Clinical trials: Early Phase 1
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
B-cell Acute Lymphoblastic Leukemia
SNC116 Therapy for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
This study aims to evaluate the safety and pharmacokinetic profile of SNC116 in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia
- Trial name
- NCT07830238
- Testing
- SNC116
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.
Autoimmune Diseases
GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases
This study is a prospective single-arm open-label clinical trial, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune diseases.
- Trial name
- NCT07122076
- Testing
- GT719 Injection
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Grit Biotechnology
Healthy
A Phase 0, Open-Label, Crossover Microdose Pharmacokinetic Study of PRX-P4-003 in Healthy Volunteers
This is a Phase 0, open-label, crossover microdose pharmacokinetic study of PRX-P4-003 in healthy volunteers.
- Trial name
- NCT04638803
- Testing
- PRX-P4-003, (-)-FCF
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Praxis Bioresearch, LLC
Epilepsy (Treatment Refractory)
Translational Recording and Characterization of Epilepsy Signals Using Subgaleal EEG During Standard-of-care SEEG Monitoring
TRACE is a record-only study evaluating subgaleal EEG (sgEEG) recorded concurrently with standard-of-care stereoelectroencephalography (SEEG) in adults with drug-resistant epilepsy undergoing inpatient epilepsy monitoring.
- Trial name
- TRCE (NCT07821697)
- Testing
- EEG Record only
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Adraxe Corp.
HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer
A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer
This Window of Opportunity clinical trial will examine the immunologic effects of the study agent HB-201 in the head and neck or cervical cancer, when administered by IV route.
- Trial name
- NCT04630353
- Testing
- HB-201 IV
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Relapsed/Refractory Acute Myeloid Leukemia (AML)
A Clinical Study to Investigate the Safety and Efficacy of Off-the-Shelf iNKT Cell Injection Targeting CD33/CD70 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
This is a single-arm, open-label, dose-escalation, prospective exploratory clinical study intended to evaluate the safety, efficacy and cellular pharmacokinetics of GT737 cells in adult patients with relapsed/refractory acute…
- Trial name
- NCT07676006
- Testing
- GT737 Injection
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Grit Biotechnology
Oral Mucositis, Stem Cell Transplant Complications
Study of a New Medical Device for Oral Mucositis
This is a single-center randomized controlled trial of a new medical device (Bocaliner™) that has been designed to improve the treatment of chemotherapy-induced oral mucositis in patients undergoing cancer treatment.
- Trial name
- MDOM (NCT05104268)
- Testing
- Bocaliner
- Where
- Armenia
- Sponsor
- E2Bio Life Sciences, LLC
IgA Nephropathy (IgAN), Membranous Nephropathy
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.
- Conditions
- IgA Nephropathy (IgAN), Membranous Nephropathy, ANCA-associated Vasculitis (AAV)/ANCA-associated Glomerulonephritis (AAGN), Refractory Podocytopathy
- Trial name
- NCT07389499
- Testing
- CD19-targeted iNKT Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Grit Biotechnology
Phenylketonuria (PKU)
To Evaluate the Safety and Efficacy of GS1168 Injection in Adult Phenylketonuria
This study is a single-arm, open-label, dose-escalation, exploratory study to evaluate the safety, tolerability, and efficacy of a single administration of GS1168 Injection in Chinese adult phenylketonuria (PKU) with PAH mutation.
- Trial name
- NCT07318909
- Testing
- GS1168 injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Gritgen Therapeutics Co., Ltd.
NSCLC
Safety and Efficacy of NK510 to Treat NSCLC
This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural…
- Trial name
- NCT06097962
- Testing
- NK510, Tislelizumab，atezolizumab or sugemalimab, systemic therapy as selected by the investigator
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
Healthy Adult, Prostate Cancer
The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer
This goal of this study is to investigate the dosimetry, safety, biodistribution of ⁶⁸Ga-FC516. In this study, we will evaluate the safety, biodistribution and dosimetry of ⁶⁸Ga-FC516 in subjects and compared them with the…
- Trial name
- NCT07468708
- Testing
- ⁶⁸Ga-FC516, ⁶⁸Ga-FC516 and ⁶⁸Ga-labeled prostate cancer-targeting tracer
- Where
- China
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.
Relapsed/Refractory Hematologic Malignancies
Dose-Escalation/Expansion Study of iMagic in Relapsed/Refractory Hematologic Malignancies
This is an investigator-initiated, single-center, dose-escalation and dose-expansion early-phase clinical study to evaluate the safety and efficacy of iMagic Injection in participants with hematologic malignancies.
- Trial name
- NCT07802756
- Testing
- iMagic Injection (IMV101), iMagic Injection (IMV102)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Suzhou Immunofoco Biotechnology Co., Ltd
High-grade Squamous Intraepithelial Lesions (HSIL)
A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL
This study is intented to evaluate the safety, and tolerability and preliminary efficacy of Instantaneous CRISPR/Cas9 Gene Editing Therapy (BD114 virus-like particle, also BD114) for the treatment of high-grade squamous…
- Trial name
- NCT07170254
- Testing
- BD114VLP, or BD114
- Where
- China
- Volunteers
- 2 people
- Sponsor
- Shanghai BDgene Co., Ltd.
Prostate Cancer
The Safety, Dosimetry and Efficacy of 177Lu-FC516 in Patients With Prostate Cancer
This study is a prospective, single-arm, open-label, dose-escalation study. A total of 5 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles.
- Trial name
- NCT07542379
- Testing
- 177Lu-FC516
- Where
- China
- Volunteers
- 13 people
- Sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.
Maligant Solid Tumor, Head & Neck Cancer
The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors
This study is a prospective, single-arm, open-label, dose-escalation study. A total of 4 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles.
- Conditions
- Maligant Solid Tumor, Head & Neck Cancer, Thyroid Cancer, Lung Cancer - Non Small Cell Squamous
- Trial name
- NCT07459283
- Testing
- INN805
- Where
- China
- Volunteers
- 10 people
- Sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.
Relapsed/Refractory Multiple Myeloma
A Study of IMV102 in Patients With Relapsed/Refractory Multiple Myeloma
This is an investigator-initiated, single-center, early-phase clinical study comprising dose escalation and dose expansion phases, designed to evaluate the safety and efficacy of IMV102 in subjects with relapsed/refractory…
- Trial name
- NCT07493135
- Testing
- IMV102 treatment
- Where
- 4 sites in China
- Volunteers
- 30 people
- Sponsor
- Suzhou Immunofoco Biotechnology Co., Ltd
Cutaneous Lupus Erythematosus
Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2.
- Trial name
- HERACLES (NCT07072611)
- Testing
- SOF-SKN 0.25%, SOF-SKN 0.5%, SOF-SKN 1%
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Noxopharm Limited