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CAR T-cell Therapy

M-CENK for Advanced or Metastatic Cancer

Phase 1

Recruiting

Research Sponsored by ImmunityBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 histologically confirmed locally advanced, unresectable, or metastatic solid tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from m-cenk dose number 1 through end of study (up to 12 months from first dose), assessed for up to 12 months

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of two drugs for treating advanced or metastatic solid tumors. It includes two cohorts of patients: one with newly diagnosed tumors and one with tumors that have progressed after prior treatment.

Who is the study for?

Adults with advanced solid tumors that can't be surgically removed or have spread, who've had prior treatments (or none for newly diagnosed), and are able to follow the study plan. They must have measurable disease, adequate organ function, no serious illnesses or autoimmune diseases, not on certain medications like high-dose steroids, and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing a new therapy called M-CENK with N803 in two groups: one with patients new to treatment or after first-line therapy; another with those whose cancer returned after at least two treatments. It's an early-phase study checking safety and initial results of these drugs.See study design

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions related to immune therapies such as flu-like symptoms, fatigue, allergic reactions, and possibly effects on blood counts or organ functions due to the nature of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has a genetic mutation and has worsened despite targeted therapy.

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My cancer is advanced, cannot be surgically removed, or has spread.

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I am on HCV treatment and my HCV levels are undetectable.

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I am 18 years old or older.

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I had hepatitis C but have completed treatment and now have an undetectable viral load.

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I can take care of myself and am up and about more than half of my waking hours.

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I can sit still for 5-6 hours, have good vein access, and meet the blood and health criteria for an Apheresis procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from m-cenk dose number 1 through end of study (up to 12 months from first dose), assessed for up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from m-cenk dose number 1 through end of study (up to 12 months from first dose), assessed for up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from m-cenk dose number 1 through end of study (up to 12 months from first dose), assessed for up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Objective (cohort 1 and cohort 2, part A subjects): Determine the safety of mononuclear cell (MNC) apheresis collection by number of participants with abnormal vital signs.

Primary Objective (cohort 1 and cohort 2, part A subjects): Determine the safety of mononuclear cell (MNC) apheresis collection by the number of participants with clinically significant laboratory tests.

Primary Objective (cohort 1 and cohort 2, part A subjects): Determine the safety of mononuclear cell (MNC) apheresis collection by the number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to apheresis.

+3 more

Secondary outcome measures

Cohort 1 and cohort 2, part A subjects: Evaluate the quantity and quality of the manufactured cells from subjects in cohort 1 vs. cohort 2 by the number of MNCs collected and the % of natural killer (NK) cells.

Cohort 1 and cohort 2, part A subjects: Evaluate the quantity and quality of the manufactured cells from subjects in cohort 1 vs. cohort 2 by the number, phenotype (CD56/CD16 positive and CD3 positive cells), and function of M-CENK cells.

Cohort 2, part B subjects: Evaluate overall safety profile of up to 10 doses of M-CENK and up to 5 doses of N-803 in subjects with relapsed or refractory (R/R) solid tumors by the number of participants with clinically significant laboratory tests.

+7 more

Other outcome measures

Cohort 1/2, part A subjects: Evaluate and compare immune profiles of whole blood and apheresis product by function of NK cells and NK cell receptor profile by intracellular staining for cytokines, surface marker staining, and assessments of cytotoxicity.

Exploratory Objective (cohort 1 and cohort 2, part A subjects): Evaluate and compare immune profiles of whole blood and apheresis product by frequency and phenotype of immune cells as measured by flow and mass cytometry..

Exploratory Objective (cohort 1 and cohort 2, part A subjects): Evaluate and compare immune profiles of whole blood and apheresis product by frequency, number, phenotype, and proliferation of NK cells as measured by flow and mass cytometry.

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Subjects with relapsed/refractory (r/r) solid tumorsExperimental Treatment2 Interventions

Cohort 2: Subjects with relapsed/refractory (r/r) solid tumors who have progressive disease after receiving ≥ 2 prior therapies or not a candidate for therapy of proven efficacy for their disease.

Group II: Cohort 1: Subjects newly diagnosed no prior therapy or prior first line treatmentExperimental Treatment1 Intervention

Cohort 1: Subjects with either newly diagnosed solid tumors who have not received prior therapy or subjects who have received prior first line treatment. Cohort 1 may subsequently enroll in cohort 2 part B if they have progressive disease after ≥ 2 prior therapies or if they have progressive disease within 12 months of receiving neoadjuvant or adjuvant chemotherapy and meet the inclusion criteria for cohort 2 part B.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor

63 Previous Clinical Trials

5,086 Total Patients Enrolled

Leonard Sender, MDStudy DirectorImmunityBio, Inc.

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

M-CENK (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04898543 — Phase 1

$Metastatic Tumor Research Study Groups: Cohort 2: Subjects with relapsed/refractory (r/r) solid tumors, Cohort 1: Subjects newly diagnosed no prior therapy or prior first line treatment$