CTL will be generated in the laboratory (PD-1 Knockout EBV-CTL).

Fludarabine at 30mg/m2 and Cyclophosphamide at 300mg/m2 single dose will be administered 3 days i.v. before cell infusion.

A total of 2 x 10\^7/kg PD-1 Knockout CTL will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third.

Interleukin-2 (IL-2) will be given daily( iv) since the first day of the cell infusion for 5 consecutive days, 4000,000 international unit（IU）/day . Patients will receive a total of four cycles of treatment.

To sustain the survival of infused T cells

Baorui Liu, MD

Shu Su, MD

Yang Yang, MD,PhD,MSCR

Jing Yan, MD

Yang Yang

This study will evaluate the safety of PD-1 knockout EBV-CTL cells in treating EBV (Epstein-Barr virus) positive advanced stage malignancies. Blood samples will also be collected for research purposes.

This is a study of CRISPR-Cas9 mediated PD-1 knockout-T cells from autologous origin. Patients are assigned to receive 4 circles of cell therapy. The safety and clinical response are evaluated. Biomarkers and immunological markers are also monitored.

PD-1 Knockout EBV-CTLs for Advanced Stage Epstein-Barr Virus (EBV) Associated Malignancies

A Phase I/II Trial of PD-1 Knockout EBV-CTLs for Advanced Stage EBV Associated Malignancies

MD, PhD, MSCR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing	NCT00381173	Breast Cancer Ovarian Cancer Prostate Cancer Colon Cancer Renal Cancer	Cyclophosphamid...	18 Years -	Eisai Inc.
PD-1 Knockout EBV-CTLs for Advanced Stage Epstein-Barr Virus (EBV) Associated Malignancies	NCT03044743	Stage IV Gastri... Stage IV Nasoph... T-Cell Lymphoma... Stage IV Adult ... Stage IV Diffus...	Fludarabine Cyclophosphamid... Interleukin-2	18 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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