HV-101 for Patients With Advanced Solid Tumors

NCT ID: NCT05868915

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2026-01-15

Brief Summary

Background:

Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to treat patients. TIL therapy has shown strong efficacy for the treatment of solid tumors, and has achieved high objective response rates in multiple cancers.

Objective:

To evaluate the safety and efficacy of HV-101 for the treatment of advanced solid tumors.

Eligibility:

Adults aging 18-75 with advanced solid tumors

Design:

1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.

2. Freshly resected patient tumors were dissected by the surgeon.

3. TIL cells were isolated from the patient's tumor tissue in the laboratory, then cultured in vitro, activated and expanded.

4. HV-101 will be re-infused into the patient.

Conditions

Advanced Solid Tumors

Study Design

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

Study Groups

HV-101

Participants with Advanced Solid Tumors

Interventions:

Biological: HV-101

Drug: IL-2

Drug: Fludarabine Drug: Cyclophosphamide

Group Type: EXPERIMENTAL

HV-101

Intervention Type: BIOLOGICAL

Biological: HV-101

HV-101 is autologous tumor-infiltrating lymphocyte cells without genetic modification.

Drug: IL-2

Following cell infusion, the patient receives intravenous IL-2.

Drug: Fludarabine

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Drug: Cyclophosphamide

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Interventions

HV-101

Biological: HV-101

HV-101 is autologous tumor-infiltrating lymphocyte cells without genetic modification.

Drug: IL-2

Following cell infusion, the patient receives intravenous IL-2.

Drug: Fludarabine

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Drug: Cyclophosphamide

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial.

2. Age ≥ 18 years and ≤ 75 years.

3. Expected survival time > 3 months.

4. ECOG score 0-1.

5. At least one lesion that could undergo surgery or biopsy to obtain tumor tissue for TIL preparation

6. At least 1 measurable lesion (according to RECIST v1.1).

7. Metastatic or recurrent solid tumors confirmed by histopathology. Refractory to standard treatment evaluated by radiological assessment.

8. Hematology should at least meet the following criteria:

• Absolute neutrophil count (ANC) ≥ 1.5× 109/L；
• Platelet (PLT） ≥ 75× 109/L；
• Hemoglobin (HGB) ≥ 90 g/L.

9. Liver and kidney function are normal:

• Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml/min;
• Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤ 2.5 times of ULN;
• Total bilirubin (TBIL) ≤ 1.5 times of ULN.

10. Blood coagulation function is normal:

• Prothrombin time (PT) ≤ 1.5 ULN;
• International Normalized Ratio (INR) ≤ 1.5 ULN;
• or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN.

11. Women of childbearing potential should be ascetic or take contraception since the signing of ICF to 24 weeks or later after the last administration of drug.

Exclusion Criteria

1. Under pregnancy or lactation, or positive based on blood pregnancy test.

2. Severe allergic to related ingredients in the clinical trial.

3. Received any other investigational treatment within 28 days before the administration of HV-101.

4. History of other known malignant tumors within the previous 5 years.

5. Primary central nerve system (CNS) cancer, or Participants with CNS metastasis after localized treatment.

6. Participants with any active autoimmune disease, a history of autoimmune disease, or a history or syndrome requiring treatment with systemic steroids or immunosuppressive drugs.

7. Immunodeficiency including HIV positive, acquired or primary immunodeficiency.

8. Participants with ≥ grade 3 thromboembolic events within 6 months or under thrombolysis treatment.

9. Participants with hereditary or acquired hemorrhagic disease.

10. Participants with clinical cardiovascular disease or symptoms

11. Participants with active infection.

12. Participants with active pulmonary tuberculosis infection.

13. Participants with positive hepatitis B surface antigen or positive hepatitis B core antibody or positive hepatitis C virus antibody.

14. Treponema pallidum antibody positive.

15. Participants received major surgery or under severe injury within 28 days before HV-101 infusion.

16. Participants who received live vaccine or attenuated live vaccine 28 days before HV-101 infusion.

17. Participants who have drug addiction history, alcoholism, or drug users.

18. Participants who received cell therapy before enrollment.

19. Participants who have contraindications to the treatment of IL-2 injection.

20. Participants not suitable for the clinical trial evaluated by the investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: collaborator

Hervor Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

CV101

Identifier Type: -

Identifier Source: org_study_id