CAR T-Cell Research and Clinical Trials

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. Kite, a Gilead Company, 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 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 study will determine the safety and efficacy of JCAR017, a therapy that uses a patient’s own T-cells to fight cancer, in adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The goal of this study is to determine the effect of JCAR017 and the recommended dose schedule.

Phase one of this study will determine the recommended dose of JCAR017 monotherapy. The randomized Phase 2 portion will assess JCAR017 monotherapy treatment versus standard of care (SOC), with the possibility of crossover in patients on the SOC arm. Juno Therapeutics is the sponsor of this study.

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

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.