Clinical trial NCT05868915: HV-101 for Patients With Advanced Solid Tumors
Official title: A Phase I/II Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of HV-101 Injection for the Patients With Recurrent or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Hervor Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Renmin Hospital of Wuhan University
First posted: 2023-05-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety of HV-101
timeFrame: Day 0 - Day 730
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Day 0 - Day 730
measure: Duration of Response (DOR)
timeFrame: Day 0 - Day 730
measure: Disease Control Rate (DCR)
timeFrame: Day 0 - Day 730
measure: Progression free survival (PFS)
timeFrame: Day 0 - Day 730
measure: Overall survival (OS)
timeFrame: Day 0 - Day 730
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References: