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NCT07335328 · ClinicalTrials.gov registry record · Phase 1
Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Not yet
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT07335328: Clinical Trial Phase 1 study, sponsored by Medical College of Wisconsin.
NCT07335328 is a Phase 1 study that has not yet begun recruiting, run by Medical College of Wisconsin. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07335328, a Phase 1 study, has not yet begun recruiting, sponsored by Medical College of Wisconsin.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.
Primary Outcome
The maximum tolerated dose (MTD) is the highest dose of a drug or treatment that does not cause dose-limiting toxicities (DLTs). This trial will utilize a 3+3 design to determine the safe dose. Three patients are enrolled and treated at the starting (lowest) dose level. * 0 DLTs: If none of the three patients experience a DLT, the next cohort of three patients is treated at the next higher dose level. * 1 DLT: If one patient experiences a DLT, an additional three patients are enrolled at the sa
Interventions
- BIOLOGICAL 1 X 10^6 cells/kg
- BIOLOGICAL 2.5 X 10^6 cells/kg
- BIOLOGICAL Dose expansion: The maximum tolerated dose of CAR-T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2031-05-01 |
| Phase | Phase 1 |
What is known before NCT07335328 opens enrollment
NCT07335328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which 1 X 10^6 cells/kg is the first listed.
NCT07335328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07335328 about?
NCT07335328 is a clinical study titled "Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies". This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.
What is the current status of trial NCT07335328?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2026-09-01. Estimated completion is 2031-05-01.
What interventions are being tested in trial NCT07335328?
The interventions under investigation include: 1 X 10^6 cells/kg (BIOLOGICAL), 2.5 X 10^6 cells/kg (BIOLOGICAL), Dose expansion: The maximum tolerated dose of CAR-T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT07335328?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07335328's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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