Clinical trials: Biotherapy, open to volunteers
Ovary Neoplasm, Ovarian Cancer
Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian…
- Conditions
- Ovary Neoplasm, Ovarian Cancer, Epithelial Ovarian Cancer, Recurrent
- Trial name
- NCT06305299
- Testing
- iC9-CAR.B7-H3 T cells, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Atopic Dermatitis, Atopic Dermatitis, Unspecified
Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.
This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or…
- Conditions
- Atopic Dermatitis, Atopic Dermatitis, Unspecified, Dermatitis, Atopic
- Trial name
- NCT06899204
- Testing
- Abrocitinib
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Pfizer
Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), and the unclassified form referred to as indeterminate colitis, are most commonly diagnosed during adolescence and early adulthood.
- Trial name
- TDMpIBD (NCT06954311)
- Where
- 10 sites in Austria
- Volunteers
- 120 people
- Sponsor
- Medical University Innsbruck
Axial Spondyloarthrithis, Inflammatory Diseases
EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)
The goal of this randomised controlled trial study is to investigate whether exercise (brisk walking, equal to 13 on a rating of perceived exertion scale; somewhat hard) can be used as an adjuvant therapy for people living with…
- Conditions
- Axial Spondyloarthrithis, Inflammatory Diseases, Arthritis
- Trial name
- ExTASI-B (NCT06669702)
- Testing
- 12-week home based exercise, Routine care
- Where
- 2 sites in United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Loughborough University
Severe Asthma
Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma
In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with severe asthma.
- Trial name
- NCT07139899
- Testing
- Hyperpolarized Xenon 129
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Bastiaan Driehuys
Inflammatory Bowel Diseases, Crohn Disease
IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE
Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to…
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Trial name
- i-BANK (NCT03809728)
- Testing
- endoscopic biopsy, samples of the oral cavity, Samples of the resected specimen
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Central Hospital, Nancy, France
Inflammatory Bowel Diseases, Crohn Disease
Conventional vs Biologic Therapy in Pediatric IBD
This combined retrospective-prospective cohort study aims to evaluate the effectiveness, safety, and adverse events of conventional versus biologic therapy in children and adolescents with inflammatory bowel disease at Assiut…
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Trial name
- NCT07818473
- Volunteers
- 100 people
- Sponsor
- Assiut University
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Preoperative Stapokibart for Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Nasal Polyps
This is a single-center, randomized, double-blinded, placebo-controlled clinical trial in adults with moderate-to-severe chronic rhinosinusitis with nasal polyps (CRSwNP) who have no previous nasal surgery.
- Trial name
- NCT07616609
- Testing
- Stapokibart
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Beijing Tongren Hospital
Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Melanoma Neoplasms
Evaluation of Skin Tests in Biotherapy Allergies
Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases.
- Conditions
- Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Melanoma Neoplasms, Small Cell Bronchial Carcinomas, Bronchial Carcinoma
- Trial name
- ETCABIO (NCT06971848)
- Testing
- Drug skin tests (investigating hypersensitivity to a biotherapy)
- Where
- France
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Hospital, Angers
Ulcerative Colitis
LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
- Trial name
- NCT05327790
- Testing
- Lyophilized fecal microbiota (LFMT)
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of Alberta
Cancer
Safety and Tolerability of NCP-IL-22BP mRNA in Advanced Solid Tumors
This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor activity of NCP-IL-22BP mRNA, a non-cationic peptide-delivered mRNA encoding…
- Trial name
- NCT07562815
- Testing
- 25 μg NCP-IL-22BP mRNA, 50 μg NCP-IL-22BP mRNA, 100 μg NCP-IL-22BP mRNA
- Where
- China
- Volunteers
- 9 people
- Sponsor
- West China Hospital
Inflammatory Bowel Disease, Heart Rate Variability
Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD
This is a prospective, multicenter, observational cohort study, which plans to enroll patients with active IBD who are scheduled to initiate IFX or VDZ treatment between October 2025 and October 2027 at Xijing Hospital, Tang-du…
- Conditions
- Inflammatory Bowel Disease, Heart Rate Variability, Biologics, Prediction
- Trial name
- NCT07475052
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Xijing Hospital
Cancer
Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advanced Solid Tumors
This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor efficacy of PAN-NeoVax, an artificial intelligence (AI)-designed pan-cancer…
- Trial name
- NCT07560943
- Testing
- PAN-NeoVax (25 μg), PAN-NeoVax (50 μg), PAN-NeoVax (100 μg)
- Where
- 2 sites in China
- Volunteers
- 9 people
- Sponsor
- West China Hospital
Inflammatory Bowel Disease, Crohn Disease
High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease.
- Conditions
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency
- Trial name
- NCT04331639
- Testing
- vitamin D3
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Children's Hospital
Heart Failure With Preserved Ejection Fraction
EXercise and Activin Inhibition to Modulate InflammatioN Effects on Heart Failure and Cognition (EXAMINE-HFC)
The goal of this clinical trial is to learn if therapy with activin ligand-trap biological therapy (an investigational drug) combined with exercise training can improve exercise capacity and cognitive function in heart failure…
- Trial name
- EXAMINE-HFC (NCT07202000)
- Testing
- Activin ligand-trap biological therapy
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Massachusetts General Hospital
Brain Tumor, Brain Metastases
TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with Advanced Brain Cancer including Gliomas and…
- Conditions
- Brain Tumor, Brain Metastases, Brain Cancer, Glioma
- Trial name
- BAH2472 (NCT06640582)
- Testing
- Tumor Infiltrating Lymphocytes (TIL), Cyclophosphamide, Fludarabine
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Essen Biotech
Severe Asthma
Educational Needs of Patients With Severe Asthma on Targeted Immunotherapies
Severe asthma is a debilitating disease that affects every aspect of patients' lives: daily life, work, social life, family life, and marital life.
- Trial name
- BASIC (NCT07856407)
- Testing
- Initial assesment interwiew, Intake Interview with the Patient
- Volunteers
- 20 people
- Sponsor
- University Hospital, Angers
Asthma; Eosinophilic
REverse LuNg Airway and Vascular RemOdeling in Asthma ReMission (ReNORM)
In this program of research, the investigators aim to answer the question: In patients with asthma aged 18-80, how do the lung airways and vessels respond to biologic therapy and what role does age and asthma duration have in…
- Trial name
- ReNORM (NCT07174713)
- Testing
- Biologic Therapy
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Western University, Canada
Psoriasis Arthritis
A Study of Clinical and Immune Responses to Sequential Biologic Therapies in Psoriatic Arthritis
The goal of this observational study is to evaluate how well advanced therapies work in adults with psoriatic arthritis (PsA) who are starting a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) as…
- Trial name
- STRIDE-PsA (NCT07417995)
- Testing
- Biologic or targeted synthetic DMARD (b/tsDMARD)
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- Royal United Hospitals Bath NHS Foundation Trust
Axial Spondyloarthritis
Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies
The primary objective of the study is to study the change in SpA disease activity, according to ASAS20 definition (Anderson et al., 2001), after 8 weeks of VNS treatment versus placebo non-specific stimulation (control group).
- Trial name
- ESNV-SPA (NCT04286373)
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris