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Open-label, Phase 1 Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors (NCT03027128)

The purpose of this study is to determine whether haNK™ for Infusion is safe and effective in the treatment of metastatic or locally advanced solid tumors.
  • Biological: haNK™ for Infusion
    haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
    • NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Inclusion Criteria:
  • Age ≥ 18 years old.
  • Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
  • Histologically confirmed, unresectable, locally advanced or metastatic solid malignancy.
  • ECOG performance status of 0 to 2.
  • Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1.
  • Must have an historic FFPE tumor biopsy specimen ≤ 6 months old and be willing to release the specimen for tumor molecular profiling analysis. If an historic specimen is not available or was taken > 6 months from the date of screening, the subject must be willing to undergo a biopsy during the screening period.
  • Must be willing to provide pre- and post-infusion blood samples for exploratory analyses.
  • Have received treatment with at least 1 prior line of therapy in the metastatic setting or not be a candidate for therapy of proven efficacy for their disease. Prior immune therapy is allowed.
  • Resolution of all toxic side effects of prior chemotherapy, radiotherapy, or surgical procedures to CTCAE grade ≤ 1, with the exception of alopecia.
  • Life expectancy ≥ 12 weeks.
  • Ability to attend required study visits and return for adequate follow up, as required by this protocol.
  • Agreement to practice effective contraception (both male and female subjects, if the risk of conception exists). Because the effects of the haNK cells on the developing human fetus are unknown, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 30 days after the last dose of haNK™ for Infusion. If employing contraception, two of the following precautions must be used: vasectomy of partner, tubal ligation, vaginal diaphragm, intrauterine device, condom and spermicidal (gel/foam/cream/vaginal suppository), or total abstinence. Male subjects must be surgically sterile or must agree to use a condom and acceptable contraceptive method with their partner. Female subjects who are postmenopausal are defined as those with an absence of menses for > 12 consecutive months.
Exclusion Criteria:
  • History of persistent grade 2 or higher (CTCAE Version 4.03) hematological toxicity resulting from previous therapy.
  • Evidence of central nervous system disease
  • History of other active malignancies or brain metastasis except: controlled basal cell carcinoma or squamous cell carcinoma; prior history of in situ cancer (eg, breast, melanoma, squamous cell carcinoma of the skin, cervical) and > 5 years without evidence of disease; prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy) and with undetectable PSA (< 0.2 ng/mL).
  • Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
  • Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
  • History of organ transplant requiring immunosuppression.
  • History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  • Inadequate organ function, evidenced by the following laboratory results:
  • WBC count < 3,500 cells/mm3
  • Absolute neutrophil count < 1,500 cells/mm3
  • Platelet count < 100,000 cells/mm3
  • Hemoglobin < 9 g/dL
  • Total bilirubin greater than the ULN (unless the subject has documented Gilbert's syndrome)
  • Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases)
  • Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or > 10 × ULN in subjects with bone metastases)
  • Serum creatinine > 2.0 mg/dL or 177 μmol/L
  • INR or aPTT or PTT > 1.5 × ULN (unless on therapeutic anti-coagulation)
  • Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
  • Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
  • Positive results of screening test for HIV, HBV, or HCV infection.
  • Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  • Known hypersensitivity to any component of the study medication(s).
  • Participation in an investigational drug study or history of receiving any investigational treatment within 28 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Concurrent participation in any interventional clinical trial.
  • Pregnant and nursing women. A negative serum pregnancy test within 72 hours before administration of haNK™ for Infusion must be documented before any haNK™ for Infusion is administered to a woman of childbearing potential (WOCBP). WOCBP are considered all women being physiologically capable of becoming pregnant. WOCBP are usually premenopausal women or women with less than 12 months of amenorrhea post-menopause and who have not undergone surgical sterilization.
This is a phase 1 trial in subjects with metastatic or locally advanced solid tumors. The study will be conducted in two parts: part 1 will involve dose escalation using a 3 + 3 design, and part 2 will involve the expansion of the MTD or HTD to further evaluate the safety of haNK. In part 1, 3 to 6 subjects will be sequentially enrolled starting at dose cohort 1, and subjects will be assessed for DLTs.

- Cohort 1: 2 x 10^9 cells per infusion.

- Cohort 2: 4 x 10^9 cells per infusion.

- If needed, subjects will be enrolled into a dose de-escalation cohort (cohort -1): 1 x 10^9 cells per infusion.

In part 2, dose expansion will occur when the MTD or HTD has been determined. An additional 4 subjects may be enrolled in part 2, for a total of up to 10 subjects at the MTD or HTD.

1 locations

United States (1)
  • Chan Soon-Shiong Institute for Medicine
    El Segundo, California, United States, 90245
01 August, 2017
12 November, 2017
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