Clinical trials: Monoclonal Antibody
Crohn's Disease, Ulcerative Colitis
Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease
Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications.
- Conditions
- Crohn's Disease, Ulcerative Colitis, Healthy Controls
- Trial name
- NCT03397108
- Testing
- The IBD group was divided into 2 subgroups: with or without anti-TNF antibody use
- Where
- 2 sites in Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Non-small Cell Lung Cancer
Treatment of Non-small Cell Lung Cancer With PD-1 Monoclonal Antibody Combined With Donafenib Toluene Sulfonate
To assess the safety and efficacy of third-line and above therapy of patients with local advanced or metastatic non-small cell lung cancer (NSCLC) with combined treatment with launched recombinant humanized anti-PD-1 monoclonal…
- Trial name
- NCT04059874
- Testing
- donafenib tablets
- Where
- China
- Volunteers
- 20 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Prostate Cancer
A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC
A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab
- Trial name
- NCT06826768
- Testing
- REGN5678, Cemiplimab
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Head and Neck Cancer
Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in…
- Trial name
- NCT05287113
- Testing
- Retifanlimab, INCAGN02385, INCAGN02390
- Where
- 91 sites in United States, Belgium and 12 more
- Volunteers
- 176 people
- Sponsor
- Incyte Biosciences International Sàrl
Brain and Central Nervous System Tumors, Metastatic Cancer
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors.
- Conditions
- Brain and Central Nervous System Tumors, Metastatic Cancer, Neuroblastoma
- Trial name
- NCT00003461
- Testing
- surgical procedure, astatine At 211 monoclonal antibody 81C6
- Where
- United States
- Sponsor
- Duke University
Rectal Cancer
Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study
The objective is to evaluate whether the neoadjuvant combination of tislelizumab (a PD-1 inhibitor) with interleukin-2 (IL-2) chemotherapy can significantly increase the Objective Response Rate (ORR) and the Pathological Complete…
- Trial name
- NCT06884670
- Testing
- Interleukin-2, Radiotherapy, Tislelizumab
- Where
- 4 sites in China
- Volunteers
- 130 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Migraine
BIOmarkers of MIGraine: a Proof of Concept Study Based on the Stratification of Responders to CGRP Monoclonal Antibodies
Migraine is the 2nd most disabling neurological disease. It affects 14.7% of the population (children and adults) of whom 80% are female. In the European Union, the total annual cost of migraine is of 111 billion euros.
- Trial name
- BIOMIGA (NCT04503083)
- Where
- 3 sites in Germany, Italy and 1 more
- Volunteers
- 243 people, healthy volunteers welcome
- Sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
HTLV-I Infection, T Cell Leukemia
Anti-Tac for Treatment of Leukemia
The purpose of the study was to determine: (1) the toxicity and maximum tolerated dose (MTD) of humanized anti-Tac (daclizumab), (Zenapax(Registered Trademark)) in patients with adult T-cell leukemia/lymphoma (ATL); (2) to define…
- Trial name
- NCT00001941
- Testing
- daclizumab
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- National Cancer Institute (NCI)
Cutaneous T Cell Lymphoma (CTCL), Mycosis Fungoides
A Phase 1, Multicenter, Open-label, Prospective, First-in-human Dose-escalation Clinical Trial of Domain Therapeutics' Anti-CCR8 Monoclonal Antibody (DT-7012) in Patients With Relapsed or Refractory Cutaneous T-cell Lymphomas (CTCL)
Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of lymphomas characterized by a primary involvement of the skin. Among them, mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes.
- Conditions
- Cutaneous T Cell Lymphoma (CTCL), Mycosis Fungoides, Sezary Syndrome
- Trial name
- CITY (NCT07213882)
- Testing
- DT-7012
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
COVID 19
B Cell Responses in COVID-19
In this study, we will develop techniques to optimize the in vitro production of human monoclonal antibodies.
- Trial name
- NCT06891170
- Where
- Italy
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Melanoma
Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma
The main goal of this study is to test if it is safe and effective to give CDX-3379 together to treat advanced melanoma in patients with the NRAS mutation and BRAF/NRAS wildtype.
