QUILT-3.028: Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors

NCT03027128 | Completed Phase 1 Results FDA Drug

• 1 other identifier: QUILT-3.028
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor

Keywords

Phase 1; Metastatic; Locally Advanced; Cancer; Cell Therapy

Outcome Measures

Primary Outcomes (3)

• Determination of Maximum Tolerated Dose (MTD) or Highest Tested Dose (HTD).

  28 days/4 weeks

• Occurrence of Dose-limiting Toxicities (DLTs).

  28 days/4 weeks

• Number of Participants With Treatment-emergent Adverse Event (AEs) and Serious Adverse Events (SAEs)

  The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.

Study Arms (1)

Cohort 1, 2x10^9 Cells haNK™

EXPERIMENTAL

NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous Infusion

Biological: haNK™ for Infusion

Interventions

haNK™ for Infusion BIOLOGICAL

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).

Also known as: NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous

Cohort 1, 2x10^9 Cells haNK™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen following the conclusion of the most recent anticancer treatment. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
• Must be willing to provide pre- and post-infusion blood samples.
• 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 for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential are considered all female subjects being physiologically capable of becoming pregnant. Female subjects of child-bearing potential are usually premenopausal women or women with less than 12 months of amenorrhea post-menopause and who have not undergone surgical sterilization. Female subjects of child-bearing potential and non-sterile male subjects must agree to use effective contraception for at least 60 days (female) and 120 days (male) after the last dose of haNK. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.

You may not qualify if:

• History of persistent grade 2 or higher (CTCAE Version 4.03) hematological toxicity resulting from previous therapy.
• 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:
• White blood cell (WBC) count \< 2,500 cells/mm\^3
• Absolute neutrophil count \< 1,500 cells/mm\^3.
• Platelet count \< 100,000 cells/mm3.
• Hemoglobin \< 9 g/dL.
• Total bilirubin greater than the upper limit of normal (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.
• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Interventions

Suspensions

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

There is an insufficient number of subjects enrolled in order to evaluate efficacy.

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 20, 2017
• Study Start: August 2, 2017
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)