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NCT04484012 · ClinicalTrials.gov registry record · Phase 2
Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
A Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04484012: Recruiting Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by City of Hope Medical Center.
NCT04484012 is a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 36 participants, roughly in line with the 37-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04484012, a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial investigates the side effects of CD19 chimeric antigen receptor (CAR) T cells and acalabrutinib, and to see how well they work in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CD19, a protein on the surface of the cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19 positive cancer cells. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CD19 CAR T cells together with acalabrutinib may kill more cancer cells.
Primary Outcome
Rates and associated 95% Clopper and Pearson exact confidence interval (CI) will be estimated for DLTs at the safe dose.
Conditions Studied
Interventions
- DRUG Acalabrutinib
- BIOLOGICAL CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes
Study Locations (1)
California
- City of Hope Comprehensive Cancer Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-12-31 |
| Est. Completion | 2026-09-02 |
| Phase | Phase 2 |
What NCT04484012 shows while recruiting
NCT04484012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, roughly in line with the 37-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target.
The record links to 2 conditions, with Recurrent Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Acalabrutinib is the first listed.
NCT04484012 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04484012 about?
NCT04484012 is a clinical study titled "Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma". This phase II trial investigates the side effects of CD19 chimeric antigen receptor (CAR) T cells and acalabrutinib, and to see how well they work in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fightin...
What is the current status of trial NCT04484012?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2020-12-31. Estimated completion is 2026-09-02.
What conditions does trial NCT04484012 study?
This clinical trial studies the following conditions: Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma.
What interventions are being tested in trial NCT04484012?
The interventions under investigation include: Acalabrutinib (DRUG), CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT04484012?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04484012 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Mantle Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04484012's enrollment target sits among peer trials
36 12th of 27 higher than 15 of 27 other Recurrent Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Mantle 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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