QUILT-3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers

NCT04050709 | Completed Phase 1 FDA Drug

• 1 other identifier: QUILT-3.064
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 study to assess the safety, preliminary efficacy of PD-L1 t-haNK and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers.

Conditions

Metastatic Cancer; Locally Advanced Solid Tumor; Solid Tumor

Outcome Measures

Primary Outcomes (2)

• MTD or HTD and RP2D.

  Maximum tolerated dose or highest tested dose and recommended phase 2 dose.

  1 year

• Incidence of DLTs and treatment-emergent adverse events

  Incidence of DLTs and treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  1 year

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  1 year

• Progression-free Survival (PFS)

  1 year

• Overall Survival (OS)

  1 year

Study Arms (4)

PD-L1 t-haNK Dose Level 1

EXPERIMENTAL

PD-L1 t-haNK will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into Dose Level 1 is 3 to 6.

Biological: PD-L1 t-haNK

PD-L1 t-hanK Dose Level 2

EXPERIMENTAL

PD-L1 will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into Dose Level 2 is 3 to 6.

Biological: PD-L1 t-haNK

PD-L1 t-haNK Dose Level Recommended phase 2 dose (RP2D)

EXPERIMENTAL

PD-L1 will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into RP2D is 4.

Biological: PD-L1 t-haNK

PD-L1 t-haNk Dose -1a (if needed)

EXPERIMENTAL

PD-L1 will be administered to patients with locally advanced or metastatic solid cancers. Planned number of subjects to be enrolled into Dose Level -1a is 3 to six, if needed.

Biological: PD-L1 t-haNK

Interventions

PD-L1 t-haNK BIOLOGICAL

PD-L1 t-haNK Suspension for Infusion

PD-L1 t-haNK Dose Level 1; PD-L1 t-haNK Dose Level Recommended phase 2 dose (RP2D); PD-L1 t-haNk Dose -1a (if needed); PD-L1 t-hanK Dose Level 2

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 Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
• Have histologically confirmed unresectable, locally advanced or metastatic solid cancer regardless of tumor PD-L1 expression levels.
• 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 and prior treatment with a checkpoint inhibitor as per FDA indication for current standard-of-care therapy is allowed.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have at least 1 measurable lesion and/or non-measurable disease evaluable in accordance with RECIST Version 1.1.
• Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen obtained following the conclusion of the most recent anticancer treatment and be willing to release the specimen for exploratory tumor molecular profiling. 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 for exploratory analyses.
• 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 must agree to use effective contraception while on study and for at least 5 months after the last dose of PD-L1 t-haNK for Infusion. Non-sterile male subjects must agree to use a condom while on study and for up to 5 months after the last dose of PD-L1 t-haNK for Infusion. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.

You may not qualify if:

• Body weight ≤ 50 kg at screening.
• 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:
• Absolute neutrophil count (ANC) \< 750 cells/mm3.
• Platelet count \< 75,000 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 (ALP) 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 \> 160 mm Hg and/or diastolic \> 110 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.

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

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 8, 2019
• Study Start: July 18, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 25, 2026
• Last Updated: April 1, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)