Clinical trials: Phase 1
Acute Lymphoblastic Leukemia Recurrent, B-cell Lymphoma Recurrent
MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM)
This is a phase l multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients.
- Conditions
- Acute Lymphoblastic Leukemia Recurrent, B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory, Chronic Lymphocytic Leukemia Recurrent
- Trial name
- NCT03853616
- Testing
- MB-CART19.1
- Where
- 9 sites in Germany
- Volunteers
- 48 people
- Sponsor
- Miltenyi Biomedicine GmbH
Hypothalamic Obesity, Prader-Willi Syndrome
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment
- Conditions
- Hypothalamic Obesity, Prader-Willi Syndrome, PWS
- Trial name
- NCT06239116
- Testing
- Part C: RM-718, Part D: RM-718
- Where
- 7 sites in United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia
- Trial name
- AUGMENT-101 (NCT04065399)
- Testing
- revumenib, cobicistat
- Where
- 57 sites in United States, Australia and 9 more
- Volunteers
- 447 people
- Sponsor
- Syndax Pharmaceuticals
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)
This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory…
- Trial name
- NCT06173518
- Testing
- AUTO1
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 30 people
- Sponsor
- Autolus Limited
Relapsed/Refractory KMT2A-r Acute Leukemia, Relapsed/Refractory NUP98-r Acute Leukemia
Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia
The primary objective of the trial is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based…
- Conditions
- Relapsed/Refractory KMT2A-r Acute Leukemia, Relapsed/Refractory NUP98-r Acute Leukemia, Relapsed/Refractory NPM1-m Acute Leukemia
- Trial name
- NCT06376162
- Testing
- Ziftomenib, Cytarabine, Fludarabine
- Where
- 20 sites in United States, Austria and 5 more
- Volunteers
- 20 people
- Sponsor
- PedAL BCU, LLC
Acute Myeloid Leukemia, Accelerated Phase Chronic Myeloid Leukemia
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to < 18 years with advanced leukemias, lymphomas, and solid tumors.
- Conditions
- Acute Myeloid Leukemia, Accelerated Phase Chronic Myeloid Leukemia, Blast Phase Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia
- Trial name
- NCT03934372
- Testing
- Ponatinib
- Where
- 23 sites in Belgium, France and 5 more
- Volunteers
- 70 people
- Sponsor
- Incyte Biosciences International Sàrl
Congenital Mullerian Duct Anomaly
Implantation Of Vaginal Construct For Patients With Vaginal Aplasia
In this Phase 1, single site, clinical trial, Vulvar/vaginal Smooth muscle cells (SMC) and Epithelial Cells (EPC) are isolated from autologous patient's biopsy
- Trial name
- TEV (NCT05675722)
- Testing
- biologic vaginal-construct implantation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Wake Forest University Health Sciences
Glioma
Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation
The goal of this clinical research study is to learn about the safety and effects of M032 given directly into the tumor in children and adults with DMG and who have received standard-of-care radiation therapy.
- Trial name
- NCT07076498
- Testing
- M032
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- M.D. Anderson Cancer Center
Ovarian Cancer, Endometrial Cancer
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor, Testicular Germ Cell Tumor
- Trial name
- NCT06276491
- Testing
- XmAb541
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 282 people
- Sponsor
- Xencor, Inc.
Hidradenitis Suppurativa
Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
- Trial name
- NCT07049575
- Testing
- Ruxolitinib Cream
- Where
- 21 sites in United States
- Volunteers
- 24 people
- Sponsor
- Incyte Corporation
Solid Tumor, Urethral Cancer
Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors
The goal of this clinical research study is to find the highest tolerable dose of Gemzar® (gemcitabine) and Adriamycin® (doxorubicin) that can be given together with Velcade® (bortezomib) in patients with urothelial cancer or…
- Trial name
- NCT00479128
- Testing
- Bortezomib, Gemcitabine, Doxorubicin
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- M.D. Anderson Cancer Center
Solid Tumor, Childhood, Solid Tumor
Pilot Trial of Eltrombopag in Patients Undergoing Chemotherapy for Malignant Solid Tumors
Primary Objective: To assess safety of eltrombopag in pediatric patients undergoing intensive chemotherapy for malignant solid tumors.
