N-803 Maintenance Therapy Post CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell … (NCT07049432) | Clinical Trial Compass
WithdrawnPhase 1
N-803 Maintenance Therapy Post CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas
Stopped: Drug Unavailable
United States0Started 2026-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
* 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 h…
What they're measuring
1
The maximum tolerated dose (MTD) of N-803 post CAR T-cell therapy
Timeframe: 4 years
2
Determination of a dose level for the phase 2 study (RP2D) of N-803 post CAR T-cell Therapy