Clinical trials: Early Phase 1
Air Trapping, Emphysema
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
The objective of this study is to provide a regional, mechanistic characterization of pulmonary ventilation changes following treatment with the Apreo BREATHE System, using hyperpolarized ¹²⁹Xe MRI, in BREATHE-3 participants.
- Conditions
- Air Trapping, Emphysema, Hyperinflation
- Trial name
- BREATHE-Xe (NCT07896902)
- Testing
- Hyperpolarized Xenon MRI, Apreo BREATHE Airway Scaffold
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Apreo Health, Inc.
Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy
TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed/Refractory primary small…
- Trial name
- NCT07246304
- Testing
- TC-D101 CAR-T
- Where
- China
- Volunteers
- 24 people
- Sponsor
- TCRCure Biopharma Ltd.
TCR-T Cells, Refractory Solid Tumors
KSX01-TCRT Injection Project in Solid Tumors
1) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.
- Conditions
- TCR-T Cells, Refractory Solid Tumors, Relapsed Solid Tumors
- Trial name
- NCT05811975
- Testing
- KSX01-TCRT injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- TCRx Therapeutics Co.Ltd
TCR-T Cells, Refractory Solid Tumors
KSH01-TCRT Solid Tumors
1) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.
- Conditions
- TCR-T Cells, Refractory Solid Tumors, Relapsed Solid Tumors
- Trial name
- KSH01-TCRT (NCT05539833)
- Testing
- KSH01 injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- TCRx Therapeutics Co.Ltd
Solid Tumor
KSH01-R02-101 Solid Tumors
1. . safety and tolerance 2. . objective response rate
- Trial name
- NCT05580796
- Testing
- KSH01 injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- TCRx Therapeutics Co.Ltd
Influenza
A Trial of RLX-2508-102 in Healthy Volunteers
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose and multiple dose of RLX-2508 in healthy participants across different ethnic backgrounds.
- Trial name
- NCT07873671
- Testing
- RLX-2508
- Where
- 3 sites in Australia
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Pancreatic Carcinoma
CEB-01 in Locally Resectable Pancreatic Cancer
The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent.
- Trial name
- NCT06538857
- Testing
- Standard surgery, CEB-01
- Where
- 4 sites in Spain
- Volunteers
- 39 people
- Sponsor
- CEBIOTEX
Metastatic Clear Cell Renal Cell Carcinoma
Imaging Study in Metastatic Clear Cell RCC.
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in Subjects with Metastatic Clear Cell Renal Cell Cancer (RCC).
- Trial name
- NCT07671417
- Testing
- RYZ512
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 10 people
- Sponsor
- RayzeBio, Inc.
Metastatic Urothelial Carcinoma, Breast Cancer
Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
- Conditions
- Metastatic Urothelial Carcinoma, Breast Cancer, TNBC - Triple-Negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT07671092
- Testing
- RYZ211/212
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 40 people
- Sponsor
- RayzeBio, Inc.
HIV Infections
Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients 1.
- Trial name
- HIVGP-BCG (NCT07182838)
- Testing
- HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
Transtibial Amputee, Transtibial Amputation
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.
- Trial name
- NCT07195461
- Testing
- Magnetic Bead Tracking System
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- MuscleMetrix, LLC
Gastric Cancer (GC), Colorectal Cancer
Safety and Efficacy of NK510 to Treat Gastric Cancer and Colorectal Cancer
This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and…
- Trial name
- NCT07166263
- Testing
- NK510
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Relapsed/Refractory Acute Myeloid Leukemia
Safety and Efficacy of NK520 to Treat Relapsed/Refractory Acute Myeloid Leukemia
This study will evaluate the safety and efficacy of NK520 in the treatment of relapsed/refractory acute myeloid leukemia. NK520 will be administered by intravenous injection.
- Trial name
- NCT06541444
- Testing
- NK520
- Where
- China
- Volunteers
- 2 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Refractory Systemic Lupus Erythematosus
NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.
- Trial name
- NCT07083349
- Testing
- NK510 : allogeneic genetic modified NK
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Solid Tumors, Metastatic Cancer
IL-15 Enhanced NK Cell Therapy for Solid Tumors
A single-arm, Phase 1 study evaluating safety, tolerability, and preliminary efficacy of IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.
- Trial name
- NCT07621471
- Testing
- IL-15 enhanced engineered NK cells
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Genovn Therapeutics (Suzhou) Co., Ltd.
Relapsed/Refractory Acute Myeloid Leukemia
Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia
This study will evaluate the safety and efficacy of NK520 in the treatment of pediatric relapsed/refractory acute myeloid leukemia. NK520 will be administered by intravenous injection.
- Trial name
- NCT06541405
- Testing
- NK520
- Where
- China
- Volunteers
- 2 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Hepatocellular Carcinoma (HCC), Ovarian Cancer
NK521 in the Treatment of Advanced Solid Tumors
Eligible subjects with advanced hepatocellular carcinoma and ovarian cancer will be divided into two treatment groups based on the volume of ascites.
- Conditions
- Hepatocellular Carcinoma (HCC), Ovarian Cancer, Malignant Ascites
- Trial name
- NCT07657416
- Testing
- NK521 Cell Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Lymphoma, B Cell Lymphoma
CD30 CAR-T in the Treatment of CD30 Positive Lymphoma
The is a prospective, open-label, dose-climbing multicenter clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。
- Conditions
- Lymphoma, B Cell Lymphoma, CD30+ Peripheral T-cell Lymphoma
- Trial name
- CAR-T，MTD (NCT07048353)
- Testing
- chimeric antigen receptor gene modified T cells
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shandong Qilu Cell Therapy Engineering Technology Co., Ltd
Atherosclerotic Cardiovascular Disease, Acute Coronary Syndromes
Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Followed by an Open-label Patient Cohort
The goal of this clinical trial is to learn if UDP-003 is safe in healthy human participants and patients, assess the pharmacokinetics (PK)/pharmacodynamics (PD) of UDP-003 in healthy human participants and patients and its…
- Trial name
- CTx-001 (NCT06813339)
- Testing
- UDP-003
- Where
- 3 sites in Australia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Cyclarity Therapeutics, Inc.
HER2 Gene Mutation, Advanced Solid Tumors
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.
- Trial name
- RAD202 (NCT06824155)
- Testing
- 177Lu-RAD202
- Where
- 5 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd