- Active, not recruiting
NCT03548207: Phase 1b -2 - JNJ-68284528, CAR-T Therapy against BCMA in relapsed MM (CARTITUDE-1)
Updated: Oct 24, 2022
CARTITUDE-1
Ciltacabtagene Autoleucel
autologous bi-epitope BCMA-targeted CAR T cells
JNJ-68284528
LCAR-B38M
cilta-cel
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
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
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
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.
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
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
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
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
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
Neurocognitive and hypokinetic movement disorder with features of parkinsonism after BCMA-targeting CAR-T cell therapy - Nat Med; 2021 Dec
Learn more:
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).
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
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
RELATED POSTS
NCT04133636: CARTITUDE-2 - Phase 2 study of JNJ-68284528, CAR-T Therapy Directed Against BCMA in MM
A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma
NCT04181827: CARTITUDE 4 - Phase 3 -Cilta-cel vs Pom/Bort/Dex or Dara/Pom/Dex in relapsed len ref RRMM
A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma
NCT04923893: CARTITUDE-5 - Phase 3 - VRd f/by Cilta-cel Vs VRd f/b Rd - NDMM- (No ASCT planned)
A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
NCT05257083: CARTITUDE-6 - Phase 3: EMN 28 - DVRd -> Cilta-Cel (CART) Vs DVRd -> Transplant ASCT NDMM
A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible