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

Locations

7
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645, MontvaleNew Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)11725, CommackNew York, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov