Health Trials

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

ConditionsB-ALLDLBCLB ALLDlbcl-CiDLBCL UnclassifiableDLBCL, Nos Genetic SubtypesDLBCL Activated B-Cell TypeDLBCL Germinal Center B-Cell TypeDiffuse Large B-cell LymphomaHGBLHGBL, Nos
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

While prior CD19-targeted therapies, including CAR T-cell therapy, do not exclude participation, CD19 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment.

Age ≥ 18 years of age

Creatinine clearance ≥50 mL/min as calculated by the Cockroft-Gault formula

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

Disqualifiers

ECOG performance status ≥3.

Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.

Impaired cardiac function (LVEF <40%) as assessed by echocardiogram or MUGA scan during screening

Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible

Trial design

Treatments tested in this trial

  • 131-I Apamistamab
  • CAR T-cell

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov