Chimeric Antigen Receptor (CAR) T-Cell Therapy Clinical Trials at the Mario Lemieux Center for Blood Cancers

This study will enroll approximately 50 adult subjects who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.

Principal Investigator: Alison Sehgal, MD
Co-Investigators: Kathleen Dorritie, MD, Warren Shlomchik, MD
Sponsor: Kite, a Gilead Company

View eligibility criteria and the full trial at ClinicalTrials.gov.

This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety and antitumor activity. We will also determine how long the modified T cells stay in the patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma whose disease has come back or has not responded to treatment. Juno Therapeutics Inc. is the sponsor of this study.

Principal Investigator: Alison Sehgal, MD
Co-Investigators: Kathleen Dorritie, MD; Warren D. Shlomchik, MD

View eligibility criteria and the full trial description at ClinicalTrials.gov.

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 randomized part to assess JCAR017 monotherapy treatment versus standard of care. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

Principal Investigator: Kathleen Dorritie, MD
Sponsor: Juno Therapeutics, Inc.

View eligibility criteria and the full trial at ClinicalTrials.gov.

This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.

Principal Investigator: Alison Sehgal, MD

Sponsor: Juno Therapeutics, Inc.

View eligibility criteria and the full trial description at ClinicalTrials.gov.

The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.

Principal Investigator: Kathleen Dorritie, MD

Sponsor: Kite, A Gilead Company

View eligibility criteria and the full trial description at ClinicalTrials.gov.

This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM).

The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.

Principal Investigator: Mounzer E. Agha, MD
Sponsor: Celgene

View eligibility criteria and full trial description at clinicaltrials.gov.

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B).

All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT).

Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event.

Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.

Principal Investigator: Alison Sehgal, MD
Sponsor: Celgene

View eligibility criteria and the full trial description at ClinicalTrials.gov.