Safety, Tolerability, PK, and Efficacy of CD-001 in Advanced Head & Neck Cancers

Official title

A Clinical Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Head & Neck Cancers

Overview

The goal of this prospective, single-center, open-label, dose-escalation study is to evaluate the safety, tolerability, and preliminary efficacy of CD-001 in patients with advanced head and neck cancers who have experienced disease progression (PD) or intolerance to standard systemic therapy (or lack thereof). The main question\[s\] it aims to answer: * What is the safety and tolerability profile of CD-001 across escalating doses? * What is the preliminary efficacy of CD-001 in this patient population?

Interventions

• Drug CD-001
  CD-001 administered as an intravenous (lV)infusion.

Primary outcome measures

• Adverse events [Time frame: up to 12 months]

Secondary outcome measures (3)

• Objective response rate [Time frame: up to 12 months]
• Progress-Free Survival [Time frame: up to 12 months]
• Overall Survival [Time frame: up to 12 months]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years , regardless of gender.
• Patients with advanced head and neck cancer that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.
• ECOG score ≤ 2.
• At least one measurable lesion as defined by RECIST v1.1.
• Expected survival ≥ 3 months.

Exclusion criteria

• Patients with known active central nervous system (CNS) and/or leptomeningeal metastases .
• Patients who have undergone major organ surgery within 4 weeks prior to the first dosing, or who are expected to require major surgery during this study, or who have severe unhealed wounds, trauma, ulcers, etc.
• Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant.
• Patients who have a past or current history of active or chronic autoimmune disease and who have required systemic therapy within the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease.
• Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing.
• At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.
• Patients with a history of ≥ Grade 3 (CTCAE) immune-related adverse events (irAEs) during prior anti-tumor therapy or permanent drug discontinuation due to irAEs.
• Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Cieri N, Camisa B, Cocchiarella F, Forcato M, Oliveira G, Provasi E, Bondanza A, Bordignon C, Peccatori J, Ciceri F, Lupo-Stanghellini MT, Mavilio F, Mondino A, Bicciato S, Recchia A, Bonini C. IL-7 and IL-15 instruct the generation of human memory stem T cells from naive precursors. Blood. 2013 Jan 24;121(4):573-84. doi: 10.1182/blood-2012-05-431718. Epub 2012 Nov 15. PMID 23160470
• Sabatino M, Hu J, Sommariva M, Gautam S, Fellowes V, Hocker JD, Dougherty S, Qin H, Klebanoff CA, Fry TJ, Gress RE, Kochenderfer JN, Stroncek DF, Ji Y, Gattinoni L. Generation of clinical-grade CD19-specific CAR-modified CD8+ memory stem cells for the treatment of human B-cell malignancies. Blood. 2016 Jul 28;128(4):519-28. doi: 10.1182/blood-2015-11-683847. Epub 2016 May 25. PMID 27226436
• Alvarez-Fernandez C, Escriba-Garcia L, Vidal S, Sierra J, Briones J. A short CD3/CD28 costimulation combined with IL-21 enhance the generation of human memory stem T cells for adoptive immunotherapy. J Transl Med. 2016 Jul 19;14(1):214. doi: 10.1186/s12967-016-0973-y. PMID 27435312
• Moroz A, Eppolito C, Li Q, Tao J, Clegg CH, Shrikant PA. IL-21 enhances and sustains CD8+ T cell responses to achieve durable tumor immunity: comparative evaluation of IL-2, IL-15, and IL-21. J Immunol. 2004 Jul 15;173(2):900-9. doi: 10.4049/jimmunol.173.2.900. PMID 15240677
• Hinrichs CS, Spolski R, Paulos CM, Gattinoni L, Kerstann KW, Palmer DC, Klebanoff CA, Rosenberg SA, Leonard WJ, Restifo NP. IL-2 and IL-21 confer opposing differentiation programs to CD8+ T cells for adoptive immunotherapy. Blood. 2008 Jun 1;111(11):5326-33. doi: 10.1182/blood-2007-09-113050. Epub 2008 Feb 14. PMID 18276844
• Valbon SF, Condotta SA, Richer MJ. Regulation of effector and memory CD8(+) T cell function by inflammatory cytokines. Cytokine. 2016 Jun;82:16-23. doi: 10.1016/j.cyto.2015.11.013. Epub 2015 Dec 10. PMID 26688544
• Kim TK, Herbst RS, Chen L. Defining and Understanding Adaptive Resistance in Cancer Immunotherapy. Trends Immunol. 2018 Aug;39(8):624-631. doi: 10.1016/j.it.2018.05.001. Epub 2018 May 22. PMID 29802087
• Zappasodi R, Merghoub T, Wolchok JD. Emerging Concepts for Immune Checkpoint Blockade-Based Combination Therapies. Cancer Cell. 2018 Apr 9;33(4):581-598. doi: 10.1016/j.ccell.2018.03.005. PMID 29634946

Identifiers

NCT: NCT07072325 · 2025(666)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