Clinical trials: Phase 1
B Cell Precursor Acute Lymphoblastic Leukemia
A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to…
- Trial name
- NCT04521231
- Testing
- Blinatumomab
- Where
- 109 sites in United States, Argentina and 18 more
- Volunteers
- 181 people
- Sponsor
- Amgen
Ataxia Telangiectasia
Safety and Efficacy of Mutation-targeted Precision Genetic Therapy for Ataxia-Telangiectasia (A-T)
This project aims to evaluate the safety and efficacy of precision genetic therapy for patients with Ataxia-telangiectasia (A-T), a rare neurodegenerative disease caused by mutations in the ATM gene.
- Trial name
- NCT07215416
- Testing
- Antisense oligonucleotide targeting the ATM gene
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Timothy Yu
Adenovirus, Cytomegalovirus Infections
Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV or EBV in subjects who have previously received any type of…
- Conditions
- Adenovirus, Cytomegalovirus Infections, Epstein-Barr Virus
- Trial name
- NCT04364178
- Testing
- Adenovirus Specific T- Lymphocytes, Cytomegalovirus Specific T-Lymphocytes, EBV Specific T-Lymphocytes
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Jessie L. Alexander, MD
Solid Tumor
Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors
This study is being conducted in order to determine the safety, dose-limiting toxicities, and maximum tolerated dose of cabozantinib in combination with 13-cis-retinoic acid in patients with relapsed or refractory solid tumors…
- Trial name
- NCT03611595
- Testing
- Cabozantinib, 13-cis-retinoic acid
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Peter Zage
Locally Advanced Solid Tumors, Metastatic Solid Tumors
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult…
- Trial name
- TRIDENT-1 (NCT03093116)
- Testing
- Oral repotrectinib (TPX-0005)
- Where
- 165 sites in United States, Australia and 17 more
- Volunteers
- 500 people
- Sponsor
- Turning Point Therapeutics, Inc.
Locally Advanced Solid Tumor, Metastatic Solid Tumor
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced…
- Trial name
- NCT05384626
- Testing
- Neladalkib (NVL-655), Midazolam, Repaglinide
- Where
- 74 sites in United States, Australia and 13 more
- Volunteers
- 840 people
- Sponsor
- Nuvalent Inc.
B Cell Acute Lymphoblastic Leukemia (B-ALL), B Lineage Lymphoblastic Lymphoma
Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)
This study will determine the safety and efficacy of moving to a second-generation manufacturing process using the CliniMACS Prodigy platform to manufacture huCART19 cells for patients with B cell Acute Lymphoblastic Leukemia…
- Trial name
- NCT05480449
- Testing
- Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19)
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Stephan Grupp MD PhD
B Cell Lymphoma, Acute Lymphoblastic Leukemia, Pediatric
CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies
The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from pediatric and young adult subjects with relapsed/refractory B-cell malignancies (leukemia and…
- Conditions
- B Cell Lymphoma, Acute Lymphoblastic Leukemia, Pediatric, Lymphoma
- Trial name
- NCT04088864
- Testing
- Fludarabine, Cyclophosphamide, Autologous CD22 CAR T
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Kara Lynn Davis
Familial Hemophagocytic Lymphohistiocytosis Type 3 (FHL 3)
Safety and Efficacy of Gene Therapy of FHL Type 3 Caused by Mutations in the Human UNC13D Gene by Transplantation of a Single Dose of Autologous CD34+ Cells Transduced ex Vivo With the UNC13D LV Vector Expressing the UNC13D cDNA
The investigators propose to replace HLA- partially compatible allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for FHL type 3 patients, with autologous transplantation of immunoselected gene-modified CD34+ cells…
- Trial name
- MUNC13-4 (NCT06736080)
- Testing
- MUNC-CD34, MUNC-T3
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Gaucher Disease Type 3
A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of VGN-R08b in Patients With Type III Gaucher's Disease
A phase I/II clinical study to evaluate the tolerance, safety and efficacy of VGN-R08b intracerebroventricular injection in patients with type III Gaucher's disease
- Trial name
- NCT07603050
- Testing
- VGN-R08b
- Volunteers
- 12 people
- Sponsor
- Shanghai Vitalgen BioPharma Co., Ltd.
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT)
The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with…
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Autoimmune Diseases
- Trial name
- QSIT (NCT07221565)
- Testing
- Low-Frequency Electromagnetic Resonance Therapy (LF-EMR), Low-Dose Naltrexone (LDN)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Truway Health, Inc.
HIV
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1.
- Trial name
- NCT05406583
- Testing
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Where
- 15 sites in United States, South Africa and 1 more
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Sickle Cell Disease
Biotin-RBC Transfusion in SCD
This is a single-arm, mechanistic clinical trial to measure predictors of senescence and the in vivo survival of transfused red blood cells (RBCs) in individuals with sickle cell disease (SCD) receiving chronic transfusion…
- Trial name
- NCT04426591
- Testing
- Biotin Labeled Red Blood Cells, Pathogen-reduced Biotin Labeled Red Blood Cells
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Marianne Yee
Autism Spectrum Disorder
Low Intensity Focused Ultrasound in ASD
This study investigates the safety and potential efficacy of personalized, image-guided low intensity focused ultrasound (LIFU) targeting the thalamus in individuals with Autism Spectrum Disorder (ASD).
- Trial name
- NCT07225322
- Testing
- Active LIFU
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical University of South Carolina
Refractory Epilepsy, Drug Resistant Epilepsy
Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory Epilepsy
The main purpose of this study is to evaluate the safety and tolerability of a Leucine-Enriched Essential Amino Acid (LEAA) Powder as an add-on to a classic ketogenic diet (KD) in pediatric and adult patients with refractory…
- Trial name
- NCT06387186
- Testing
- Leucine-Enriched Essential Amino Acid powder
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Elizabeth Anne Thiele
Proven Pathogenic or Probably Pathogenic TBR1 Variant
A Study Evaluating 24 Months of Lithium Carbonate Treatment in Patients With TBR1-related Neurocognitive Disorder
TBR1 is a human gene encoding a brain-specific transcription factor, principally expressed in the excitatory neurons of the neocortex.
- Trial name
- ESALIT (NCT06776848)
- Testing
- Observation phase, Lithium treatment, biological monitoring
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Psoriasis
Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis
This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.
- Trial name
- NCT07340216
- Testing
- ARQ-154 Foam 0.3%
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Arcutis Biotherapeutics, Inc.
Refractory/Relapsed Acute Myeloid Leukaemia
Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia
This study is a multi-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory/relapsed acute myeloid leukaemia.
- Trial name
- NCT06326021
- Testing
- autologous FL-33 CAR T therapy, prior-HSCT donor-derived FL-33 CAR T therapy, Newly matched donor-derived FL-33 CAR T therapy
- Where
- 4 sites in China
- Volunteers
- 27 people
- Sponsor
- Beijing GoBroad Hospital
Skin Lesion, Nevus
Genetic Risk Stratification of Pediatric Skin Lesions
A study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether DermTech Pigmented Lesion Assay (PLA) genetic risk analysis of suspicious lesions in children correlates…
- Trial name
- NCT05418959
- Testing
- DermTech PLA noninvasive adhesive biopsy
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
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