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Iomab-ACT: 131-I Apamistamab and CAR T-Cell Therapy for B-Cell ALL or DLBCL

This pilot study is testing a new approach for adults with B-cell Acute Lymphoblastic Leukemia (B-ALL) or Diffuse Large B-Cell Lymphoma (DLBCL) that has come back or is not responding to treatment. You would receive a drug called 131-I apamistamab, followed by a single infusion of CAR T-cells (a type of immunotherapy where your own immune cells are specially trained to fight cancer). The main goal is to find the safest dose of 131-I apamistamab when given with CAR T-cells. This study is currently recruiting about 12 participants, but the overall status is unclear.

Study design
This is a pilot study involving about 12 participants. It is an interventional study, meaning participants will receive specific treatments.
What's involved
You would receive 131-I apamistamab 5-7 days before a single infusion of CAR T-cells. You would be observed in the hospital for at least 7 days after the CAR T-cell infusion.
Compensation
Not stated in the trial record.
Follow-up
The primary safety outcomes will be measured 30 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04512716

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~12 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:131-I ApamistamabCAR T-cell

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
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
Measured over 30 days after treatment

Conditions

B-ALL
DLBCL
B ALL
Dlbcl-Ci
DLBCL Unclassifiable
DLBCL, Nos Genetic Subtypes
DLBCL Activated B-Cell Type
DLBCL Germinal Center B-Cell Type
Diffuse Large B-cell Lymphoma
HGBL
HGBL, Nos

Explore related trials

B Acute Lymphoblastic LeukemiaDiffuse Large B-Cell LymphomaHematologic NeoplasmCD19 Gene

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Mark B Geyer, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Mark B Geyer, MD
[email protected]
646-608-3745
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the past 7 days, unless cytopenias are attributed to underlying malignancy in the opinion of the investigator:
ECOG performance status 0-2.

Exclusion

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
Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible
Patients with following cardiac conditions will be excluded:
Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:
Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible.
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.
Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.
Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.
Patients with circulating human anti-mouse antibodies to BC8 noted on initial screening (see Appendix III)

What this trial measures

  • 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 DLBCL30 days after treatment

    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.