- Trial name
- NCT03580382
- Testing
- Trametinib daily Until PD, CDX-3379 (ERBB3 antibody)
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- NYU Langone Health
Gynecological Cancer, Immunotherapy
Detection of Circulating Therapeutic Monoclonal Antibodies in Biological Samples of Gynecological Cancer Patients.
Quantification of anti PD-1 mAbs in cancer patients is extremely important to monitor pharmacokinetics and effectiveness of immunotherapy.
- Trial name
- IMMUNO_ASSAY (NCT06797479)
- Testing
- Blood samples for the analysis of sildenafil in plasma
- Volunteers
- 12 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Covid19
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
No therapeutic agent is currently approved for the treatment of SARSCoV-2 infection. More importantly, no intervention is currently available to mitigate the progression of disease from mid/moderate to serve particularly in high…
- Trial name
- NCT04840459
- Testing
- BAMLANIVIMAB, CASIRIVIMAB, IMDEVIMAB
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Sohail Rao
Plasma Cell Myeloma
Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation
Primary Objectives: VCDI cohort: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone…
- Trial name
- NCT02513186
- Testing
- lenalidomide, bortezomib, cyclophosphamide
- Where
- 12 sites in France, Germany and 2 more
- Volunteers
- 90 people
- Sponsor
- Sanofi
Kidney Failure, Chronic, End-Stage Renal Disease
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant…
- Conditions
- Kidney Failure, Chronic, End-Stage Renal Disease, Transplant Glomerulopathy, Transplant;Failure,Kidney
- Trial name
- NCT03380962
- Testing
- Clazakizumab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanley Jordan, MD
Healthy
A Study to Evaluate Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Multiple Doses of VIS954
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of VIS954 compared with placebo in healthy adult participants.
- Trial name
- NCT06937593
- Testing
- VIS954
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Malignant Ascites
The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites
1. More than half of peritoneal metastases are from digestive tract. Peritoneal metastasis has poor prognosis, poor treatment response and limited means. 2.
- Trial name
- NCT06433869
- Testing
- serplulimab, Bevacizumab, rmhTNF-NC
- Where
- 3 sites in China
- Volunteers
- 60 people
- Sponsor
- Sun Yat-sen University
Glioblastoma Multiforme, High-grade Astrocytoma Not Otherwise Specified (NOS)
Phase I Study of APX005M in Pediatric Central Nervous System Tumors
This phase I trial studies the side effects and best dose of APX005M in treating younger patients with primary malignant central nervous system tumor that is growing, spreading, or getting worse (progressive), or newly diagnosed…
- Conditions
- Glioblastoma Multiforme, High-grade Astrocytoma Not Otherwise Specified (NOS), CNS Primary Tumor, Not Otherwise Specified (NOS), Ependymoma, Not Otherwise Specified (NOS)
- Trial name
- NCT03389802
- Testing
- APX005M treatment for recurrent or refractory primary malignant CNS tumor patients, APX005M treatment for newly diagnosed DIPG patients
- Where
- 11 sites in United States
- Volunteers
- 32 people
- Sponsor
- Pediatric Brain Tumor Consortium
Herpes Genitalis
Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection
This is a randomized, double-blind, double-dummy study of single dose HDIT101 versus Standard of Care Valaciclovir. HSV-2-positive patients with at least 4 anogenital herpes lesions in the last 12 months (or at least 2 herpes…
- Trial name
- MATCH-2 (NCT04165122)
- Testing
- HDIT101, Valaciclovir
- Where
- 8 sites in Germany
- Volunteers
- 122 people
- Sponsor
- Heidelberg ImmunoTherapeutics GmbH
Cervical Cancer
Study of GLS-010 Injection in Patients With Recurrent or Metastatic Cervical Cancer
Patients with recurrent or metastatic cervical cancer，and will be treated with GLS-010.
- Trial name
- CC (NCT03972722)
- Testing
- GLS-010
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Guangzhou Gloria Biosciences Co., Ltd.
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