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
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) or diffuse large B-cell lymphoma (DLBCL) or related subtypes
- Relapsed or refractory disease defined by lack of response or progression within 6 months of last therapy
- CD19-positive B-cell malignancy confirmed
- Detectable residual disease before CAR T-cell infusion
- DLBCL patients must have had 2 or more prior chemoimmunotherapy regimens including anthracycline and CD20 therapy, except Richter syndrome patients who need at least 1 prior regimen
- Presence of at least one PET-avid measurable lesion for DLBCL
- Biopsy confirmation of relapsed or refractory DLBCL required
- B-ALL patients must have at least 5% bone marrow involvement or one PET-avid measurable extramedullary lesion
- Age 18 years or older
- Creatinine clearance of at least 50 mL/min
- Liver function within specified limits unless due to underlying malignancy
- Adequate lung function with oxygen saturation at least 92% on room air
- Adequate bone marrow function without recent blood support unless due to malignancy
- ECOG performance status between 0 and 2
You will not qualify if you...
- ECOG performance status 3 or higher
- Pregnant or breastfeeding; contraception required during and for 1 year after treatment
- Impaired heart 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 class III or IV heart failure, recent heart attack within 6 months, serious ventricular arrhythmias, or severe cardiomyopathy
- Positive HIV or active hepatitis B or C infections, with exceptions for vaccinated or controlled cases
- Uncontrolled systemic infections
- Other active cancers needing treatment besides certain skin cancers
- Significant neurological disorders such as epilepsy or severe brain injuries
- Presence of human anti-mouse antibodies to BC8
- Any other medical condition judged by the doctor to prevent safe participation
AI-Screening
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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
CONTACT
S
Somali Gavane, MD
CONTACT
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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