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A Phase 2 Study of CRG-022 in Patients With Relapsed/Refractory Large B-cell Lymphoma
CARGO Therapeutics
Cancer
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
This is a prospective, open-label, multi-center clinical study designed to evaluate the
safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of
CRG-022, a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the
treatment... expand
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of CRG-022, a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). Type: Interventional Start Date: Aug 2023 |
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
Pfizer
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
The purpose of this study is to learn about the effects, safety and how PF-06823859 is
processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus
(SLE) showing some skin symptoms.
This study is seeking for participants who:
-... expand
The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms. This study is seeking for participants who: - are adults of 18 years of age or older. - are confirmed to have CLE or SLE with involvement of the skin. - have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8. About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins). At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60. The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period. Type: Interventional Start Date: Jul 2023 |
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous...
Bristol-Myers Squibb
Multiple Myeloma
The purpose of this study is to compare the effectiveness of iberdomide maintenance to
lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in
participants with newly diagnosed multiple myeloma (NDMM).
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The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM). Type: Interventional Start Date: Jun 2023 |
Hyperpolarized 129Xe MRI Lung Health Cohort
University of Kansas Medical Center
Healthy
A subset of young adults participating in the American Lung Association (ALA) Lung Health
Cohort (LHC) will be imaged using Hyperpolarized 129Xe MRI to assess lung structure and
function. Images will be used to improve the understanding of lung health and early lung
abnormalities... expand
A subset of young adults participating in the American Lung Association (ALA) Lung Health Cohort (LHC) will be imaged using Hyperpolarized 129Xe MRI to assess lung structure and function. Images will be used to improve the understanding of lung health and early lung abnormalities that may lead to chronic lung disease. Type: Observational Start Date: Nov 2023 |
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI)...
MeMed Diagnostics Ltd.
Lower Respiratory Tract Infection
This is a Prospective, multi-center study enrolling adults subjects presented to the
ED/Urgent care, with symptoms consistent with lower respiratory infection (LRTI).
The reason of this study is to demonstrate the MeMed BV can help clinicians make decisions
about using antibiotics... expand
This is a Prospective, multi-center study enrolling adults subjects presented to the ED/Urgent care, with symptoms consistent with lower respiratory infection (LRTI). The reason of this study is to demonstrate the MeMed BV can help clinicians make decisions about using antibiotics in patients with lower respiratory track infections and see how it would impact clinical outcomes, antibiotics use, hospitalizations, ED clinicians find ways to improve health and medical care. Type: Interventional Start Date: Jan 2023 |
Trial Readiness and Endpoint Assessment in LGMD R1
Virginia Commonwealth University
Calpain-3 Deficiency Limb Girdle Muscular Dystrophy Type 2A
Limb Girdle Muscular Dystrophy
Limb Girdle Muscular Dystrophy Type R1
LGMD2A
This is a 24-month, observational study of 100 participants with Limb Girdle Muscular
Dystrophy type R1, also known as CAPN3.
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This is a 24-month, observational study of 100 participants with Limb Girdle Muscular Dystrophy type R1, also known as CAPN3. Type: Observational Start Date: Jan 2024 |
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Nikki Nollen, PhD, MA
Smoking Reduction
This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th
generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from
combustible cigarettes to e-cigarettes in adult menthol smokers.
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This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers. Type: Interventional Start Date: Nov 2022 |
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab...
Gilead Sciences
Triple Negative Breast Cancer
PD-L1 Positive
The primary objective of this study is to compare the progression-free survival (PFS) between
sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice
(TPC) and pembrolizumab in participants with previously untreated, locally advanced
inoperable... expand
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). Type: Interventional Start Date: Jul 2022 |
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's...
Genentech, Inc.
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and
safety of giredestrant plus everolimus compared with the physician's choice of endocrine
therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal
growth... expand
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting. Type: Interventional Start Date: Aug 2022 |
MRI for Screening and Monitoring Scleroderma ILD
University of Kansas Medical Center
Scleroderma
The purpose of this study is to test MRI methods for evaluating patients with
Scleroderma-associated interstitial lung disease.
expand
The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease. Type: Observational Start Date: May 2022 |
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Celgene
Eosinophilic Esophagitis
This study is an open-label, uncontrolled study design to evaluate the long-term safety and
tolerability of treatment with CC-93538. The study will enroll participants who participated
in the CC-93538-EE-001 or CC-93538-DDI-001 studies.
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This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies. Type: Interventional Start Date: Sep 2021 |
Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative...
Amgen
Ulcerative Colitis
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of
clinical remission in participants with moderately to severely active ulcerative colitis
(UC).
Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo... expand
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product. Type: Interventional Start Date: Jan 2022 |
Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and...
