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

NCT ID: NCT06614686

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2027-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

U87 autologous CAR T-cell injection

Two stages: dose escalation and dose expansion

Group Type: EXPERIMENTAL

U87 autologous CAR T-cell

Intervention Type: DRUG

Treatment with U87 chimeric antigen receptor T-cell infusion.

Interventions

U87 autologous CAR T-cell

Treatment with U87 chimeric antigen receptor T-cell infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects have provided informed consent, understanding the study's risks and benefits, and are willing to complete the study procedures.

2. Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.

3. ECOG performance status of 0-1.

4. Anticipated survival of at least 12 weeks.

5. Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available

6. Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.

7. At least one measurable tumor lesion according to RECIST 1.1.

8. Suitable venous access for mononuclear cell collection.

9. Adequate major organ function.

10. 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.

Exclusion Criteria

1. Inadequate washout period from prior anti-cancer treatments before leukapheresis.

2. Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.

3. Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.

4. Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.

5. Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.

6. Active infection requiring intravenous anti-infective therapy.

7. Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.

8. Primary immunodeficiency or active autoimmune disease.

9. Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.

10. Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.

11. History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.

12. Allergy to protein drugs or multiple medications.

13. 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.

14. Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.

Pregnant or breastfeeding women.

15. Uncontrollable psychiatric history.

16. Other conditions deemed unsuitable for study participation by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eye ENT Hospital of Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Haitao Wu, Ph.D

Role: CONTACT

eentwuhaitao@163.com

13585504678

Jian Chen, Ph.D

Role: CONTACT

wzcj21@163.com

18917785406

Facility Contacts

Jian Chen, Ph.D

Role: primary

chenjent@qq.com

18917785406

Other Identifiers

U87-01

Identifier Type: -

Identifier Source: org_study_id