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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 131-I Apamistamab

    Drug

    Patients will receive 131-I apamistamab 5-7 days prior to a single infusion of 1x10\^6 19-28z CAR T-cells/kg for those in the B-ALL cohort, or 2x10\^6 19-28z CAR T-cells/kg, for those in the DLBCL. 131-I apamistamab may be administered inpatient or outpatient at the discretion and judgment of the treating investigators.

  • CAR T-cell

    Biological/Vaccine

    19-28z CAR T-cells will be administered inpatient as a single infusion of 1x10\^6 19-28z CAR T-cells/kg, for those in the B-ALL cohort, or 2x10\^6 19-28z CAR T-cells/kg, for those in the DLBCL cohort. Patients will be observed inpatient for a minimum of 7 days (longer as clinically indicated and at the discretion of the treating physician).

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: B-Cell Acute Lymphoblastic Leukemia/Diffuse Large B-Cell LymExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting toxicities and maximum tolerated dose of 131-I apamistamab, when given in combination with 19-28z CAR T-cells for treatment of relapsed or refractory B-cell ALL or DLBCL

To determine the safety and tolerability of a single dose of 131-I apamistamab given prior to 19-28z CAR T-cell infusion in patients with relapsed or refractory B-cell ALL or DLBCL.

Time frame
30 days after treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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