N-803 Maintenance Therapy Post CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas

NCT07049432 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: HCI189957
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to learn whether the study drug N-803 is safe and tolerable in patients with B-cell non-Hodgkin lymphoma who have undergone CAR T-cell therapy.

Conditions

B-cell Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• The maximum tolerated dose (MTD) of N-803 post CAR T-cell therapy

  determination of a dose level for the phase 2 study (RP2D)

  4 years

• Determination of a dose level for the phase 2 study (RP2D) of N-803 post CAR T-cell Therapy

  determination of a dose level for the phase 2 study (RP2D)

  4 years

Secondary Outcomes (4)

• The proportion of patients with a Partial Response (PR), per Lugano criteria, who achieve a Complete Response (CR) by the end of Cycle 6.

  2 years

• Duration of response (DoR), defined as the interval of time from the date of initial documented response (PR or CR per Lugano criteria) to the time of progression, the start of a new therapy, or death from any cause.

  2 years

• Progression-free survival (PFS) as defined as the time from study drug initiation to the time documented disease progression (as assessed by Lugano Criteria) or death from any cause.

  2 years

• Overall survival (OS) as defined as the time from initiation of study therapy until death from any cause.

  2 years

Study Arms (1)

N-803

EXPERIMENTAL

Participants receive N-803 subcutaneously (SubQ) administered on day 1 of each 21-day cycle for up to 6 cycles.

Drug: N803

Interventions

N803 DRUG

N-803 subcutaneously (SubQ) administered on day 1 of each 21-day cycle for up to 6 cycles.

N-803

Eligibility Criteria

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

You may qualify if:

• Subjects aged ≥ 18 years.
• Subjects with histologically confirmed B-cell NHL who have received commercially approved CD19-directed CAR T-cell therapy per FDA label
• Subjects achieving CR or PR per Lugano Criteria to CAR T-cell therapy on D+30 post-CAR-T.
• ECOG Performance Status ≤ 2.
• Adequate organ function as defined as:
• Hematologic:
• Absolute neutrophil count (ANC) ≥750 cells/mm3 (≥0.75 x 10\^9/L) independent of G-CSF support
• Platelet count ≥50,000 cells/mm\^3 (≥50 x 10\^9/L) independent of transfusion support
• Hemoglobin ≥ 7 g/dL (≥ 70 g/L) independent of transfusion support
• Hepatic:
• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) or ≤ 3x ULN with Gilbert's disease.
• AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
• Renal:
• Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:
• Males: ((140-age)×weight\[kg\])/(serum creatinine \[mg/dL\]×72)

You may not qualify if:

• Prior therapy with N-803, IL-2 or IL-15 based therapy.
• Receiving other investigational agents.
• Any ongoing toxicity from CAR T-cell therapy that, in the judgment of the investigator, may interfere with study treatment.
• Autoimmune disease requiring active treatment, other than corrected hypothyroidism and diabetes mellitus type 1.
• History of a prior or current malignancy that, in the opinion of the investigator, is likely to negatively impact subject participation or safety.
• Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
• \-- Cardiovascular disorders:
• Stroke or intracranial hemorrhage within 6 months of enrollment
• Unstable angina or acute coronary syndrome within the past 2 months prior to study enrollment
• History of myocardial infarction within 3 months prior to study enrollment in the 12 months prior to study enrollment
• ≥ Grade 3 NYHA functional classification system of heart failure, uncontrolled or symptomatic arrhythmias
• Left ventricular ejection fraction \< 40% in the 12 months prior to study enrollment.
• \---- Note: A screening echo is not required for enrollment.
• Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[subjects may not receive the drug through a feeding tube\], social/ psychological issues, etc.)
• Known HIV infection.

Sponsors & Collaborators

• University of Utah: lead
• ImmunityBio, Inc.: collaborator

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

ALT-803

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Narendranath Epperla, MD, MS, FACP

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)