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Clinical Trial News

CAR-NK Cell Therapy Shows Promise as Safer Alternative to CAR-T with Comparable Efficacy in Early Clinical Trials

  • CAR-NK cell therapy demonstrates comparable efficacy to CAR-T cells with significantly improved safety profiles, showing no cases of graft-versus-host disease, cytokine release syndrome, or neurotoxicity in early clinical trials.
  • Clinical studies reveal promising response rates, with anti-CD19 CAR-NK cells achieving 73% objective responses in relapsed/refractory B-cell malignancies and anti-NKG2D CAR-NK cells showing 67% complete response rates in acute myeloid leukemia.
  • Multiple engineering strategies are advancing CAR-NK cell therapy, including dual-targeting constructs, iPSC-derived cells, and combination approaches that could enable off-the-shelf treatment options for broader patient populations.

Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma

NCT06066359RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 11/30/2023

Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL

NCT05883449TerminatedPhase 2
Affimed GmbH
Posted 10/10/2023

First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

NCT05086315TerminatedPhase 1
Sanofi
Posted 12/8/2021

FT576 in Subjects With Multiple Myeloma

NCT05182073Active, Not RecruitingPhase 1
Fate Therapeutics
Posted 11/10/2021

Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitoneally for the Management of Platinum Resistant Ovarian Cancer, Mesonephric-like Adenocarcinoma, and Pancreatic Cancer

NCT05922930RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 10/11/2023

A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)

NCT05834244RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 10/26/2023

Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1

NCT06083883RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 3/27/2024

Umbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells for B Lymphoid Malignancies

NCT03056339CompletedPhase 1
M.D. Anderson Cancer Center
Posted 6/21/2017

Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas

NCT04074746Active, Not RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 7/18/2020

Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors (TROPIKANA)

NCT06066424RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 10/24/2023

Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances

NCT05092451RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 11/1/2022

Phase I CB-NK-TGF-ßR2-/NR3C1- in rGBM

NCT04991870RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 4/28/2023

NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS

NCT04623944Active, Not RecruitingPhase 1
Nkarta, Inc.
Posted 9/21/2020

Advancing Cancer Treatment: The Promise of Oncolytic Virotherapy Combinations

  • Oncolytic viruses (OVs) selectively replicate within tumor cells, causing direct cell lysis while simultaneously triggering immune responses against cancer, offering a dual mechanism of action against malignancies.
  • While OV monotherapy has shown limited efficacy in clinical trials, combining oncolytic viruses with other treatment modalities such as immune checkpoint inhibitors, chemotherapy, and cell therapies has demonstrated synergistic anti-tumor effects.
  • Recent advances in engineering oncolytic vaccinia viruses to express immunomodulatory factors, including cytokines and antibodies targeting immune checkpoints, have shown promising results in remodeling the tumor microenvironment and enhancing therapeutic outcomes.

FDA Grants Full Approval to Elahere for Platinum-Resistant Ovarian Cancer

  • The FDA has granted full approval to mirvetuximab soravtansine-gynx (Elahere) for advanced, platinum-resistant ovarian cancer with FR-α overexpression.
  • The approval was based on the MIRASOL trial, which demonstrated improved overall and progression-free survival compared to standard chemotherapy.
  • Elahere, an antibody-drug conjugate, targets FR-α on cancer cells, delivering a cytotoxic drug while sparing healthy cells, reducing severe side effects.
  • Testing tumors for FR-α is now crucial to identify patients who can benefit from Elahere, marking a significant advancement in ovarian cancer treatment.

