Clinical Research Directory

Allogeneic iNKT Cell Therapy (agenT-797) After SCT

The goal of this clinical trial is to learn if agenT-797 is safe to use on people undergoing allogenic hematological stem cell transplantation (SCT). The main questions it aims to answer are: * Is agenT-797 safe to use? * What medical problems do participants have when taking agenT-797? Participants will receive an infusion of agenT-797 about 7 days after their allogenic SCT.

Phase I Safety Clinical Trial of Anti-CD19 CAR-T Therapy COL01 for the Treatment of Adults With Relapsed or Refractory B-cell Lymphoid Neoplasms: First-in-human Administration, COLIBRI.

The objective of this Phase I clinical trial is to evaluate the safety, toxicity profile, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of autologous CAR-T anti-CD19 cell therapy (CAR-T ANTI-CD19 COL01) in adult participants (aged 18 years and older) with relapsed or refractory CD19-positive B-cell lymphoid malignancies (including diffuse large B-cell lymphoma \[DLBCL\], mantle cell lymphoma \[MCL\], follicular lymphoma \[FL\], and precursor B-cell acute lymphoblastic leukemia \[B-ALL\]) after at least two prior lines of systemic treatment. The primary questions this study aims to answer are: What is the safety and toxicity profile, including the incidence and severity of adverse events (such as Cytokine Release Syndrome \[CRS\], Immune Effector Cell-Associated Neurotoxicity Syndrome \[ICANS\]), and dose-limiting toxicities (DLTs) associated with CAR-T ANTI-CD19 COL01? What is the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CAR-T ANTI-CD19 COL01 for future clinical studies? Comparison Group: This is a single-arm, non-comparative Phase I study; there is no comparison or control group. All enrolled participants receive the investigational CAR-T ANTI-CD19 COL01 therapy. Participants will be asked to: Undergo screening procedures and baseline diagnostic assessments to determine eligibility. Undergo leukapheresis for peripheral blood T-cell collection to manufacture the autologous CAR-T cell product. Receive a lymphodepleting conditioning chemotherapy regimen prior to product administration. Receive a single intravenous infusion of CAR-T ANTI-CD19 COL01 cells. Complete mandatory post-infusion monitoring (inpatient and outpatient surveillance), safety checks, blood sampling, and clinical disease response evaluations (including imaging and/or bone marrow examinations).

Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies

This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate are in patients with lymphoid malignancies and to determine the dose of the combination of drugs that is safest. If the combination is determined to be safe, the study will continue accrual patients with peripheral T-Cell lymphoma (PTCL).

The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies

This is an open-label, Phase 1/2 study designed to characterize the safety, tolerability, Pharmacokinetics(PK), and preliminary antitumor activity of AVM0703 administered as a single intravenous (IV) infusion to patients with lymphoid malignancies.

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.