Clinical Research Directory

Phase I Clinical Trial of ThINKK Adoptive Immunotherapy After Allogeneic Hematopoietic Transplantation in Children With Leukemia or Neuroblastoma

A first-in-class adoptive immunotherapy we called ThINKK, for Therapeutic Inducers of Natural Killer (NK) cell Killing, have been designed for use after hematopoietic stem cell transplantation (HSCT), where the proper stimulation of graft-derived NK cells has been shown to prevent relapse. ThINKK immunotherapy builds on our earlier research on NK cells and plasmacytoid dendritic cells (PDC) in cord blood and after HSCT. PDC are the sentinels of the immune system. Upon viral nucleic acids detection, PDC secrete a vast array of chemokines and cytokines that stimulate NK cells. PDC stimulation enhances NK cells killing of infected cells that express stress-induced molecules. Cancer cells also express stress-related molecules at their surface. However, NK cells do not receive PDC stimulation when fighting cancer. ThINKK therapy is designed to provide this necessary stimulation.

Animation-Based Education to Reduce Child and Parent Anxiety During Pediatric Stem Cell Transplantation (Cartoon-HSCT)

The goal of this clinical trial is to evaluate the effect of animation-based education on state anxiety levels of children and parents and on parental satisfaction with health care during the pediatric hematopoietic stem cell transplantation (HSCT) process. The main questions it aims to answer are: Does animation-based education reduce children's state anxiety before HSCT compared to standard verbal education? Does animation-based education reduce parental state anxiety and increase parental satisfaction with the care process? Researchers will compare children and parents who receive animation-based education with those who receive routine verbal education to see if the animation-based intervention leads to lower anxiety scores and higher satisfaction levels. Participants will: Watch a short age-appropriate animated video explaining the HSCT procedure in a positive and understandable way (intervention group), or receive standard verbal information (control group). Complete pre- and post-intervention questionnaires assessing child and parent state anxiety levels and parental satisfaction with care. The study includes children aged 4-10 years who are hospitalized for hematopoietic stem cell transplantation and their accompanying parents.

Psychosocial and Behavioral Intervention for Stem Cell Transplant Patients and Their Family Caregivers

Adherence to the medical regimen after stem cell transplant is challenging for both patients and their family caregivers. The investigators propose a randomized clinical trial testing two brief psychosocial interventions to determine if either improves patient and family caregiver psychosocial and health-related outcomes.

G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation

Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous hematopoietic stem cell transplantation. Currently mobilization regimens are not enough in increasing the yield of megakaryocytic or erythroid stem/progenitor cells, resulting in a delay of hematopoietic reconstitution of platelets and erythrocytes. IL-11 and G-CSF have a synergistic role in mobilizing peripheral blood stem cells towards megakaryocytic or erythroid stem/progenitor cells in a preclinical study. Furthermore, a single-center, small cohort, prospective clinical study that has been completed in China(ChiCTR2500100054), which showed that after five days of mobilization, the combination of G-CSF and IL-11 significantly increased the number and proportion of functional megakaryocytic/erythroid progenitor cells in the peripheral blood mononuclear cells of patients, and also significantly shortened the time for platelet engraftment after transplantation, and also reduced the demand for red blood cell and platelet transfusions compared to G-CSF alone. A multi-center, prospective random clinical study is essential to compare the efficacy and safety of novel mobilization regimen with IL-11 plus G-CSF to G-CSF alone.

Critical Illness After Hematopoietic Cell Transplantation

This is a prospective, multicenter observational trial for patients who develop critical illness after hematopoietic cell transplantation. Patients who are admitted to the intensive care unit after undergoing hematopoietic cell transplantation at the participating medical centers will be enrolled in this study. The clinical characteristics, laboratory profiles, managements, and clinical outcomes will be prospectively collected.

Virtual Reality Intervention for Symptom Management in Stem Cell Transplantation

The goal of this clinical trial is to evaluate whether a virtual reality (VR) intervention based on the Symptom Management Model can reduce physical and psychosocial symptoms during hematopoietic stem cell transplantation (HSCT) in adult patients undergoing allogeneic transplantation. The main questions it aims to answer are: Does the VR intervention reduce distress levels during HSCT? Does the VR intervention decrease state anxiety and symptom severity compared to standard care? Does the VR intervention positively affect physiological outcomes and engraftment times? Researchers will compare a group receiving standard clinical care plus a VR nature-themed video during HSCT to a group receiving standard care only to see if the VR intervention improves symptom management outcomes. Participants will: Be randomly assigned to either the intervention or control group. In the intervention group: Watch a 15-minute nature-themed VR video during stem cell infusion using Meta Quest 3. The video content will be specifically created by the research team based on the principles of Attention Restoration Theory (ART). In both groups: Complete pre- and post-intervention assessments including: Distress Thermometer State-Trait Anxiety Inventory Edmonton Symptom Assessment Scale Physiological measures (vital signs) Engraftment tracking Satisfaction and open-ended feedback forms

Exercise as an Immune Adjuvant for Allogeneic Cell Therapies

This study aims to improve the treatment of blood cancer by using exercise to collect healthier immune cells from donors. Allogeneic adoptive cell therapy is a treatment where immune cells from a healthy donor are given to a cancer patient, usually to help prevent or treat cancer relapse after a stem cell transplant. These donor cells can either be directly infused into the patient or grown in a lab to create more specialized immune cells that target and kill cancer. While this therapy has been helpful for many patients, there is a need to make it more effective for a larger group and reduce side effects like graft-versus-host disease (GvHD), where the donor's immune cells attack the patient's healthy tissue. This Early Phase 1 trial will test whether exercise can help produce better immune cells from donors. The investigators will recruit healthy participants for three study groups: 1. Exercise Group: Participants will complete a 20-minute cycling exercise session. The investigators will collect blood samples before, during, and after exercise to study the number and quality of immune cells. The investigators will also use the collected cells to create immune therapies and test their ability to kill cancer cells in the lab and control cancer growth in mice. 2. Exercise and Beta Blocker Group: In this group, participants will complete up to five cycling sessions, with at least a week between each session. Before each session, participants will take either a placebo or a drug (beta blocker) that blocks stress hormones like adrenaline. The investigators will collect blood samples before and during exercise to see how blocking these hormones changes the effect of exercise on immune cells. 3. Isoproterenol Group: Participants in this group will receive a 20-minute infusion of isoproterenol, a drug that mimics the effects of adrenaline. The investigators will collect blood samples before, during, and after the infusion to see if the drug causes similar immune changes to those caused by exercise. Participants can join one, two, or all three groups. This research will help understand whether exercise can improve immune cell therapies for treating blood cancer and reduce the risk of GvHD, making these treatments safer and more effective.