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B-cell Non Hodgkin LymphomaPhase 1CARMEN-803NCT07049432

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

A Phase 1 study testing N803 in people with B-cell Non Hodgkin Lymphoma, run by University of Utah at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Non Hodgkin Lymphoma
What is being tested?
N803
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2026to Dec 2031
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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)
  • Females: (((140-age)×weight[kg])/(serum creatinine [mg/dL]×72))×0.85
  • For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women < 50 years of age:
  • Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
  • Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
  • Underwent surgical sterilization (bilateral oophorectomy, or hysterectomy).
  • Women ≥ 50 years of age:
  • Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
  • Had radiation-induced menopause with last menses >1 year ago; or
  • Had chemotherapy-induced menopause with last menses >1 year ago; or
  • Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
  • Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 6.4.1.
  • CRS and ICANS grade 0 at the time of enrollment and N-803 injection. Subjects must be off steroids and ≥7 days from tocilizumab or other anti-cytokine agent administration.
  • Clinically significant adverse effects from any prior treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the Investigator.
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Who cannot join

  • 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:
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  • -- 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.
  • Active infection including hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
  • -- Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation. Screening for chronic conditions is not required.
  • Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
  • Subjects taking prohibited medications as described in Section 7.7. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: A Phase I Study of N-803 Maintenance Therapy Following CD19 Directed CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (CARMEN-803 Trial)

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.

Being tested
N803
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N803Drug

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

Study groups in NCT07049432
Study groupRoleWhat they receive
N-803ExperimentalParticipants receive N-803 subcutaneously (SubQ) administered on day 1 of each 21-day cycle for up to 6 cycles.
Receives: Drug: N803

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 4 years

  2. 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)

    Measured: 4 years

Secondary outcomes (4)

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

    To assess the rate of conversion from PR to CR at the end of Cycle 6.

    Measured: 2 years

  2. 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.

    To assess the DOR

    Measured: 2 years

  3. 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.

    To assess median and 2-year PFS

    Measured: 2 years

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

    To assess median and 2-year OS

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study startFeb 2026 (estimated)
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2031 (estimated)

Why it stopped: Drug Unavailable

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07049432
Sponsor's protocol ID
HCI189957
Acronym
CARMEN-803
Status last verified
Mar 2026
First submitted
25 Jun 2025
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing N803 in people with B-cell Non Hodgkin Lymphoma, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum tolerated dose (MTD) of N-803 post CAR T-cell therapy (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07049432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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