Hemolytic Disease of the Newborn

Researchers are evaluating nipocalimab to reduce the risk of fetal anemia and other serious complications in pregnancies at high risk for severe Hemolytic Disease of the Fetus and Newborn HDFN. The study compares nipocalimab to a placebo in pregnant participants to see if it can decrease risks like fetal loss, the need for intrauterine transfusions, hydrops fetalis, or neonatal death. This phase 3 trial focuses on pregnancies with maternal alloantibody presence and previous severe HDFN history. Participants receive either nipocalimab or a matching placebo through weekly intravenous infusions starting at randomization until gestational week 35. The study is randomized and triple-masked, meaning neither participants nor researchers know who receives the drug or placebo. The treatment period covers the pregnancy phase where risk is highest, with careful monitoring throughout. During the study, participants undergo various assessments including lab tests, antibody titers, fetal antigen testing, and physical exams to monitor health. Researchers track pregnancy outcomes through delivery and up to 4 weeks after birth or 41 weeks postmenstrual age for newborns. Long-term infant health, including development and complications related to HDFN, is followed for up to 104 weeks. Safety and maternal outcomes are also closely observed until 24 weeks postpartum.

Researchers are studying nipocalimab to see if it can reduce the risk of severe fetal and neonatal alloimmune thrombocytopenia FNAIT compared to a placebo. This condition affects newborns and can lead to low platelet counts and serious bleeding. The trial is designed as a double-blind, randomized, placebo-controlled study focusing on pregnant women at risk of FNAIT. Participants will be randomly assigned to receive either nipocalimab or a placebo through intravenous infusions. The study includes pregnant women between 13 and 18 weeks of gestation who have a history of FNAIT in prior pregnancies and meet specific antibody and fetal genotype criteria. Treatment will continue with monitoring up to 24 weeks postpartum, with safety and effectiveness closely evaluated. During the study, participants and their babies will undergo various assessments including blood platelet counts at birth, bleeding events monitoring, and developmental evaluations up to 104 weeks. Maternal health will be monitored through physical exams, laboratory tests, and ECGs. Researchers will track adverse events and antibody responses to nipocalimab, aiming to understand its impact on reducing risks associated with FNAIT while ensuring maternal and infant safety.

Researchers are evaluating the efficacy and safety of nipocalimab compared to intravenous immunoglobulin IVIG in pregnant women at risk of fetal and neonatal alloimmune thrombocytopenia FNAIT, a condition where maternal antibodies attack fetal platelets. This Phase 3 trial aims to reduce the risk of severe bleeding or low platelet counts in affected fetuses and newborns. The study is sponsored by Janssen Research & Development, LLC and focuses on pregnancies complicated by specific maternal alloantibodies and fetal genotypes. Participants are randomly assigned to receive either nipocalimab or IVIG treatments during pregnancy. Nipocalimab is given intravenously starting between 13 to 18 weeks of gestation until delivery. Those receiving IVIG start at gestational week 12 for high-risk pregnancies or week 20 for standard-risk pregnancies, with oral prednisone added per protocol and tapered off after delivery based on tolerance and investigator judgment. Both treatments are studied for their impact on fetal and neonatal outcomes. During the study, participants undergo assessments including physical exams, vital signs, ECGs, and laboratory tests to monitor health and response. Researchers will track outcomes such as fetal or neonatal death, severe bleeding, and platelet counts up to one week after birth. Long-term follow-up includes developmental assessments at 52 and 104 weeks and monitoring for treatment-emergent adverse events in mothers and infants. The overall participation period extends through delivery and includes postnatal evaluations for both mother and child.

Researchers are studying pregnant individuals at risk for hemolytic disease of the fetus and newborn HDFN, a condition where incompatible blood types between mother and baby cause rapid breakdown of fetal or newborn red blood cells. This observational study aims to evaluate the risk of anemia in fetuses and newborns receiving standard care, tracking outcomes from pregnancy through two years after birth. The study looks at complications such as fetal loss, transfusions, and neonatal death to better understand HDFNs impact. Participants receive standard medical care for HDFN as per local clinical practice without additional study treatments. Data collection occurs throughout pregnancy and continues for two years after birth for the baby. Participants will provide medical information and complete questionnaires at set times during follow-up. Data is gathered from medical centers that routinely treat HDFN to capture comprehensive clinical outcomes. During the study, researchers will collect detailed medical records, including clinical outcome assessments reported by patients or observers. They will measure outcomes such as fetal loss, intrauterine transfusions, hydrops fetalis, neonatal death, and disease severity. The study tracks pregnancies from conception through the neonatal period and continues monitoring infants up to two years. This long-term follow-up helps understand the course and effects of HDFN under standard care conditions.