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

NCT04209855CompletedPhase 3
AbbVie
Posted 12/31/2019

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

NCT05445778RecruitingPhase 3
AbbVie
Posted 12/27/2022

Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer

NCT03878849RecruitingPhase 2
Allarity Therapeutics
Posted 4/15/2019

A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

NCT04296890CompletedPhase 3
ImmunoGen, Inc.
Posted 7/23/2020

Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO)

NCT05041257CompletedPhase 2
AbbVie
Posted 8/31/2021

Medicare Expands Coverage for Wegovy to Include Cardiovascular Risk Reduction

  • The FDA approved Wegovy (semaglutide) for reducing the risk of heart attacks and stroke in overweight or obese individuals with cardiovascular disease, opening the door for Medicare coverage.
  • An estimated 3.6 million Medicare beneficiaries (7%) with established cardiovascular disease and obesity or overweight could be eligible for Wegovy under this expanded indication.
  • Medicare Part D plans can now include Wegovy in their formularies, although coverage may vary, and out-of-pocket costs could range from $325 to $430 monthly.
  • Broader Medicare coverage of GLP-1s like Wegovy for various approved uses could influence the cost of legislation aimed at lifting the ban on Medicare coverage for anti-obesity drugs.

Immutep Announces Positive Preliminary Topline Results from TACTI-003 Cohort B

Immutep Limited has revealed encouraging preliminary topline results from Cohort B of the TACTI-003 Phase IIb trial, showing a 26.9% response rate in first-line head and neck squamous cell carcinoma patients with negative PD-L1 expression. The study evaluates the combination of eftilagimod alpha (efti) with MSD’s anti-PD-1 therapy KEYTRUDA®.

Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC

NCT04811027Active, Not RecruitingPhase 2
Immutep S.A.S.
Posted 8/27/2021

FDA Approves ImmunityBio's Anktiva for Bladder Cancer, Marking Major Milestone for Soon-Shiong's Immunotherapy Approach

Drug ApprovalOncology
  • The FDA has approved ImmunityBio's lead drug Anktiva for treating a common form of bladder cancer, representing a significant breakthrough after years of development and regulatory challenges.
  • Anktiva harnesses the body's natural killer cells and T-cells to fight cancer, with clinical trials showing the ability to eliminate bladder cancer cells for at least four years.
  • ImmunityBio plans to begin distributing Anktiva to healthcare providers by mid-May 2024, with the company having built a three-year stockpile of the drug during the FDA review process.

Tirzepatide Shows Promise as First Pharmaceutical Treatment for Obstructive Sleep Apnea in Obesity

  • Phase 3 clinical trial results published in The New England Journal of Medicine demonstrate tirzepatide reduces obstructive sleep apnea severity by up to 62.8% in adults with obesity.
  • The SURMOUNT-OSA trial showed that 43-51.5% of participants receiving the highest dose of tirzepatide met criteria for "disease resolution" of obstructive sleep apnea.
  • Researchers believe tirzepatide could become the first pharmaceutical treatment for obstructive sleep apnea, potentially offering an alternative to continuous positive airway pressure (CPAP) therapy.

Tislelizumab Approved in Europe for Non-Small Cell Lung Cancer Treatment

The European Commission has approved tislelizumab for treating non-small cell lung cancer (NSCLC) in both frontline and second-line settings. This approval is based on positive outcomes from three phase 3 trials, offering new hope for patients with advanced stages of the disease.

A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous Non-small Cell Lung Cancer

NCT03663205CompletedPhase 3
BeiGene
Posted 7/23/2018

A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer

NCT03594747CompletedPhase 3
BeiGene
Posted 7/30/2018

Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)

NCT03358875CompletedPhase 3
BeiGene
Posted 11/30/2017

FDA Approves Alvotech/Teva's Ustekinumab Biosimilar, SELARSDI

  • The FDA has approved SELARSDI (ustekinumab-aekn), a biosimilar to Johnson & Johnson’s STELARA® (ustekinumab), for treating moderate to severe plaque psoriasis and active psoriatic arthritis.
  • SELARSDI, developed by Alvotech and to be commercialized by Teva in the U.S., is administered as a subcutaneous injection for adult and pediatric patients aged six years and older.
  • This marks the second ustekinumab biosimilar approved by the FDA, following Amgen’s WEZLANA, and Alvotech and Teva settled with Johnson & Johnson to market it no later than February 21, 2025.

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