Clinical Research Directory

Coping Skills Training for Symptom Management and Daily Steps (Step Up)

The aim of this study is to test the efficacy of a hybrid in-person and mHealth coping skills training and activity coaching intervention (Step Up), to enable HCT patients to effectively cope with symptoms (pain, fatigue, and stress) to improve their ability to engage in physical activity that can improve physical disability.

Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Refractory Systemic Lupus Erythematosus

This is an investigator-initiated trial aimed at assessing the safety of anti-CD19 CAR-T cells in the treatment of refractory systemic lupus erythematosus.

RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients

This study evaluates whether the RSV vaccine Abrysvo can produce an antibody response in patients with blood cancers who have previously received a hematopoietic stem cell transplant (HSCT) or CAR-T cell therapy. The vaccine targets the prefusion F (preF) protein of RSV, which is an important component of protective immunity against the virus. The main goal of the study is to measure the change in antibody levels against the preF protein four weeks after vaccination compared with levels before vaccination. The study will also assess whether participants develop a meaningful immune response, defined as at least a four-fold increase in RSV neutralizing antibody levels four weeks after vaccination.

A Real-world Study on the Treatment of Adult B-cell Acute Lymphoblastic Leukemia With CNCT-19

This clinical study is a retrospective, observational, and multicenter post marketing real-world study aimed at evaluating the efficacy and safety of CNCT-19 in the treatment of Chinese adult B-cell acute lymphoblastic leukemia patients.

TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC

This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed/Refractory primary small cell lung cancer(r/r SCLC) who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in SCLC.

A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients

Study of Therapeutic Efficacy of CAR-T Cell Therapy in Patients With MDR-SRNS

This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS

Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL

At present, there is a lack of relevant research on the first-line treatment of high-risk CLL patients with BTKi combined with CAR-T. Therefore, our center plans to conduct a study on the treatment of newly diagnosed high-risk CLL patients with AntiCD19 CAR-T combined with BTKi, in order to increase the uMRD rate of newly diagnosed high-risk patients, thereby improving the long-term prognosis of high-risk CLL patients and reducing the long-term medication rate of CLL patients, providing more treatment options and hope for newly diagnosed high-risk CLL patients.

Pre-emptive Anakinra for Cytokine Event Reduction

Objectives: The primary objective of this study will be to evaluate the impact of pre-emptive use of anakinra on the rate of severe cytokine release syndrome (CRS) following CD19-directed chimeric antigen receptor (CAR) T-cell therapy for B-acute lymphoblastic leukemia (B-ALL) in children and young adults. Patient Population: Children and young adults \<25 years of age undergoing CAR T-cell therapy for B-ALL with bone marrow disease burden of ≥5% involvement or detectable peripheral blasts within 2 weeks of the initiation of lymphodepleting chemotherapy. Study Design: This is a pilot single arm study. The investigators will inquire into the efficacy and safety of using anakinra pre-emptively to reduce the rate of severe CRS in patients with \>/=5% bone marrow blasts or lymphoblasts in the peripheral blood. Treatment Plan: This is a single arm unblinded study in which patients will receive anakinra, 2.5 mg/kg (max 100mg), IV every 12 hours starting at the onset of persistent fever (fever \>38.5⁰ C x 2 occurrences separated by at least 4 hours in a 24 hour period). If there is persistence or progression of CRS, anakinra frequency will be increased to 2.5mg/kg IV (max 100mg), every 6 hours. Anakinra will be continued until 48 hours after resolution of CRS and ICANS, and at least 7 days post-CAR T infusion. If dose and frequency of anakinra is increased, the increased dose of anakinra will be continued until 48 hours after resolution of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) and at least 7 days post-CAR T infusion. For CRS worsening beyond dose escalation of anakinra, CRS will be managed as per standard of care management. Participants will be followed for 12 months following enrollment in the study and disease evaluations will be performed as per routine clinical care following CAR T-cell therapy.

Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cell Therapy in Patients With MDR-SRNS

This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-CD19 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS

Nutrition OUtReach In Systems of Healthcare

Many children and adults receiving medical treatments have higher costs, which can make it harder for them to afford groceries. When someone can't afford enough food, and they do not receive proper nutrition it can make treatment more difficult. By doing this study investigators hope to learn more about whether addressing food insecurity by giving patients bags of food in clinic can help improve nutrition, reduce costs, and improve transplant and cellular therapy outcomes.

Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma

The goal of this is Single-Arm, Multicenter, Open-Label Clinical Study is to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection(Axi-cel) as First-Line Therapy of High-Risk Large B-Cell Lymphoma.

Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies

Patients with refractory/relapse hematologic oncology disease may benefit from innovative therapy such as Car-T cells. Factors strongly predictive of outcome and response are unknown. Extracellular vesicles are recognized as a mode of intercellular communication and are reminiscent of the cell of origin. They are currently candidates to be biomarkers for this biomarker of phenomena occurring in tissues. The working hypothesis is that they may be predictive of outcome and toxicity, as some preliminary data have suggested. Therefore, the aim of the study concerns I dentification of potential CAR-EV biomarkers associated with neurological toxicity after infusion of CAR-T cells.

Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Children With Refractory Refractory AAV

This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-CD19 CAR-T cells in the treatment of childhood-onset refractory ANCA-Associated Vasculitis.

CAR-T Technology for Recurrent/Refractory Malignant Hematological and Lymphatic Tumors

evaluate the safety and Esfficacy of CAR-T technology for the treatment of recurrent/refractory malignant hematological lymphomas

GPC3/Mesothelin-CAR-γδT Cells Against Cancers

The third generation of GPC3/mesothelin targeted CAR-γδT cells have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-γδT cells for immunotherapy of human cancer patients with GPC3 or Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin-CAR-γδT cell immunotherapy on human cancers will firstly be evaluated.

Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers

The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.