Merck Sharp & Dohme LLC
Squamous Cell Carcinoma of Head and Neck
This study is designed to assess the safety and efficacy of lenvatinib in combination with
pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and
efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck... expand
This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Type: Interventional Start Date: Aug 2020 |
Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication...
National Cancer Institute (NCI)
Castration-Resistant Prostate Carcinoma
Metastatic Malignant Neoplasm in the Lymph Nodes
Metastatic Prostate Carcinoma
Stage IV Prostate Cancer AJCC v8
This phase I/II trial studies the best dose of M3814 when given together with radium-223
dichloride or with radium-223 dichloride and avelumab and to see how well they work in
treating patients with castrate-resistant prostate cancer that had spread to other places in
the... expand
This phase I/II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy. Type: Interventional Start Date: Oct 2020 |
An Assessment of Cognitive Improvement Training Among Mid-life Individuals
University of Kansas
Delay Discounting
Many health-relevant decisions involve intertemporal (now vs. later) tradeoffs. Extensive
literature indicates that many negative health and financial consequences suffered in
mid-life are linked to adversity and disadvantage during early developmental periods of life.
Individuals... expand
Many health-relevant decisions involve intertemporal (now vs. later) tradeoffs. Extensive literature indicates that many negative health and financial consequences suffered in mid-life are linked to adversity and disadvantage during early developmental periods of life. Individuals who continue to engage in these types of unhealthy behaviors despite awareness of the health consequences are exhibiting an inability to delay gratification. Delay discounting (DD) is quantified in human studies by determining the rate at which an individual discounts a delayed reward, while executive function (EF) is defined as the set of cognitive processes that are responsible for helping individuals manage life tasks and achieve goals. This research will attempt to reduce DD via EF training in a population of mid-life individuals with risk factors established during early-life disadvantage. Type: Interventional Start Date: Nov 2014 |
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary...
Pliant Therapeutics, Inc.
Idiopathic Pulmonary Fibrosis
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy
and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis
(BEACON-IPF).
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A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF). Type: Interventional Start Date: Nov 2023 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive...
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278
in Participants with Progressive Pulmonary Fibrosis.
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
Donor-Derived Anti-CD33 CAR T Cell Therapy (VCAR33) in Patients With Relapsed or Refractory AML After...
Vor Biopharma
Leukemia, Myeloid, Acute
This is a Phase 1/2, multicenter, open-label, first-in-human (FIH) study of donor-derived
anti-CD33 Chimeric Antigen Receptor (CAR) T cell therapy (VCAR33) in patients with relapsed
or refractory Acute Myeloid Leukemia (AML) after human leukocyte antigen (HLA)-matched
allogeneic... expand
This is a Phase 1/2, multicenter, open-label, first-in-human (FIH) study of donor-derived anti-CD33 Chimeric Antigen Receptor (CAR) T cell therapy (VCAR33) in patients with relapsed or refractory Acute Myeloid Leukemia (AML) after human leukocyte antigen (HLA)-matched allogeneic hematopoietic cell transplant (alloHCT). Type: Interventional Start Date: Dec 2023 |
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
GB002, Inc.
Pulmonary Arterial Hypertension
The primary objective of the study is to determine the effect of seralutinib on improving
exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary
objective for this trial is to determine time to clinical worsening.
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The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening. Type: Interventional Start Date: Dec 2023 |
A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic...
Beam Therapeutics Inc.
Lymphoblastic Lymphoma
T-Cell Lymphoblastic Leukemia/Lymphoma
Lymphoblastic Leukemia
This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of
BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1
dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will... expand
This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to < 12 years), and a Phase 2 cohort. Type: Interventional Start Date: May 2023 |
A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
GEn1E Lifesciences
Respiratory Distress Syndrome, Acute
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of
GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after
ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first
dose... expand
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days. Type: Interventional Start Date: Apr 2023 |
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis...
Genentech, Inc.
Idiopathic Pulmonary Fibrosis
Systemic Sclerosis With Lung Involvement
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants... expand
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Type: Interventional Start Date: May 2023 |
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Celldex Therapeutics
Eosinophilic Esophagitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult
Eosinophilic Esophagitis patients.
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The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients. Type: Interventional Start Date: Jun 2023 |
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine,...
Kura Oncology, Inc.
Acute Myeloid Leukemia
Mixed Lineage Acute Leukemia
Mixed Lineage Leukemia Gene Mutation
Mixed Phenotype Acute Leukemia
Refractory AML
This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic
activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3
for two different molecularly-defined arms, NPM1-m and KMT2A-r.
expand
This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r. Type: Interventional Start Date: Jul 2023 |
Study of M5049 in DM and PM Participants (NEPTUNIA)
EMD Serono Research & Development Institute, Inc.
Dermatomyositis
Polymyositis
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049
in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis
(PM) participants for 24 weeks.
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The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks. Type: Interventional Start Date: Jan 2023 |
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