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NCT04892277 · ClinicalTrials.gov registry record · Phase 1

CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies

A Phase 1 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 1
Development phase
25
Enrollment target
1
Study location

NCT04892277: Recruiting Phase 1 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, sponsored by Mayo Clinic.

NCT04892277 is a Phase 1 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 25 participants, below the 48-participant average among 20 other Recurrent Chronic Lymphocytic Leukemia trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04892277, a Phase 1 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 1
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19/1563 treatment. IC19/1563 may help treat patients with relapsed/refractory B cell malignancies.

Primary Outcome

MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • DRUG Bendamustine
  • BIOLOGICAL Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563

Study Locations (1)

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2022-10-03
Est. Completion 2040-03-27
Phase Phase 1
Mayo Clinic

2,844 total trials

What NCT04892277 shows while recruiting

NCT04892277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 48-participant average among 20 other Recurrent Chronic Lymphocytic Leukemia trials with a reported enrollment target (48% lower).

The record links to 8 conditions, with Recurrent Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04892277 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT04892277 about?

NCT04892277 is a clinical study titled "CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies". This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, ...

What is the current status of trial NCT04892277?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-10-03. Estimated completion is 2040-03-27.

What conditions does trial NCT04892277 study?

This clinical trial studies the following conditions: Recurrent Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory B-Cell Non-Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma.

What interventions are being tested in trial NCT04892277?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Bendamustine (DRUG), Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04892277?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04892277 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Recurrent Chronic Lymphocytic Leukemia

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 NCT04892277's enrollment target sits among peer trials

25 10th of 20 higher than 11 of 20 other Recurrent Chronic Lymphocytic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Chronic Lymphocytic Leukemia 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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Source: ClinicalTrials.gov NCT04892277, the US trial registry maintained by the National Library of Medicine. NCT04892277 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.