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NCT04512716 · ClinicalTrials.gov registry record · Early 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
A Early Phase 1 study of Diffuse Large B Cell Lymphoma and DLBCL, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 7
- Study locations
NCT04512716: Recruiting Early Phase 1 study of Diffuse Large B Cell Lymphoma and DLBCL, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04512716 is a Early Phase 1 study of Diffuse Large B Cell Lymphoma and DLBCL that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 12 participants, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04512716, a Early Phase 1 study of Diffuse Large B Cell Lymphoma and DLBCL, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 131-I Apamistamab
- BIOLOGICAL CAR T-cell
Study Locations (7)
New York
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) - Rockville Centre
New Jersey
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-02-02 |
| Est. Completion | 2027-01 |
| Phase | Early Phase 1 |
What NCT04512716 shows while recruiting
NCT04512716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (95% lower).
The record links to 9 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which 131-I Apamistamab is the first listed.
NCT04512716 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04512716 about?
NCT04512716 is a clinical study titled "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". 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.
What is the current status of trial NCT04512716?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2021-02-02. Estimated completion is 2027-01.
What conditions does trial NCT04512716 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, DLBCL, B-ALL, DLBCL, Nos Genetic Subtypes, Dlbcl-Ci.
What interventions are being tested in trial NCT04512716?
The interventions under investigation include: 131-I Apamistamab (DRUG), CAR T-cell (BIOLOGICAL).
Who is sponsoring clinical trial NCT04512716?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04512716 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04512716's enrollment target sits among peer trials
12 104th of 114 higher than 9 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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