QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors

Running, not enrolling · Phase 1

Conditions studied: Metastatic Solid Tumor

In brief

This is a two-part, open-label phase 1 study to evaluate safety and preliminary efficacy of M-CENK Suspension for Infusion, Cryopreserved, and N-803 for subcutaneous administration in subjects with locally advanced or metastatic solid tumors. The study consists of two cohorts: cohort 1 includes subjects with either newly diagnosed solid tumors who have not received prior therapy or subjects who have received prior first line treatment; and cohort 2 that includes subjects with relapsed/refractory (r/r) solid tumors who have progressive disease after receiving ≥ 2 prior therapies. The two cohorts will be conducted simultaneously.

Key facts

Study ID

NCT04898543

Run by

ImmunityBio, Inc.

People needed

50

Starts

2021-06-21

Expected to finish

2026-05-31

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohorts 1 and 2, Part A:
• 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 locally advanced, unresectable, or metastatic solid tumor.
• For subjects with genetic mutations or alterations in solid tumors (e.g. NSCLC, pancreatic cancer, melanoma), the subjects must have received prior appropriate disease specific targeted therapy and have progressed.
• Have at least 1 measurable lesion and/or non-measurable disease evaluable in accordance with RECIST Version 1.1.
• For subjects with a history of human immunodeficiency virus (HIV)
• Subjects with CD4+ T-cell (CD4+) counts ≥ 350 cells/uL and without a history of AIDS defining opportunistic infections.
• For subjects with a history of hepatitis B virus (HBV)
• Subjects who are chronic carriers of HBV infection (HBsAg-positive, undetectable or low HBV DNA, and normal ALT) who are not on HBV therapy, or in individuals who have serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HBc-positive), anti-HBV prophylaxis should be assessed prior to enrollment.
• Subjects with chronic HBV infection with active disease who meet the criteria for anti HBV therapy should be on a suppressive antiviral therapy prior to enrollment.
• For subjects with a history of hepatitis C virus (HCV)
• Subjects with a history of HCV infection should have completed curative antiviral treatment and have a HCV viral load below the limit of quantification are eligible.
• Subjects who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible.
• Subjects on concurrent HCV treatment and have HCV below the limit of quantification are eligible.
• Note: Subjects who have a history of HIV/HBV/HCV or are seropositive will require Infectious Disease Marker (IDM) testing prior to apheresis collection.
• Subjects who currently have non-progressive brain metastasis and were previously treated with surgical resection/debulking, radiation, and stereotactic radiosurgery.
• Able to undergo an Apheresis procedure:
• Have adequate venous access
• Able to sit or recline for 5-6 hours with limited movement
• Hemoglobin must be ≥ 9.0 g/dL
• Platelet count must be ≥ 100,000 cells/mm3
• Vital signs must be within normal range
• Negative serum pregnancy test for females of childbearing potential.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Where it is running

• Chan Soon-Shiong Institute for Medicine — El Segundo, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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