• Active, not recruiting

NCT03548207: Phase 1b -2 - JNJ-68284528, CAR-T Therapy against BCMA in relapsed MM (CARTITUDE-1)

Updated: Oct 24

CARTITUDE-1

Ciltacabtagene Autoleucel

autologous bi-epitope BCMA-targeted CAR T cells

JNJ-68284528

LCAR-B38M

cilta-cel

CARTITUDE-1

The purpose of the study is to characterize safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of JNJ-68284528 (Phase 2).

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1)


Sponsor

Janssen Research & Development, LLC


Legend Biotech

 

ClinicalTrials.gov Identifier: NCT03548207

Official Title: A Phase 1b-2, Open-Label Study of JNJ-68284528, A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

First Posted : June 7, 2018

Click here to see details on ClinicalTrials.gov

 

CART - BCMA : National Cancer Institute


Ciltacabtagene Autoleucel

Ciltacabtagene Autoleucel (Code C148498)

Autologous Anti-BCMA CAR-T Cells JNJ-68284528

Autologous Bi-epitope BCMA-targeted CAR T-cells JNJ-68284528

Autologous Bi-epitope CAR T-cells JNJ-68284528

Cilta-cel

Ciltacabtagene Autoleucel

CILTACABTAGENE AUTOLEUCEL

JNJ-68284528

LCAR-B38M

LCAR-B38M-transduced Car-T Cells JNJ-68284528

LCAR-B38M-transduced CAR-T Cells JNJ-68284528

 

ASH 2020 Annual Meeting - CARTITUDE-1 Oral Presentation

177 CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma

62nd ASH Annual Meeting and Exposition

December 5-8, 2020

Click here for details

 

Meeting Abstract | 2021 ASCO Annual Meeting

Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1.

Click here for details

 

Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study

PMID: 34175021; Lancet ; July 2021

Click here for details

 

550 Ciltacabtagene Autoleucel for Triple-Class Exposed Multiple Myeloma: Adjusted Comparisons of CARTITUDE-1 Patient Outcomes Versus Therapies from Real-World Clinical Practice from the LocoMMotion Prospective Study

Program: Oral and Poster Abstracts

Type: Oral

Session: 704. Cellular Immunotherapies: Cellular Therapies for Myeloma

Hematology Disease Topics & Pathways:

Biological, Clinical Research, Plasma Cell Disorders, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Diseases, Real World Evidence, Therapies, Lymphoid Malignancies, Infusion

Sunday, December 12, 2021: 5:15 PM


Learn more

 

549 Updated Results from CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Patients With Relapsed/Refractory Multiple Myeloma

Program: Oral and Poster Abstracts

Type: Oral

Session: 704. Cellular Immunotherapies: Cellular Therapies for Myeloma

Hematology Disease Topics & Pathways:

Clinical Trials, Biological, Clinical Research, Plasma Cell Disorders, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Diseases, Therapies, Lymphoid Malignancies, Infusion

Sunday, December 12, 2021: 5:00 PM


Learn more

 

3938 Efficacy and Safety of Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 Subgroup Analysis

Program: Oral and Poster Abstracts

Session: 731. Autologous Transplantation: Clinical and Epidemiological: Poster III

Hematology Disease Topics & Pathways:

Biological, Clinical Trials, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Clinical Research, Plasma Cell Disorders, Diseases, Therapies, Infusion, Lymphoid Malignancies

Monday, December 13, 2021, 6:00 PM-8:00 PM


Learn more

 

2812 Anakinra Targeting Cytokine Release Syndrome Associated with Chimeric Antigen Receptor T-Cell Therapies

Program: Oral and Poster Abstracts

Session: 704. Cellular Immunotherapies: Clinical: Poster II

Hematology Disease Topics & Pathways:

Biological, Clinical Trials, Cytokine Release Syndrome, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Clinical Research, Plasma Cell Disorders, Clinically Relevant, Diseases, Therapies, Infusion, Lymphoid Malignancies, Adverse Events

Sunday, December 12, 2021, 6:00 PM-8:00 PM


Learn more

 

Neurocognitive and hypokinetic movement disorder with features of parkinsonism after BCMA-targeting CAR-T cell therapy - Nat Med; 2021 Dec

Learn more:

https://pubmed.ncbi.nlm.nih.gov/34893771/

 

RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.


Updated, longer-term results from the pivotal Phase 1b/2 CARTITUDE-1 study evaluating the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel) in heavily pre-treated patients who have relapsed and/or become refractory will be featured in an oral presentation (Abstract #549). Another oral presentation will report comparisons of patient outcomes with cilta-cel in the CARTITUDE-1 study with standard-of-care therapies from real-world clinical practice (Abstract #550).


Separately, data being presented as a poster presentation will highlight the potential use of anakinra as a treatment for cytokine release syndrome associated with CAR-T therapy treatment (Abstract #2812).


https://www.jnj.com/janssen-to-present-the-strength-and-promise-of-its-hematologic-malignancies-portfolio-and-pipeline-at-ash-2021

 

(11) Updated Results from CARTITUDE-1: Phase 1b/2Study of Cilta-Cel in Pts With RR Multiple Myeloma - YouTube

ASH 2021 - Dec 13, 2021

International Myeloma Foundation

Subscribe to our channel: https://www.youtube.com/c/IMFMyeloma

 

Ciltacabtagene Autoleucel, an Anti-B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up

J Clin Oncol;2022 Jun

Click here for details

 

(11) Updated Results (2 years post-LPI) in Phase 1b/2 (CARTITUDE-1) Study of Cilta-Cel in RRMM patients - YouTube

ASCO 2022 - Jun 29, 2022

International Myeloma Foundation

Subscribe to our channel: https://www.youtube.com/c/IMFMyeloma

 

- Arizona: Mayo Clinic Arizona

- California: University of California San Francisco

- California: City of Hope Duarte

- Illinois: University of Chicago

- Massachusetts: Massachusetts General Hospital Boston

- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston

- Michigan: Barbara Ann Karmanos Cancer Institute Detroit

- Minnesota: Mayo Clinic Rochester Minnesota

- Nebraska: University of Nebraska Medical Center Omaha

- New York: Memorial Sloan-Kettering Cancer Center New York

- New York: Tisch Cancer Institute Mount Sinai Hospital New York

- North Carolina: Levine Cancer Institute Charlotte

- Pennsylvania: University of Pennsylvania Philadelphia

- Pennsylvania: University of Pittsburgh Medical Center

- Tennessee: Sarah Cannon Research Institute Nashville

- Wisconsin: Froedtert Memorial Milwaukee

 

Locations

United States, Arizona

United States, California

United States, Illinois

United States, Massachusetts

United States, Michigan

United States, Minnesota

United States, Nebraska

United States, New York

United States, North Carolina

United States, Pennsylvania

United States, Tennessee

United States, Wisconsin

Asia

Japan

 

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