MedPath

Clinical Trial News

Bispecific Antibodies Teclistamab and Talquetamab Show Promise in Multiple Myeloma Treatment

  • Teclistamab and talquetamab, bispecific antibodies, demonstrate efficacy in relapsed/refractory multiple myeloma by reducing soluble BCMA levels in responding patients.
  • A reduction in sBCMA levels correlates with the depth of treatment response, with complete or stringent complete responses showing nearly 100% sBCMA reduction.
  • Baseline sBCMA levels correlate with tumor burden, suggesting sBCMA as a potential marker, and do not significantly affect teclistamab exposure, indicating maintained clinical activity.
  • Clinical trials are underway to evaluate bispecific antibodies in earlier lines of therapy and maintenance settings, potentially transforming myeloma treatment.

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

NCT03145181Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/16/2017

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

NCT03548207CompletedPhase 1
Janssen Research & Development, LLC
Posted 6/29/2018

A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04910568Active, Not RecruitingPhase 1
Genentech, Inc.
Posted 7/26/2021

MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma

NCT04798586Unknown StatusPhase 1
Pfizer
Posted 3/22/2021

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

NCT05243797RecruitingPhase 3
Stichting European Myeloma Network
Posted 9/8/2022

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

NCT03710603Active, Not RecruitingPhase 3
Stichting European Myeloma Network
Posted 12/14/2018

A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma

NCT04674813Active, Not RecruitingPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 2/24/2021

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT04246047Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 5/7/2020

Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

NCT03651128Active, Not RecruitingPhase 3
Celgene
Posted 4/16/2019

Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years

NCT01191060CompletedPhase 3
University Hospital, Toulouse
Posted 10/1/2010

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04586426Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/15/2020

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347Active, Not RecruitingPhase 1
Genmab
Posted 11/3/2020

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

NCT04162210Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 4/2/2020

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04557098Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/17/2020

A clinical trial for patients with relapsed or refractory multiple myeloma, using an experimental drug called ISB 2001 for the first time in humans

2023-507071-21-01Not Yet RecruitingPhase 1
Ichnos Sciences S.A.

PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma

NCT03269136CompletedPhase 1
Pfizer
Posted 11/29/2017

Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)

NCT05396885Active, Not RecruitingPhase 2
Kite, A Gilead Company
Posted 8/9/2022

A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma

NCT05461209WithdrawnPhase 3
Janssen Research & Development, LLC
Posted 10/20/2022

Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma

NCT02874742CompletedPhase 2
Janssen Research & Development, LLC
Posted 8/29/2016

A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment

NCT04035226Completed
Janssen-Cilag Ltd.
Posted 8/2/2019

A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

NCT03319667Active, Not RecruitingPhase 3
Sanofi
Posted 12/7/2017

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

NCT05652335RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/22/2022

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

NCT04133636RecruitingPhase 2
Janssen Research & Development, LLC
Posted 11/7/2019

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

NCT04108195Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 2/21/2020

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 10/1/2020

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

NCT04722146Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 3/12/2021

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT04975997Active, Not RecruitingPhase 3
Celgene
Posted 6/23/2022

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

NCT02252172CompletedPhase 3
Janssen Research & Development, LLC
Posted 2/16/2015

A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

NCT05020236RecruitingPhase 3
Pfizer
Posted 10/4/2021

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04634552RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/1/2021

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

NCT05317416RecruitingPhase 3
Pfizer
Posted 3/25/2022

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

NCT06283719RecruitingPhase 1
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Posted 9/2/2024

A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment

NCT05014412Active, Not RecruitingPhase 2
Pfizer
Posted 10/7/2021

A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

NCT05050097Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/22/2021

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

NCT05552222RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/25/2022

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.

NCT06440057RecruitingPhase 1
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Posted 8/29/2024

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

NCT06208150RecruitingPhase 3
Janssen Research & Development, LLC
Posted 1/22/2024

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

NCT05083169Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/14/2021

MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

NCT04649359Active, Not RecruitingPhase 2
Pfizer
Posted 2/2/2021

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

NCT04181827Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 6/12/2020

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

NCT06413498RecruitingPhase 3
Kite, A Gilead Company
Posted 8/23/2024

Bayer Seeks Expanded Approval for Darolutamide in Japan and China for Metastatic Hormone-Sensitive Prostate Cancer

  • Bayer has submitted applications in Japan and China for darolutamide, seeking approval for metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (ADT).
  • The submissions are based on the Phase III ARASENS trial, which demonstrated a statistically significant improvement in overall survival for darolutamide plus ADT and docetaxel in mHSPC patients.
  • Darolutamide, marketed as Nubeqa™, is already approved in multiple markets, including the U.S., EU, Japan, and China, for non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis.
  • Prostate cancer is a significant health concern in both Japan and China, with a substantial proportion of patients experiencing disease progression, highlighting the need for new treatment options.

