Roles
- Professor of Clinical Medicine
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Biography
Dr. Lekakis is a Professor of Medicine who joined the University of Miami in 2010 and became an attending physician for Hemotology/Oncology and Blood and Marrow Transplantation in 2012. He has since started the CAR-T trials, performed the first CAR-T for solid tumors, and transplanted adult sickle cell disease patients. Dr. Lekakis is a member of the USA CAR-T Consortium and several CIBMTR committees including CAR-T, Lymphoma, Leukemia, and GVHD. His main interests are CAR-T and GVHD. -
Education & Training
Education
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Publications
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Clinical Trials
Viewing 0 of 19 clinical trials.
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A Phase 2 Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 2
- Enrollment Status: Closed
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A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 2
- Enrollment Status: Closed
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A Multicenter, Open-label, Expanded Access Study of Axicabtagene Ciloleucel for the Treatment of Subjects With Relapsed/Refractory Large B-cell Lymphoma.
- Principal Investigator: Lazaros Lekakis
- Study Phase: N/A
- Enrollment Status: Closed
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A Single Arm, Open-label, Multi-centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 With Anti PD1 Antibody in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 1/Phase 2
- Enrollment Status: Closed
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An Open Label Phase 2, Study to Evaluate the Safety and Efficacy of RGI-2001 for the Prevention of Acute Graft-vs-Host Disease Compared to Contemporary Controls in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 2
- Enrollment Status: Closed
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A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 1/Phase 2
- Enrollment Status: Closed
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The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase I/II
- Enrollment Status: Closed
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A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 2
- Enrollment Status: Closed
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ML43165 - Single Arm Phase 2 Trial of an FDA Approved Anti-CD19 CAR-T Therapy Followed by Mosunetuzumab and Polatuzumab Consolidation for the Treatment of Refractory/Relapsed Aggressive NHL.
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 2
- Enrollment Status: Open
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A Study to Compare Bone Marrow Transplantation to Standard Care in Adolescents and Young Adults With Severe Sickle Cell Disease (BMT CTN 1503)
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 2
- Enrollment Status: Closed
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A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Recurrent, Metastatic or Persistent Cervical Carcinoma
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 2
- Enrollment Status: Closed
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A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 3
- Enrollment Status: Closed
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This study is designed to help us learn whether the study treatment, CC-97540 (BMS-986353), works to treat Systemic Lupus Erythematosus (SLE).
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase II
- Enrollment Status: Not Accepting
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Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase I/II
- Enrollment Status: Closed
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A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase 2
- Enrollment Status: Closed
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All patients who have participated in a Sponsor-supported GM T-cell research study (this is called the treatment study), and have received treatment with GM T cells, will be asked to participate in this long-term follow-up study to be monitored for delayed side effects
- Principal Investigator: Lazaros Lekakis
- Study Phase: N/A
- Enrollment Status: Open
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- To evaluate the safety and tolerability of CC-97540 in participants with severe, refractory SLE, IIM, or SSc.- To determine the RP2D of CC-97540 in participants with severe, refractory SLE, IIM, SSc or RA
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase I
- Enrollment Status: Not Accepting
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The purpose of this study is to test the safety of TC-510 at different doses to find out what effects, if any, it has on patients with mesothelioma (a tumor of the tissue that lines the lungs, stomach, heart, and other organs), ovarian cancer (cancer of the ovaries), pancreatic cancer (cancer of the pancreas), triple negative breast cancer, or colorectal cancer (cancer of the colon or rectum).
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase I/II
- Enrollment Status: Closed
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This study will collect important information about any long-term side-effects you experience for up to 15 years after you received Autolus CAR T cell therapy.It will also measure if you still have any Autolus CAR T cells in your blood, the presence of the virus used to make the Autolus CAR T cells in your blood, the long-term effectiveness of the Autolus CAR T cell therapy and collect information about any continuous supportive care and other anti-cancer treatments you may have after your Autolus CAR T cell therapy. The results may be used to further improve the safety and effectiveness of Autolus CAR T cell therapies in future patients.
- Principal Investigator: Lazaros Lekakis
- Study Phase: Phase II
- Enrollment Status: Not Accepting