Clinical trials: Phase 1
Advanced Renal Cell Carcinoma, Advanced Mesothelioma
Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma
To find a recommended dose of donated NK cells that can be given with lymphodepleting chemotherapy to patients with advanced renal cell carcinoma, mesothelioma, or osteosarcoma. The effects of this therapy will also be studied.
- Conditions
- Advanced Renal Cell Carcinoma, Advanced Mesothelioma, Advanced Osteosarcoma
- Trial name
- NCT05703854
- Testing
- CAR.70/IL15-transduced CB-derived NK cells, Fludarabine phosphate, Cyclophosphamide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- M.D. Anderson Cancer Center
Systemic Lupus Erythematosus
Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus
This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics…
- Trial name
- CARLYSLE (NCT06333483)
- Testing
- Obecabtagene autoleucel (obe-cel)
- Where
- 6 sites in Spain, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Autolus Limited
Pitt Hopkins Syndrome
Phase 1/2 Study of MZ-1866, an AAV-9 Gene Therapy Delivered by Intracerebroventricular Injection to Participants With Pitt Hopkins Syndrome
The goal of this clinical trial is to learn if MZ-1866 is a safe and tolerable treatment for children and adults with Pitt Hopkins Syndrome.
- Trial name
- NCT07135050
- Testing
- MZ-1866
- Where
- 4 sites in United States, Israel
- Volunteers
- 12 people
- Sponsor
- Mahzi Therapeutics
Advanced NUT Carcinoma, Metastatic NUT Carcinoma
Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with cisplatin and etoposide or carboplatin and paclitaxel in treating patients with NUT carcinoma.
- Conditions
- Advanced NUT Carcinoma, Metastatic NUT Carcinoma, Unresectable NUT Carcinoma
- Trial name
- NCT05019716
- Testing
- BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure, Biospecimen Collection
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
This phase I trial tests the safety, side effects, and best dose of ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm
- Trial name
- NCT05372640
- Testing
- Abemaciclib, BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- National Cancer Institute (NCI)
Pediatric HIV Infection, Tuberculosis Infection
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV/TB cotreatment strategies in children.
- Trial name
- NCT05069688
- Testing
- rifampicin
- Where
- Nigeria
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
Adolescence Obesity
Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents
This is a Phase Ib, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Efsubaglutide Alfa Injection following multiple-dose…
- Trial name
- NCT07693426
- Testing
- Efsubaglutide Alfa 5 mg QW, Efsubaglutide Alfa 10 mg QW, Efsubaglutide Alfa 20 mg QW
- Where
- 5 sites in China
- Volunteers
- 36 people
- Sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Epstein-Barr Virus, Cytomegalovirus Infections
R-MVST Cells for Treatment of Viral Infections in Children and Young Adults
The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV)…
- Conditions
- Epstein-Barr Virus, Cytomegalovirus Infections, Adenovirus, BK Virus Infection
- Trial name
- NCT06926894
- Testing
- Rapidly generated virus specific T (R-MVST) cells
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Monica Bhatia
Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Malignant Glioma
Savolitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors
This phase I trial studies the side effects and best dose of savolitinib in treating patients with primary central nervous system (CNS) tumors that have come back (recurrent) or does not respond to treatment (refractory).
- Conditions
- Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Primary Central Nervous System Neoplasm
- Trial name
- NCT03598244
- Testing
- Biospecimen Collection, Magnetic Resonance Imaging, Savolitinib
- Where
- 12 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- National Cancer Institute (NCI)
Refractory Lupus Nephritis, Systemic Sclerosis
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension…
- Conditions
- Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension, Other Autoimmune Diseases (AID)
- Trial name
- NCT06947460
- Testing
- CD19-BCMA CAR-T cells infusion
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Beijing GoBroad Hospital
Amblyopia, Amblyopia Unilateral
Valproate for the Treatment of Residual Amblyopia
The goal of this clinical trial is to determine the efficacy of valproate as an adjunct therapy to treat amblyopia beyond the critical period in children aged 8-17 years who have amblyopia of ≥3 lines of interocular…
- Conditions
- Amblyopia, Amblyopia Unilateral, Amblyopia, Anisometropic, Amblyopia Strabismic
- Trial name
- VARA (NCT07226141)
- Testing
- Valproate, Patch
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Boston Children's Hospital
Pediatric HIV Infection, Latent Tuberculosis
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children.
