MedPath

Kiromic BioPharma Expands Deltacel-01 Trial for NSCLC to University of Arizona Cancer Center

• Kiromic BioPharma has activated the University of Arizona Cancer Center as the fifth clinical trial site for its Deltacel-01 Phase 1 trial. • The trial evaluates Deltacel™ (KB-GDT-01), an allogeneic gamma delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC). • The primary objective is to assess safety, with secondary endpoints including objective response and overall survival in patients who have failed standard therapies. • Patient enrollment at the University of Arizona Cancer Center is expected to commence in the coming weeks, expanding the trial's reach.

Kiromic BioPharma, Inc. has announced the activation of the University of Arizona Cancer Center (UACC) as the fifth clinical trial site for the ongoing Deltacel-01 Phase 1 trial. This trial is evaluating Deltacel™ (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to standard treatments. The UACC is one of the 57 NCI-Designated Comprehensive Cancer Centers in the U.S.
Dr. Ricklie Ann Julian, Assistant Professor of Medicine at UACC, will serve as the Principal Investigator at the site. Patient enrollment is expected to begin in the coming weeks.

Deltacel-01 Trial Details

The Deltacel-01 trial (NCT06069570) is an open-label Phase 1 study designed to evaluate the safety and tolerability of Gamma Delta T cell infusions in combination with low-dose radiotherapy in subjects with stage 4 metastatic NSCLC. Patients will receive two intravenous infusions of Deltacel™ along with four courses of low-dose, localized radiation over a 10-day period.
The primary objective of the trial is to assess the safety of Deltacel™. Secondary endpoints include objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

About Deltacel™

Deltacel™ (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in Phase 1 clinical trials for stage 4 metastatic NSCLC. This allogeneic product consists of unmodified, donor-derived gamma delta T cells and is designed to target solid cancers. NSCLC accounts for approximately 80% to 85% of all lung cancer cases. Preclinical data has indicated a favorable safety and efficacy profile when Deltacel™ is combined with low-dose radiation.

Kiromic BioPharma's Approach

Kiromic BioPharma, Inc. is a clinical-stage biotherapeutics company utilizing its DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focused on immuno-oncology. The company is developing an allogeneic cell therapy platform that leverages the natural capabilities of Gamma Delta T-cells to target solid tumors.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

CytoMed and SunAct Partner to Advance Gamma Delta T-Cell Therapy for Solid Tumors in India

CytoMed Therapeutics and SunAct Cancer Institute collaborate to evaluate allogeneic gamma delta T cells for solid tumor treatment in a Phase 2 trial.
The trial will assess the safety, tolerability, potency, and efficacy of CytoMed's cell therapy across various solid cancer types.

Immunocore Advances Novel Immunotherapies Targeting PRAME and PIWIL1 in Phase 1 Trials

Immunocore has dosed the first patient in a Phase 1 trial of IMC-P115C, a half-life extended ImmTAC candidate targeting PRAME, designed to improve patient convenience through less frequent administration.
The Phase 1 trial will assess the safety, pharmacokinetics, and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with advanced cancers expressing PRAME.

UHKT Launches Phase I Trial of Linea DNA-Enabled CAR T-Cell Therapy for AML

The State Institute for Drug Control of the Czech Republic has approved a Phase I clinical trial for UHKT-CAR123-01, a CD123-specific autologous CAR T-cell therapy.
UHKT-CAR123-01 utilizes Applied DNA's Linea DNA in its manufacturing process, aiming to reduce costs and timelines associated with CAR T-cell production.

uniQure Receives FDA Nod for Accelerated Approval Pathway for Huntington's Disease Gene Therapy

uniQure secured FDA agreement to pursue accelerated approval for its Huntington's disease gene therapy, potentially expediting treatment availability.
The FDA's decision reflects a more flexible approach to genetic medicines for severe rare diseases under Peter Marks.

Adicet Bio Initiates Phase 1 Trial of ADI-270, a Novel CAR T-cell Therapy for Advanced Kidney Cancer

Adicet Bio has commenced a Phase 1 clinical trial for ADI-270, an allogeneic gamma delta CAR T-cell therapy, in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC).
ADI-270 targets CD70-positive cancers and is engineered to overcome the immunosuppressive tumor microenvironment, potentially offering a new treatment option for solid tumors.

Phase 1 Trial Shows Promise for Recurrent Glioblastoma with Targeted Radiopharmaceutical

A Phase 1 clinical trial (CITADEL-123) at UCLH is evaluating ATT001, an Iodine-123 labelled PARP inhibitor, for recurrent glioblastoma, delivering targeted radioactivity to cancer cells.
The first patient in the trial experienced a 50% reduction in tumor size following treatment with ATT001, showcasing the potential of Auger therapy.

Akiram Therapeutics' AKIR001 Receives Clearance for Phase 1 Trial in Advanced Solid Tumors

Akiram Therapeutics' 177Lu-AKIR001, a novel targeted radioimmunotherapy, has been approved to enter Phase 1 clinical trials.
The Phase 1 trial will primarily assess the safety and tolerability of 177Lu-AKIR001 in patients with advanced solid tumors expressing CD44v6.

CytoMed Therapeutics' ANGELICA Trial Receives Approval for Phase I Study in Advanced Cancers

CytoMed Therapeutics has received full approval for its Phase I ANGELICA trial, evaluating allogeneic CAR-T cell therapy in advanced cancers.
The ANGELICA trial uses gamma delta T cells from healthy donors, potentially improving CAR-T cell quality and reducing production costs.

Kiromic BioPharma's Deltacel Shows Promise in NSCLC Trial, Moves to Dose Expansion

Kiromic BioPharma's Deltacel (KB-GDT-01) receives unanimous approval from the Safety Monitoring Committee to advance into the dose expansion phase of its Phase 1/2 trial for NSCLC.
Interim data from the Deltacel-01 trial shows a median progression-free survival of 6 months and tumor reduction in some patients with advanced NSCLC.

CytoMed Soars On Research Deal With SunAct Cancer Institute for Solid Tumor Treatment Trial in India

CytoMed Therapeutics Limited has entered into a Business & Research Collaboration Agreement with SunAct Cancer Institute Private Limited to explore the safety, efficacy, and tolerability of CytoMed's allogeneic gamma delta T cells in treating solid cancers, including a Phase 2 trial in India.

Reference News

[1]
Kiromic BioPharma Activates the University of Arizona Cancer Center as the Fifth Clinical ...
biospace.com · Sep 19, 2024

Kiromic BioPharma activates UACC as the fifth site for its Deltacel-01 Phase 1 trial, evaluating Deltacel™, an allogenei...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy