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NCT04155749: Phase 1 : CART-ddBCMA - Master Protocol for Cell Therapies in Multiple Myeloma

Updated: Aug 27, 2022

NCT04155749: Phase 1: Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma

cart ddBCMA

Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma


Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.


ARM 1 is a non-randomized, open label, multi-site Phase 1 study. CART-ddBCMA is a BCMA directed CAR with a non-scFv binding domain that has been deimmunized.

ARM 2 is a non-randomized, open label, multi-site Phase 1 study. Using the bivalent BCMA-Specific Adapter (SPRX001) and Universal CAR-Modified T cell (ARC-T Cells)


Sponsor

Arcellx, Inc


Multiple Locations

 

ClinicalTrials.gov Identifier: NCT04155749


Official Title: Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up


First Posted : November 7, 2019


Click here to see details on ClinicalTrials.gov

 

Drug: CART-ddBCMA

Drug: ARC-T Plus Anti-BCMA SparX

 

Anti-BCMA SparX Protein Plus BCMA-directed Anti-TAAG ARC T-cells CART-ddBCMA


Anti-BCMA SparX Protein Plus BCMA-directed Anti-TAAG ARC T-cells CART-ddBCMA (Code C167337)

Anti-BCMA SparX Protein Plus BCMA-directed Anti-TAAG ARC T-cells CART-ddBCMA

Anti-TAG ARC-T Cells Directed by BCMA Bi-valent/TAG SparX Protein

ARC-T Plus Anti-BCMA SparX

Immunotherapeutic Combination Agent SparX Protein Plus CART-ddBCMA

TAG-containing SparX /Bivalent BCMA-targeted ARC-T Cells

 

Meeting: 2022 ASCO Annual Meeting - Session Type: Oral Abstract Session - Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia - Track: Hematologic Malignancies - Sub Track: Hematologic Malignancies - Clinical Trial Registration Number: NCT04155749

Abstract#: 8003 - Phase 1 study of CART-ddBCMA in relapsed or refractory multiple myeloma.


Click here to read abstract details

 

ABSTRACTS & PRESENTATIONS

2022 ASCO ANNUAL MEETING - June 3-7, 2022 - McCormick Place, Chicago, IL - Hybrid Meeting

2022 ASCO Annual Meeting - Oral Abstract Session

Click here for details

 

Arcellx To Present New Clinical Data From Its CART-DdBCMA Phase 1 Trial In Patients With Relapsed Or Refractory Multiple Myeloma In An Oral Abstract Session At The 2022 American Society Of Clinical Oncology (ASCO) Annual Meeting

NEWS PROVIDED BY Arcellx, Inc Apr 27, 2022, 10:00 ET

FOSTER CITY, Calif., April 27, 2022 /PRNewswire/ -- Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that new clinical data from its Phase 1 Study of CART-ddBCMA in patients with relapsed or refractory multiple myeloma will be presented in an oral abstract session at the 2022 ASCO Annual Meeting taking place June 3-7, 2022, in Chicago, Illinois.


Click here for details

 

Research Article| April 25, 2022

Phase 1 Study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma

CART-ddBCMA are safe for use in patients with relapsed or refractory multiple myeloma

CART-ddBCMA produce deep and durable responses in patients with poor prognostic factors


Click here for details

 

3832 Phase 1 Study of CART-Ddbcma, a CAR-T Therapy Utilizing a Novel Synthetic Binding Domain for the Treatment of Subjects with Relapsed and /or Refractory Multiple Myeloma

Program: Oral and Poster Abstracts

Session: 704. Cellular Immunotherapies: Clinical: Poster III

Hematology Disease Topics & Pathways:

Clinical Trials, Biological, Cytokine Release Syndrome, Adults, Neurotoxicity, Clinical Research, Plasma Cell Disorders, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Elderly, Clinically Relevant, Diseases, Therapies, Immunotherapy, Lymphoid Malignancies, Adverse Events, Study Population

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


Click here for details

 

Arcellx Presents Continued Robust Long-Term Responses from its CART-ddBCMA Phase 1 Expansion Trial in Patients with Relapsed or Refractory Multiple Myeloma at the 63rd ASH Annual Meeting and Exposition


December 13, 2021 09:00 ET | Source: Arcellx, Inc.

FOSTER CITY, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Arcellx, Inc., a privately held clinical-stage biopharmaceutical company, today announced new positive clinical data from the ongoing Phase 1 expansion study of its novel, autologous, CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma. The clinical results are being presented at the 63rd American Society of Hematology Annual Meeting and Exposition.

Click here for details

 

Meeting Abstract | 2021 ASCO Annual Meeting I

Phase 1 Study of CART-ddBCMA, a CAR-T therapy utilizing a novel synthetic binding domain, for the treatment of subjects with relapsed and refractory multiple myeloma.

https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.8015

 

3199 Phase 1 Study of CART-Ddbcma, a CAR-T Therapy Utilizing a Novel Synthetic Binding Domain for the Treatment of Subjects with Relapsed and Refractory Multiple Myeloma

Program: Oral and Poster Abstracts

Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster III

Hematology Disease Topics & Pathways:

Biological, Adult, bioengineering, Therapies, CAR-Ts, Elderly, gene therapy, Technology and Procedures, immunotherapy, gene editing, Study Population, Clinically relevant

Monday, December 7, 2020, 7:00 AM-3:30 PM


https://ash.confex.com/ash/2020/webprogram/Paper142931.html

 

OAB-003 - Phase 1 study of CART-ddBCMA, a CAR-T therapy utilizing a novel synthetic binding domain for the treatment of subjects with relapsed and refractory multiple myeloma


#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California

IMS 2022 Abstract EBook

https://www.myelomasociety.org/


#IMS2022 - 19th International Myeloma Society Annual Meeting; Aug 25-27, LA California (themyelomaclinicaltrials.com)

 

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