Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Venetoclax

Tin Fluorides

Ibrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)

Subjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm + ibrutinib

Subjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm

Subjects will receive venetoclax as bridging anticancer therapy until lymphodepletion chemotherapy/ JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm. After JCAR017 infusion subjects will receive venetoclax until Day 90.

Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.

JCAR017 (lisocabtagene maraleucel)

Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.

JCAR017 (lisocabtagene maraleucel) + ibrutinib

Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.

JCAR017 (lisocabtagene maraleucel) + venetoclax

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain the NCT# and Site #.

Tiffany Hill

Danielle Mussey

Amitkumar Mehta, MD

Brenda Noggy

Rajneesh Nath, MD

Hormoz Mirshkarlo, MD

Tanya Siddiqi, MD

Krisma C Montalvo

Kimberly Aguilar

Thomas J Kipps, MD, PhD

Joy Valadez

Anna Crosetti

Herbert Eradat, MD, MS

Andrew Chon

Lawrence Kaplan, MD

Pari Ramzi

Pashna Munshi, MD

Mohamed Kharfan-Dabaja, MD

Teresa Banda

Scott R Solomon, MD

Stacey Brown

Study Coordinator

Arezou Ireta

Shuo Ma, MD, PhD

Sadi Dixon, RN

Elaine Hoekstra

Peter Riedell, MD

Jacob D Soumerai, MD

Emma Logan, RN

Pavania Elavalakanar

Jon Arnason, MD

U of M Cancer Answerline

Monalisa Ghosh, MD

Joo En Kim, MPH

Abhinav Deol, MD

Clinical Trials Referral Office

Gabrielle Bouska

Saad Kenderian, MB, ChB

Gail A Paulsen

Lindsay Hicks

Julie Vose, MD

Kara Yannotti, RNC

Tatyana Feldman, MD

Oona Harrigan

Roger Strair, MD, PhD

June Greenburg

Koen Van Besien

Koen Van Besien, MD, PhD

Danielle Brander, Site 0030

Rachel Stowe

Danielle M Brander, MD

Paolo Caimi, MD

Yeritza Hernandez-Collazo, MS

Site 0031

Adam Asch, MD

Stephen Schuster, MD

Allison Scott

Matthew Carabasi, MD

Linda Fukas

Kathleen Dorritie, MD

Houston E Holmes III, MD, FACP

Courtney Saltarski

Farrukh Awan, MD

William G Wierda, MD, PhD

Kolleen Hicks, BS

Deborah Stephens, DO

SCCA Immunotherapy Trials Intake

David Maloney, MD, PhD

Nirav Shah, MD

Bristol-Myers Squibb

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 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

Phase 1: subjects will be assigned to receive JCAR017, or JCAR017 + ibrutinib Phase 2: subjects will be assigned to receive JCAR017 at the recommended dose

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

Proportion of subjects experiencing adverse events

Proportion of subjects experiencing laboratory abnormalities

Proportion of subjects who have CR after treatment with JCAR017 + ibrutinib using iwCLL 2018 guidelines

Proportion of subjects who have CR after treatment with JCAR017 + venetoclax using iwCLL 2018 guidelines

Proportion of subjects who have CR after treatment with JCAR017 using iwCLL 2018 guidelines

Defined as the rate of CR (including CRi)

Proportion of subjects who achieve MRD CR

Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause

Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause

Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR

Defined as the interval from JCAR017 infusion to the first documentation of CR

Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause

Defined as the time from JCAR017 infusion to the date of death due to any cause

Proportion of subject experiencing adverse events

Change from baseline in HRQoL assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

Change from baseline in HRQoL assessed using the EORTC chronic lymphocytic leukemia (CLL)-specific module QLQ-CLL-17

Change from baseline in measurement of health utility values using EuroQol instrument EQ-5D-5L

Proportion of participants with intensive care unit (ICU) inpatient days

Proportion of participants with non-ICU inpatient days

Spots Global Cancer Trial Database for jcar017 (lisocabtagene maraleucel)