Multiple Myeloma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

March 12 15:52 2025
Multiple Myeloma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Multiple Myeloma Pipeline Insights” report provides comprehensive insights about 75+ Multiple Myeloma Companies and 80+ pipeline drugs in the Multiple Myeloma pipeline landscape. It covers the Multiple Myeloma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Multiple Myeloma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Multiple Myeloma Pipeline Report

  • In March 2025:- Kite, A Gilead Company conducted a study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug.
  • In March 2025:- GlaxoSmithKline announced a study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Chinese participants with relapsed/refractory multiple myeloma.
  • In March 2025:- AbbVie conducted a study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study).
  • In March 2025:- Pfizer announced a study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).
  • DelveInsight’s Multiple Myeloma pipeline report depicts a robust space with 75+ Multiple Myeloma companies working to develop 80+ pipeline therapies for Multiple Myeloma treatment.
  • The leading Multiple Myeloma Companies such as CASI Pharmaceuticals, Carsgen Therapeutics, Cartesian Therapeutics, Gracell Biotechnology Shanghai Co., Ltd., Sorrento Therapeutics, TeneoOne, Karyopharma Therapeutics, Arcellx, Poseida Therapeutics, Ichnos Sciences, Nerviano Medical Sciences, Bristol Myers Squib, Ascentage Pharma, Ionis Pharmaceuticals, Chongqing Precision Biotech Co., Ltd., CRISPR Therapeutics, AstraZeneca, IGM Biosciences, Novartis, GlaxoSmithKline, Innovent Biologics, Keymed Biociences, Starton Therapeutics, Takeda, Fate Therapeutics, Gilead Sciences, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., Janssen Pharmaceutical, Nanjing IASO Biotechnology Co., Ltd., GPCR Therapeutics, Chimerix, and others.
  • Promising Multiple Myeloma Pipeline Therapies such as TNB-383B, belantamab mafodotin, Pembrolizumab, Melphalan flufenamide (Melflufen), Dexamethasone, Pomalidomide, Venetoclax, Bortezomib, BT062, Selinexor, Lenalidomide, Methylprednisolone, and others.

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Multiple myeloma Emerging Drugs Profile

  • Zevorcabtagene Autoleucel: Carsgen Therapeutics

Zevorcabtagene Autoleucel (Zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product candidate against B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma (R/R MM). In October 2022, China National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) and has granted the priority review for zevor-cel. Zevor-cel is expected to be approved by the NMPA for the treatment of R/R MM at the end of 2023 or the beginning of 2024. In January 2023, CARsgen and Huadong Medicine entered into a collaboration agreement for the commercialization of CARsgen’s lead drug candidate, zevor-cel, in mainland China. Since reaching the agreement, teams from CARsgen and Huadong Medicine have been working together closely to implement this collaboration and prepare for the approval and commercialization of zevor-cel in China.

  • Descartes 08: Cartesian Therapeutics

Descartes-08 is an autologous BCMA-targeting RNA-modified CAR T-cell therapy. Descartes-08 is engineered by mRNA transfection to express anti-BCMA CAR for a defined length of time. Descartes-08 express anti-BCMA CAR for 1 week, limiting risk of uncontrolled proliferation; produce inflammatory cytokines in response to myeloma target cells; and are highly cytolytic against myeloma cells regardless of presence of myeloma-protecting bone marrow stromal cells, exogenous a proliferation-inducing ligand, or drug resistance including IMiDs. The magnitude of cytolysis correlates with anti-BCMA CAR expression duration, indicating a temporal limit in activity. In early-stage clinical studies, Descartes-08 has been safe and well-tolerated in patients with MG and multiple myeloma. Currently, the drug is in the Phase II stage of its development for the treatment of Multiple Myeloma.

  • GC012F: Gracell Biotechnology Shanghai Co., Ltd.

GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with improved safety profile. GC012F is currently being evaluated in clinical studies in multiple hematological cancers as well as autoimmune diseases, and has demonstrated a consistently strong efficacy and safety profile. Gracell has initiated a Phase 1b/2 trial evaluating GC012F for the treatment of relapsed/refractory multiple myeloma in the United States and a Phase 1/2 clinical trial in China is to be commenced imminently.

