RecruitingEarly Phase 1

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

United States12 participantsStarted 2021-02-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Absolute neutrophil count ≥0.5k/µL,
✓. Platelets ≥30k/µL,
✓. Hemoglobin ≥7g/dL.

Exclusion criteria

✕. New York Heart Association (NYHA) stage III or IV congestive heart failure
✕. Myocardial infarction ≤6 months prior to enrollment
✕. Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
✕. Any history of severe non-ischemic cardiomyopathy with LVEF ≤20%
✕. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded.
✕. Subjects who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded.

What they're measuring

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

Timeframe: 30 days after treatment

Trial details

NCT IDNCT04512716

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Mark B Geyer, MD

646-608-3745 geyerm@mskcc.org

View on ClinicalTrials.gov More B-ALL trials