Clinical Research Directory

A Study of Inotuzumab and Blinatumomab in People With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia

The purpose of this study is to find out whether combining inotuzumab and blinatumomab is a safe and effective treatment for participants with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL).

Autologous Bedside CD19 CAR T-cell Therapy for B-ALL

The purpose of this clinical trial is to learn if autologous bedside CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the autologous bedside CD19 CAR-T cell product. The main questions it aims to answer are: 1. What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and CAR-T-related adverse events (AEs) after the autologous CD19 CAR-T cell infusion for B-ALL? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)? Participants will: 1. Receive autologous bedside CD19 CAR T-cell therapy on Day 0. 2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 3. Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.

Allogeneic UCB-derived CAR-T for B-ALL

The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the allogeneic, umbilical cord blood-derived CAR-T cell product. The main questions it aims to answer are: 1. What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and UCAR-T-related adverse events (AEs) after the UCAR-T cell infusion? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)? Participants will: 1. May receive lymphodepletion chemotherapy if clinically indicated: fludarabine (30 mg/m²/d, days -5, -4, and -3) and cyclophosphamide (300-500 mg/m²/d, days -5 and -4). 2. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. 3. Receive UCAR-T cells infusion on Day 0. 4. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 5. Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after UCAR-T cells infusion, with continued long-term follow-up for safety and persistence.

Blinatumomab Combined With Venetoclax as Maintenance Therapy After Allo-HSCT in High-risk Ph Negative Acute B-cell Lymphoblastic Leukemia

This study is a single-center, single-arm, prospective clinical trial evaluating the efficacy and safety of blinatumomab combined with venetoclax as maintenance therapy for high-risk Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation .

Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of allogeneic CD19-targeted CAR-γδT Cell in treating CD19-positive relapsed/refractory B-ALL

CD19 Chimeric Antigen Receptor (CAR) T Cells for Adults With Recurrent or Refractory B Cell Malignancies

In this protocol, the investigators hypothesize that modifying the process of producing CAR+ T-cells can help to improve responses and reduce toxicities. Building on previous in vitro studies that have shown successful production of CAR+ T-cells using a new production approach, the investigators are now studying the ability to produce these CAR+ T-cells and determine how well they work in the clinical setting.