Clinical Studies for Cell Therapy

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Title: Assessing the Performance of “DCog Short”, an iPad-Based Tool for Neurotoxicity Evaluation in CAR-T Cell Therapy Patients: A Pilot Study
Brief Title: Assessing DCog Short for Neurotoxicity in CAR-T
Brief Summary: The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy.
For info regarding 25-610 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Randomized, Open-label Study Evaluating The Efficacy And Safety Of Cemacabtagene Ansegedleucel In Participants With Minimal Residual Disease After Response To First Line Therapy For Large B-cell Lymphoma (Alpha3)
Brief Title: Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Brief Summary: This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.
For info regarding 24-421 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Long-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel
Brief Title: LTFU for Ciltacel Treatment
For info regarding 22-145 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Phase II Multicenter Trial of anti-B Cell Maturation Antigen Chimeric Antigen Receptor T Cell Therapy for Multiple Myeloma Patients with Sub-Optimal Response After Autologous Hematopoietic Cell Transplantation and Maintenance Lenalidomide
Brief Title: Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma
Brief Summary: This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).
For info regarding 21-673 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELLNON-HODGKIN LYMPHOMA (NHL)
Brief Title: A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Brief Summary: This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This study is divided into three periods: - Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation; - Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29; - Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.
For info regarding 20-011 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Use of Miltenyi Biotec's CliniMACS CD34 Reagent System Under a Humanitarian Device Exemption for Isolation of Hematopoietic System Cells or T-Cell Depletion in Multiple Settings
Brief Title: CLINIMACS CD34 FOR HSC ISOLATION OR T-CELL DEPLETION
For info regarding 15-345 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu