Trials Sponsors Conditions Drugs Pricing

Conditions

Head and Neck Cancer Nasopharynx Cancer

Keywords

Chimeric Antigen Receptor T CellU87

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
+4 more secondary outcomes

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-cellDrug

Treatment with U87 chimeric antigen receptor T-cell infusion.

U87 autologous CAR T-cell injection

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects have provided informed consent, understanding the study\&#39;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.

Sponsors & Collaborators

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Industrylead

Study Sites (1)

Eye ENT Hospital of Fudan University

Shanghai, 200000, China

RECRUITING

Jian Chen, Ph.DCONTACT18917785406 chenjent@qq.com

Hongmeng Yu, Ph.DPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Haitao Wu, Ph.D

CONTACT

13585504678 eentwuhaitao@163.com

Jian Chen, Ph.D

CONTACT

18917785406

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

October 31, 2026

Estimated

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

U87 autologous CAR T-cell injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

U87 autologous CAR T-cell injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations