Actively Recruiting
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
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-17
12
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 131-I apamistamab followed by CD19-targeted CAR T-cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) or diffuse large B-cell lymphoma (DLBCL). This pilot trial aims to determine the maximum tolerated dose of 131-I apamistamab when given before CAR T-cell infusion and to assess the safety of a lower dose if the higher dose is not tolerated. The study is conducted by Memorial Sloan Kettering Cancer Center and is an early phase trial focused on these blood cancers. Patients will receive an infusion of 131-I apamistamab 5 to 7 days before a single infusion of CAR T-cells. The CAR T-cell dose varies by disease type: 1 million CAR T-cells per kilogram for B-ALL and 2 million per kilogram for DLBCL. The 131-I apamistamab may be given as an inpatient or outpatient treatment based on investigator discretion. After the CAR T-cell infusion, patients will be monitored as inpatients for at least 7 days or longer if clinically needed. Participants will be closely observed throughout the trial with assessments including monitoring for dose-limiting toxicities and determining the maximum tolerated dose within 30 days after treatment. The study involves detailed eligibility screening, including disease status and organ function tests. Researchers will track safety and treatment effects, and participation may last until the primary outcomes are evaluated, with follow-up as clinically indicated. The study excludes patients with certain infections, cardiac conditions, or other health issues that could affect safety.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have relapsed or refractory B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma or their subtypes
- Refractory disease defined as failure to achieve at least partial response or disease progression within 6 months of last therapy
- Detectable residual malignancy at assessment prior to CAR T-cell infusion
- For DLBCL: relapsed or refractory disease after 2 or more prior chemoimmunotherapy regimens (1 including anthracycline and CD20 therapy), with at least one FDG-avid measurable lesion and biopsy confirmation
- For B-ALL: refractory to at least 1 line of multi-agent chemotherapy or relapsed after prior chemotherapy, with 5% or more bone marrow involvement or at least one FDG-avid measurable extramedullary lesion
- CD19 expression confirmed prior to enrollment
- Age 18 years or older
- Creatinine clearance 50 mL/min or higher
- Direct bilirubin 2.0 mg/dL or less, AST and ALT no more than 3 times upper limit of normal unless liver dysfunction related to malignancy
- Adequate pulmonary function with oxygen saturation 92% or higher on room air
- Adequate bone marrow function without recent blood product or growth factor support unless due to malignancy
- ECOG performance status 0 to 2
You will not qualify if you...
- ECOG performance status 3 or higher
- Pregnant or lactating patients; effective contraception required during and for 1 year after treatment
- Impaired cardiac function with left ventricular ejection fraction below 40%
- Active graft versus host disease needing systemic T-cell suppressive therapy
- Active autoimmune disease requiring systemic T-cell suppressive therapy
- Severe cardiac conditions including NYHA stage III or IV heart failure, recent myocardial infarction within 6 months, significant ventricular arrhythmia or unexplained syncope, severe non-ischemic cardiomyopathy with LVEF below 20%
- Positive tests for HIV or hepatitis B or C with exceptions for vaccinated or resolved infection
- Uncontrolled systemic infections
- Concurrent active malignancies requiring therapy other than observation or hormonal therapy, except certain skin cancers
- Clinically significant neurological disorders such as epilepsy or severe brain injury
- Presence of circulating human anti-mouse antibodies to BC8
- Any other condition deemed by the physician to make the patient ineligible for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive 131-I apamistamab 5-7 days prior to a single infusion of CD19-targeted CAR T-cells. 131-I apamistamab may be given inpatient or outpatient, and CAR T-cell infusion occurs inpatient with observation for at least 7 days.
1 inpatient admission for CAR T-cell infusion and at least 7 days of observation; 131-I apamistamab administered 5-7 days prior (inpatient or outpatient)
Duration - 30 days after treatment
Participants are monitored for dose-limiting toxicities and treatment outcomes for 30 days after treatment.
Visits as needed for safety monitoring during this period
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
M
Mark B Geyer, MD
S
Somali Gavane, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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