Next-Generation RNA Technologies Promise Longer-Lasting Therapeutics Beyond mRNA

• Biotech companies are developing novel RNA technologies, including circular RNA and transfer RNA, to overcome the rapid degradation limitations of current mRNA therapeutics.
• At least nine biotechnology startups have secured hundreds of millions in funding, with companies like Orna Therapeutics and Laronde leading circular RNA development with over $800M combined funding.
• These next-generation RNA platforms aim to enable longer-lasting protein expression, reduced dosing frequency, and expanded therapeutic applications across cancer, rare diseases, and chronic conditions.

Celltrion Pursues Adalimumab Interchangeability as Formycon Reports Positive Ustekinumab Biosimilar Data

  • Celltrion Healthcare has filed an investigational new drug application with the FDA for a Phase 3 clinical trial to establish interchangeability of its adalimumab biosimilar, Yuflyma, with Humira.
  • The Phase 3 trial will involve switching patients between Humira and Yuflyma to verify pharmacokinetics, efficacy, and safety in 366 patients with plaque psoriasis.
  • Formycon announced positive Phase 3 data for its ustekinumab biosimilar (FYB202), demonstrating comparable efficacy and safety to Stelara in patients with moderate to severe plaque psoriasis.
  • The Formycon study met its primary endpoint, showing comparable improvement in Psoriasis Area and Severity Index scores after 12 weeks, with no clinically meaningful differences in adverse events.

Cambridge Researchers Successfully Convert Kidney Blood Types to Universal O, Potentially Expanding Transplant Access

  • University of Cambridge researchers successfully converted three donor kidneys from blood type B to universal type O using an enzyme-based perfusion technique that removes blood type markers from organ vessels.
  • The breakthrough could significantly increase kidney transplant availability, particularly benefiting minority ethnic groups who face longer wait times due to blood type compatibility issues and lower donation rates.
  • The conversion process takes only a few hours using a normothermic perfusion machine, with researchers now testing how the modified kidneys react to different blood types before clinical trials.
  • Current data shows minority ethnic patients comprise 33% of the kidney transplant waiting list but only 9% of organ donations come from these communities, highlighting the potential impact of this technology.

FDA Approves Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes

The FDA has approved Inqovi™, an oral fixed-dose combination of decitabine and cedazuridine, for the treatment of adult patients with myelodysplastic syndromes (MDS). This approval is based on clinical trials demonstrating the drug's effectiveness and safety, offering a new oral treatment option for MDS patients.

Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML

NCT03306264CompletedPhase 3
Astex Pharmaceuticals, Inc.
Posted 2/15/2018

Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)

NCT02103478CompletedPhase 1
Astex Pharmaceuticals, Inc.
Posted 10/28/2014

Pfizer and Valneva's Lyme Disease Vaccine Candidate Enters Phase 3 Trial

• Pfizer and Valneva have initiated a Phase 3 clinical trial for their Lyme disease vaccine candidate, VLA15, in areas highly endemic for the disease. • The VLA15 vaccine aims to protect individuals as young as five years old and targets an outer surface protein of the Borrelia bacteria. • This trial includes approximately 6,000 participants in the U.S. and Europe and could lead to regulatory authorization as early as 2025. • The vaccine is similar to the previous LYMERix vaccine but omits a protein region that some attributed to adverse events.

Metformin Trial Targeting Aging Awaits Funding Despite Billionaire Interest in Longevity

• The TAME trial aims to demonstrate that metformin, a drug approved for diabetes, can delay multiple age-related diseases like cardiovascular disease, cancer, and cognitive decline. • Nir Barzilai's TAME trial received FDA agreement in 2015 but has struggled to secure the $30-50 million needed, as philanthropists favor 'moonshot' projects over repurposing generic drugs. • Experts believe the TAME trial could establish a framework for biotech companies, proving that targeting aging is a viable strategy for preventing multiple diseases simultaneously. • Barzilai is now seeking funding from crypto-millionaires and Hevolution, hoping to launch the trial and establish aging as an indication for drug approval.

Tagrisso Plus Savolitinib Shows Promising 49% Response Rate in EGFR-Mutated Lung Cancer with MET Resistance

Targeted TherapyOncologyPrecision Medicine
• Preliminary results from the SAVANNAH Phase II trial demonstrated that Tagrisso (osimertinib) plus savolitinib achieved a 49% objective response rate in EGFR-mutated NSCLC patients with high levels of MET overexpression who progressed on Tagrisso.
• MET was identified as the most common resistance biomarker in EGFR-mutated lung cancer, with 62% of patients screened showing MET overexpression and/or amplification after progression on Tagrisso.
• The combination therapy showed the highest response rate (52%) in patients with high MET levels who had not received prior chemotherapy, potentially offering a less toxic alternative to the current standard of chemotherapy after targeted therapy failure.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.