- Trial name
- CCPO011 (NCT04485416)
- Testing
- Eltrombopag
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of California, Davis
Medulloblastoma, Central Nervous System Embryonal Tumor
GPC2-CAR T Cell Therapy for Relapsed or Refractory Medulloblastoma in Children and Young Adults
This is a single-site, open-label Phase I treatment study evaluating the manufacturing feasibility and safety of chimeric antigen receptor (CAR) T cells targeting the oncofetal protein Glypican-2 (GPC2) in pediatric and young…
- Conditions
- Medulloblastoma, Central Nervous System Embryonal Tumor, Refractory Medulloblastoma, Recurrent Medulloblastoma
- Trial name
- NCT07087002
- Testing
- GPC2-CAR T cells, Fludarabine, Cyclophosphamide
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Stanford University
Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma
Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma
This is a multiple center, non-randomized, open-label, phase 1/2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D).
- Conditions
- Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Large B-cell Lymphoma, Follicular Lymphoma Grade 3A
- Trial name
- NCT05326243
- Testing
- CD19-targeted chimeric antigen receptor T-cell
- Where
- 5 sites in Taiwan
- Volunteers
- 49 people
- Sponsor
- Pell Bio-Med Technology Co., Ltd.
Recurrent or Refractory Solid Tumors, Ewing Sarcoma
Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors
This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The goal is to find the highest dose of MM-398 that can be given safely when it is used together with the chemotherapy drug Cyclophosphamide.
- Conditions
- Recurrent or Refractory Solid Tumors, Ewing Sarcoma, Rhabdomyosarcoma, Neuroblastoma
- Trial name
- NCT02013336
- Testing
- MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- South Plains Oncology Consortium
Attention Deficit Hyperactivity Disorder
Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial
Background: Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions.
- Trial name
- NCT05608434
- Testing
- Non-adaptive Floreo VR control, Floreo Virtual Reality application
- Where
- United States
- Volunteers
- 219 people
- Sponsor
- National Institute of Mental Health (NIMH)
Recurrent Medulloblastoma, Refractory Medulloblastoma
A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)
The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent/refractory medulloblastoma or another type of cancer with CNS metastases.
- Conditions
- Recurrent Medulloblastoma, Refractory Medulloblastoma, CNS Metastases, Central Nervous System Metastasis
- Trial name
- NCT07698899
- Testing
- 25 mCi 177Lu- DTPA-omburtamab
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Medulloblastoma Recurrent, Medulloblastoma
Study of CDK8 Inhibitor RVU120 in Combination With Everolimus in Children With Recurrent or Progressive Group 3 or 4 Medulloblastoma
This study will determine the safety and tolerability of RVU120 as a single agent and in combination with the mTOR inhibitor everolimus in children with recurrent or progressive G3 or G4 medulloblastoma and provide preliminary…
- Trial name
- MEDWAY (NCT07865130)
- Testing
- RVU120, Everolimus (Afinitor) tablets
- Where
- Poland
- Volunteers
- 48 people
- Sponsor
- Bożenna Dembowska Bagińska
Osteosarcoma
A Phase I Feasibility And Safety Study of Fluorescein-Specific (FITC-E2) CAR T Cells In Combination With Parenterally Administered Folate-Fluorescein (UB-TT170) For Osteogenic Sarcoma
The purpose of this study is to see if a new treatment could help patients who have osteosarcoma that does not go away with treatment (is refractory) or comes back after treatment (is recurrent).This study is testing a…
- Trial name
- NCT05312411
- Testing
- SCRI-E2CAR_EGFRtv1, UB_TT170
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Seattle Children's Hospital
Pheochromocytoma, Endocrine Disease
Diagnosis of Pheochromocytoma
The goal of this study is to develop better methods of diagnosis, localization, and treatment for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often difficult to detect with current methods.
- Conditions
- Pheochromocytoma, Endocrine Disease, Endocrine Diseases
- Trial name
- NCT00004847
- Testing
- ([18F]-DOPA), ([18F]-6F-DA)
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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