  • CID-103: CASI Pharmaceuticals

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope on CD38. It was engineered to have strong activity against CD38 malignant cells and to reduce certain safety issues observed with existing treatments. Preclinical data of CID-103 demonstrates enhanced activity against a broad array of malignancies which express CD38 and demonstrates a better preclinical safety profile when compared to other CD38 mAbs. These attributes offer the potential for accelerated development and regulatory review, including rapid advancement into earlier lines of therapy. Currently, the drug is in the Phase I stage of its development for the treatment of Multiple Myeloma.

  • STI-1492: Sorrento Therapeutics

STI-1492 is a therapeutic candidate developed by Sorrento Therapeutics for the treatment of relapsed or refractory multiple myeloma. It is an allogeneic, off-the-shelf therapy that involves the administration of Anti-CD38 A2 Dimeric Antigen Receptor T (DAR-T) cells through a single intravenous infusion. The therapy is currently being evaluated in a phase 1b, open-label, dose-escalation study involving subjects with relapsed or refractory multiple myeloma. CD38 is a transmembrane glycoprotein present on various immune cells and hematologic malignancies, and its expression has been associated with poor prognosis. Currently, the drug is in the Phase I stage of its development for the treatment of Multiple Myeloma.

The Multiple Myeloma Pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Multiple Myeloma with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Multiple Myeloma Treatment.
  • Multiple Myeloma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Multiple Myeloma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Multiple Myeloma market

Stay informed about the Multiple Myeloma pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Multiple Myeloma Unmet Needs

Multiple Myeloma Companies

CASI Pharmaceuticals, Carsgen Therapeutics, Cartesian Therapeutics, Gracell Biotechnology Shanghai Co., Ltd., Sorrento Therapeutics, TeneoOne, Karyopharma Therapeutics, Arcellx, Poseida Therapeutics, Ichnos Sciences, Nerviano Medical Sciences, Bristol Myers Squib, Ascentage Pharma, Ionis Pharmaceuticals, Chongqing Precision Biotech Co., Ltd., CRISPR Therapeutics, AstraZeneca, IGM Biosciences, Novartis, GlaxoSmithKline, Innovent Biologics, Keymed Biociences, Starton Therapeutics, Takeda, Fate Therapeutics, Gilead Sciences, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., Janssen Pharmaceutical, Nanjing IASO Biotechnology Co., Ltd., GPCR Therapeutics, Chimerix and others.

Multiple myeloma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Oral
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical

Multiple Myeloma Products have been categorized under various Molecule types such as

  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy

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Scope of the Multiple Myeloma Pipeline Report

  • Coverage- Global
  • Multiple Myeloma Companies- CASI Pharmaceuticals, Carsgen Therapeutics, Cartesian Therapeutics, Gracell Biotechnology Shanghai Co., Ltd., Sorrento Therapeutics, TeneoOne, Karyopharma Therapeutics, Arcellx, Poseida Therapeutics, Ichnos Sciences, Nerviano Medical Sciences, Bristol Myers Squib, Ascentage Pharma, Ionis Pharmaceuticals, Chongqing Precision Biotech Co., Ltd., CRISPR Therapeutics, AstraZeneca, IGM Biosciences, Novartis, GlaxoSmithKline, Innovent Biologics, Keymed Biociences, Starton Therapeutics, Takeda, Fate Therapeutics, Gilead Sciences, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., Janssen Pharmaceutical, Nanjing IASO Biotechnology Co., Ltd., GPCR Therapeutics, Chimerix, and others.
  • Multiple Myeloma Pipeline Therapies- TNB-383B, belantamab mafodotin, Pembrolizumab, Melphalan flufenamide (Melflufen), Dexamethasone, Pomalidomide, Venetoclax, Bortezomib, BT062, Selinexor, Lenalidomide, Methylprednisolone, and others.
  • Multiple Myeloma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Multiple Myeloma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

  1. Introduction
  2. Executive Summary
  3. Multiple myeloma: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Multiple myeloma– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Venetoclax: AbbVie
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. PHE885: Novartis
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I/II)
  14. ONC 201: Oncoceutics
  15. Drug profiles in the detailed report…..
  16. Early Stage Products (Phase I)
  17. TNB 383B: TeneoBio
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Multiple myeloma Key Companies
  21. Multiple myeloma Key Products
  22. Multiple myeloma- Unmet Needs
  23. Multiple myeloma- Market Drivers and Barriers
  24. Multiple myeloma- Future Perspectives and Conclusion
  25. Multiple myeloma Analyst Views
  26. Multiple myeloma Key Companies
  27. Appendix

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