Researchers are evaluating the safety, tolerability, and best dose for Phase 2 of KLN-1010, a new gene therapy, in patients with relapsed or refractory multiple myeloma. This treatment aims to generate anti-B cell maturation antigen Anti-BCMA CAR-T cells directly in the body to target cancer cells. The trial is a Phase 1 study sponsored by Kelonia Therapeutics, Inc. and focuses on patients who have received multiple prior therapies. Participants receive a single specified dose of KLN-1010 during the treatment phase. The study follows them for up to 15 years after dosing to monitor safety and establish the recommended dose for future testing. Pharmacokinetics, including how the drug and CAR-T cells behave in the body, are assessed for up to two years. Disease status is also tracked from dosing until progression or for up to 15 years. Throughout the study, participants undergo regular evaluations including safety assessments for adverse events and dose-limiting toxicities. Laboratory tests and clinical assessments measure how the therapy affects the disease and the participants health. Long-term monitoring ensures ongoing safety and effectiveness measurements, with the entire participation lasting up to 15 years after treatment.

Researchers are evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of an anti-GPRC5D CAR-T cell product called OriCAR-017 in adults with relapsed or refractory multiple myeloma. This Phase III open-label study is the first clinical trial of OriCAR-017 in the United States by OriCell Therapeutics Co., Ltd., aiming to find suitable dosing and assess early treatment results in this patient group. The study includes a Phase I dose escalation stage with three different doses given as a single intravenous infusion to up to 18 participants. This is followed by a dose expansion stage with 10-15 participants and then a Phase II stage that may include up to 48 participants. Each participant receives one infusion of OriCAR-017 to evaluate its effects and safety. Participants will be closely monitored for up to two years after treatment. Researchers will assess the maximum tolerated dose and dose-limiting toxicities within 28 days after infusion. They will also study how the drug moves through and affects the body, measure response duration, progression-free survival, overall survival, and other response rates. Regular evaluations include laboratory tests, clinical assessments, and safety monitoring throughout the study period.

Researchers are evaluating the safety and clinical activity of different doses of belantamab mafodotin combined with lenalidomide, dexamethasone, and nirogacestat in patients with newly diagnosed multiple myeloma who are not able to undergo a transplant. This phase 12, open-label study aims to find the recommended dose for future studies and to explore how to manage eye-related side effects. About 36 participants will be enrolled, with follow-up lasting up to 3 to 4 years after enrollment ends. Belantamab mafodotin is given intravenously every other 28-day cycle at doses ranging from 1.0 to 1.9 mgkg. Lenalidomide is taken orally daily on days 1 to 21 of each 28-day cycle. Dexamethasone is given either orally or intravenously on days 1, 8, 15, and 22 of each cycle, with dose adjustments based on age. Nirogacestat is taken twice daily starting three days before the first dose and on the same days as belantamab mafodotin. The study has two parts dose finding to establish the best dose, followed by dose expansion with random assignment to different dose modification guidelines for eye side effects. Participants will undergo regular assessments to monitor side effects, including eye exams, and overall response to treatment. Researchers will track dose-limiting toxicities, adverse events, ocular toxicity, and response rates over up to four years. Additional evaluations include measuring drug levels, disease progress, and survival. Participants must provide consent and will be closely monitored throughout the study period, which is expected to last approximately four years in total.

Researchers are evaluating the safety and feasibility of lung transplants from blood group A2 donors to blood group O recipients. This study aims to increase the donor pool for blood group O lung transplant candidates, who often face longer wait times and higher mortality on the waitlist. It is the first prospective study worldwide to assess ABO-incompatible lung transplants in this way. The intervention involves lung transplant surgery using lungs from blood group A2 donors transplanted into blood group O recipients who have low anti-A antibody levels and a negative virtual crossmatch at the time of transplant. The study monitors the recipients closely after surgery to assess immune response and transplant success. Participants will be monitored through various evaluations including antibody levels on post-operative days 5 or 12, primary graft dysfunction grading in the first three days, and assessment for rejection or infection over the following years. Long-term follow-up up to 10 years will evaluate graft function, chronic lung problems, infections, malignancies, and survival outcomes. The total participation time varies depending on individual follow-up and outcomes.

This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse SUPC, a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.

This research aims to find out if giving plasma from a donor who recently had Chikungunya infection to newborns whose mothers have peripartum Chikungunya infection can improve the chances of newborns surviving without brain inflammation or damage within the first five days of life. The study will compare these results with a group of newborns who did not receive plasma transfusion due to delays in diagnosis or transfer, or parental refusal. The trial is led by the Centre Hospitalier Universitaire de la Runion and includes newborns up to 2 days old. Participants in the treatment group will receive a plasma transfusion from donors who declared Chikungunya infection less than six months ago. This treatment is given to newborns whose mothers were diagnosed with Chikungunya infection around the time of birth. Newborns will be treated within 12 hours of birth or diagnosis depending on timing. There is also a parallel observational group of newborns who will not receive plasma but will be monitored as part of standard care. During the study, newborns will have daily medical and biological tests from day 1 to day 7, and a follow-up visit between 1 and 3 months of age. For the observational group, data collected during routine care up to 3 months will be used for research. Researchers will measure the effectiveness of early plasma administration in preventing neonatal brain inflammation or damage within five days after treatment. Safety and health will be monitored throughout the trial period, which is planned to end in late 2027.