Clinical Studies for Cell Therapy

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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: EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE
Brief Title: Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Brief Summary: This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel. Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting.
For info regarding 21-072 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