Nasopharynx CancerPhase 1NCT06614686
U87 CAR-T in Patients With Advanced Head and Neck Tumors
A Phase 1 study testing U87 autologous CAR T-cell in people with Nasopharynx Cancer and Head and Neck Cancer, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharynx Cancer, Head and Neck Cancer
- What is being tested?
- U87 autologous CAR T-cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Uncontrollable psychiatric history.
- Other conditions deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye ENT Hospital of Fudan University
Shanghai, 200000
Jian Chen, Ph.D, 18917785406, chenjent@qq.com
Hongmeng Yu, Ph.D
About this study
Official title: A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors
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.
Read the detailed description
Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
- Conditions
- Nasopharynx Cancer, Head and Neck Cancer
- Being tested
- U87 autologous CAR T-cell
- Keywords
- Chimeric Antigen Receptor T Cell, U87
- Medical subject headings
- Nasopharyngeal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U87 autologous CAR T-cellDrug
Treatment with U87 chimeric antigen receptor T-cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| U87 autologous CAR T-cell injection | Experimental | Two stages: dose escalation and dose expansion Receives: Drug: U87 autologous CAR T-cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days post administration of CAR-T-cells
Secondary outcomes (9)
Pharmacokinetics of U87 CAR-T cells
Time at the maximal concentration(Tmax)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Area under the concentration-time curve(AUC)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
The maximal concentration of eripheral blood (Cmax)
Measured: 2 years post CAR T cell infusion
Pharmacodynamics of U87 CAR-T cells
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point
Measured: 2 years post CAR T cell infusion
Objective Response Rate (ORR), as assessed by Investigators
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Measured: 2 years post CAR T cell infusion
Duration of response (DOR), as assessed by Investigators
Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Measured: 2 years post CAR T cell infusion
Overall survival (OS)
Overall Survival (OS) was defined as the time from the date of first infusion of U87 to the date of death due to any cause.
Measured: 2 years post CAR T cell infusion
Progression-free survival (PFS), as assessed by Investigators
Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Measured: 2 years post CAR T cell infusion
Disease control rate (DCR), as assessed by Investigators
Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Measured: 2 years post CAR T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start20 Sep 2024 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharynx CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614686
- Sponsor's protocol ID
- U87-01
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT06614686
- Acronym / sponsor ID
- U87-01
- Conditions
- Nasopharynx Cancer, Head and Neck Cancer
- Keywords
- Chimeric Antigen Receptor T Cell, U87
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U87 autologous CAR T-cell injection | Experimental | Drug: U87 autologous CAR T-cellTwo stages: dose escalation and dose expansion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| U87 autologous CAR T-cellTreatment with U87 chimeric antigen receptor T-cell infusion. | Drug | U87 autologous CAR T-cell injection |
Primary outcome
Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]
Time frame: 28 days post administration of CAR-T-cells
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
9 secondary outcomes
Pharmacokinetics of U87 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacodynamics of U87 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Objective Response Rate (ORR), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
Duration of response (DOR), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
Overall survival (OS)
Time frame: 2 years post CAR T cell infusion
Progression-free survival (PFS), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
Disease control rate (DCR), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing U87 autologous CAR T-cell in people with Nasopharynx Cancer and Head and Neck Cancer, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haitao Wu, Ph.D (13585504678, eentwuhaitao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability] (time frame: 28 days post administration of CAR-T-cells). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.