OncoMatch/Clinical Trials/NCT04512716
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
Is NCT04512716 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including CAR T-cell and 131-I Apamistamab for b-all.
Treatment: 131-I Apamistamab · CAR T-cell — This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive
patients must have a CD19+ B-cell malignancy ... CD19 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemoimmunotherapy (anthracycline, CD20-directed therapy) — DLBCL/HGBL: at least 2 prior regimens (Richter syndrome: at least 1 prior regimen)
relapsed or refractory DLBCL or high-grade B-cell lymphoma (HGBL) following 2 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy)... Exception: patients with Richter syndrome ... are eligible following 1 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy)
Must have received: multi-agent chemotherapy — B-cell ALL, Ph-negative: at least 1 line of multi-agent chemotherapy including induction and consolidation
Philadelphia chromosome-negative B-cell ALL must have been refractory to at least 1 line of multi-agent chemotherapy or relapsed following at least 1 prior multiagent systemic chemotherapy regimen that included induction and consolidation therapy
Must have received: second- or third-generation tyrosine kinase inhibitor — Ph-positive ALL or CML in lymphoid blast crisis: persistent disease after TKI
Philadelphia chromosome-positive ALL or CML in lymphoid blast crisis must have exhibited persistent disease following therapy with a second- or third-generation tyrosine kinase inhibitor
Lab requirements
Blood counts
Absolute neutrophil count ≥0.5k/µL, Platelets ≥30k/µL, Hemoglobin ≥7g/dL (without requiring blood product or G-CSF support in past 7 days, unless cytopenias attributed to underlying malignancy)
Kidney function
Creatinine clearance ≥50 mL/min as calculated by the Cockroft-Gault formula
Liver function
Direct bilirubin ≤2.0 mg/dL, AST and ALT ≤3.0x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy
Cardiac function
LVEF ≥40% by echocardiogram or MUGA; exclusion for NYHA stage III/IV CHF, MI ≤6 months, history of significant ventricular arrhythmia or unexplained syncope, severe non-ischemic cardiomyopathy with LVEF ≤20%
Creatinine clearance ≥50 mL/min ... Direct bilirubin ≤2.0 mg/dL, AST and ALT ≤3.0x ULN ... Adequate bone marrow function ... LVEF ≥40% ... see cardiac exclusion criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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