U87 CAR-T in Patients With Advanced Head and Neck Tumors

NCT06614686 | Recruiting Phase 1 DMC

• 1 other identifier: U87-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.

Conditions

Nasopharynx Cancer; Head and Neck Cancer

Keywords

Chimeric Antigen Receptor T Cell; U87

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]

  An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  28 days post administration of CAR-T-cells

Secondary Outcomes (9)

• Pharmacokinetics of U87 CAR-T cells

  2 years post CAR T cell infusion

• Pharmacokinetics of U87 CAR-T cells

  2 years post CAR T cell infusion

• Pharmacokinetics of U87 CAR-T cells

  2 years post CAR T cell infusion

• Pharmacodynamics of U87 CAR-T cells

  2 years post CAR T cell infusion

• Objective Response Rate (ORR), as assessed by Investigators

  2 years post CAR T cell infusion

Study Arms (1)

U87 autologous CAR T-cell injection

EXPERIMENTAL

Two stages: dose escalation and dose expansion

Drug: U87 autologous CAR T-cell

Interventions

U87 autologous CAR T-cell DRUG

Treatment with U87 chimeric antigen receptor T-cell infusion.

U87 autologous CAR T-cell injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects have provided informed consent, understanding the study\'s risks and benefits, and are willing to complete the study procedures.
• Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.
• ECOG performance status of 0-1.
• Anticipated survival of at least 12 weeks.
• Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available
• Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.
• At least one measurable tumor lesion according to RECIST 1.1.
• Suitable venous access for mononuclear cell collection.
• Adequate major organ function.
• Negative pregnancy test for women of reproductive age at screening; sexually active subjects must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.

You may not qualify if:

• Inadequate washout period from prior anti-cancer treatments before leukapheresis.
• Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.
• Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.
• Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.
• Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.
• Active infection requiring intravenous anti-infective therapy.
• Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.
• Primary immunodeficiency or active autoimmune disease.
• Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.
• Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.
• History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.
• Allergy to protein drugs or multiple medications.
• Other untreated malignancies within 5 years prior to study drug use. History of immune deficiency, hematopoietic stem cell/organ transplantation. Uncontrollable third-space fluid accumulation.
• Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: lead

Study Sites (1)

Eye ENT Hospital of Fudan University

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Haitao Wu, Ph.D

CONTACT

13585504678; eentwuhaitao@163.com

Jian Chen, Ph.D

CONTACT

18917785406; wzcj21@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)