RecruitingEarly Phase 1NCT04512716

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

12 participants

Start Date

Feb 2, 2021

Study Type

INTERVENTIONAL

Conditions

B-ALL DLBCL

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a targeted radiation treatment (using a radioactive antibody called iomab-ACT / 131-I apamistamab) to clear out the bone marrow can improve the success of CAR T cell therapy for relapsed or treatment-resistant B-cell leukemia (B-ALL) or diffuse large B-cell lymphoma (DLBCL). **You may be eligible if...** - You have been diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) or diffuse large B-cell lymphoma (DLBCL) — including certain subtypes - Your cancer has relapsed (come back) or is refractory (not responding to treatment) - You have received prior therapy but it was not successful - You are in adequate health to undergo CAR T cell therapy **You may NOT be eligible if...** - You have active brain involvement of your cancer - You have had a prior solid organ transplant - You have serious heart, kidney, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG131-I Apamistamab

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.

BIOLOGICALCAR T-cell

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).