- Trial name
- NCT06281834
- Testing
- Rifapentine, Dolutegravir
- Where
- Nigeria
- Volunteers
- 25 people
- Sponsor
- Brigham and Women's Hospital
Sickle Cell Disease
TMLI and Alemtuzumab for Treatment of Sickle Cell Disease
This phase I trial tests the safety and effectiveness of total marrow and lymphoid irradiation (TMLI) and alemtuzumab as a conditioning regimen in patients with sickle cell disease.
- Trial name
- NCT05384756
- Testing
- Alemtuzumab, Hematopoietic Cell Transplantation, Intensity-Modulated Radiation Therapy
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
Osteosarcoma, Osteosarcoma in Children
Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
The purpose of this study is to evaluate the safety and efficacy of nivolumab, or nivolumab in combination with azacitidine in participants with recurrent, resectable osteosarcoma
- Conditions
- Osteosarcoma, Osteosarcoma in Children, Osteosarcoma Recurrent, Sarcoma
- Trial name
- NCT03628209
- Testing
- Nivolumab, Azacitidine, Post Treatment Surgery
- Where
- 22 sites in United States
- Volunteers
- 21 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Solid Tumors, Neuroblastoma
Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors
A pilot pharmacokinetic trial to determine the safety and efficacy of a flavored, orally administered irinotecan VAL-413 (Orotecan®) given with temozolomide for treatment of recurrent pediatric solid tumors including but not…
- Conditions
- Solid Tumors, Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma
- Trial name
- NCT04337177
- Testing
- VAL-413, Temozolomide
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Valent Technologies, LLC
Sickle Cell Disease
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications…
- Trial name
- R34 pK/PD (NCT02447874)
- Testing
- Arginine, Arginine (Loading), Arginine (Continuous)
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Emory University
Central Nervous System Tumors
Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors
This study consists of 2 parts: Dose Escalation Part 1 and Dose Expansion Part 2. The Dose Escalation Part 1 will evaluate the safety and tolerability of Avelumab in combination with Lenvatinib and determine the recommended…
- Trial name
- NCT05081180
- Testing
- Avelumab, Lenvatinib
- Where
- 9 sites in Canada, France and 2 more
- Volunteers
- 17 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Synovial Sarcoma, Myxoid/Round Cell Liposarcoma
Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1
The goal of this clinical research study is to find a recommended dose of donated NK cells that can be given along with chemotherapy to patients with advanced cancers. The safety and effects of this therapy will also be studied.
- Trial name
- NCT06083883
- Testing
- Fludarabine phosphate, NY-ESO-1 TCR/IL-15 NK, Cyclophosphamide
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- M.D. Anderson Cancer Center
Clift Lip, Cleft Palate
Description of Pain in Pediatric Patients With Cleft Lip and Palate Undergoing Alveolar Grafting Using Two Surgical Strategies: Stem Cells and Autogenous Iliac Crest Bone (Pain Evaluation in Children Undergoing Alveolar Grafting: Stem Cells vs. Iliac Crest Bone)
Study Objective The objective of this study was to evaluate and compare postoperative pain and hospital costs in pediatric patients with cleft lip and palate undergoing alveolar bone grafting surgery.
- Conditions
- Clift Lip, Cleft Palate, Alveolar Bone Loss, Postoperative Pain
- Trial name
- NCT07734974
- Testing
- Autogenous Iliac Crest Bone Grafting, Bioengineered Alveolar Grafting (SHED + Scaffold)
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- Hospital Sirio-Libanes
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics
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