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NCT05418088 · ClinicalTrials.gov registry record · Phase 1

Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies

A Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Chronic Lymphocytic Leukemia, sponsored by Sumithira Vasu.

Recruiting
Registry status
Phase 1
Development phase
54
Enrollment target
2
Study locations

NCT05418088: Recruiting Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Chronic Lymphocytic Leukemia, sponsored by Sumithira Vasu.

NCT05418088 is a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Chronic Lymphocytic Leukemia that is actively recruiting participants, run by Sumithira Vasu. The registered enrollment target is 54 participants, above the 42-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (29% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05418088, a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by Sumithira Vasu.

RECRUITING
Registry status
Phase 1
Development phase
54 participants
Enrollment target
2
Study locations

Study Summary

This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19/CD20/CD22 which are found on the surface of cancer cells. Anti-CD19/CD20/CD22 CAR T-cells can recognize CD19/CD20/CD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells.

Conditions Studied

Refractory Acute Lymphoblastic Leukemia Recurrent Chronic Lymphocytic Leukemia Recurrent Acute Lymphoblastic Leukemia Recurrent B Acute Lymphoblastic Leukemia Recurrent Non-Hodgkin Lymphoma Recurrent Transformed Chronic Lymphocytic Leukemia Refractory B Acute Lymphoblastic Leukemia Recurrent High Grade B-Cell Lymphoma Recurrent Indolent Non-Hodgkin Lymphoma Recurrent B-Cell Prolymphocytic Leukemia

Interventions

  • DRUG Cyclophosphamide
  • PROCEDURE Echocardiography
  • DRUG Fludarabine Phosphate
  • PROCEDURE Multigated Acquisition Scan
  • BIOLOGICAL Anti-CD19/CD20/CD22 CAR T-Cells

Study Locations (2)

Ohio

  • Nationwide Children's Hospital - Columbus
  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2022-06-30
Est. Completion 2026-07-31
Phase Phase 1
Sumithira Vasu

6 total trials

What NCT05418088 shows while recruiting

NCT05418088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, above the 42-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (29% higher).

The record links to 10 conditions, with Refractory Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT05418088 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT05418088 about?

NCT05418088 is a clinical study titled "Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies". This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malig...

What is the current status of trial NCT05418088?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2022-06-30. Estimated completion is 2026-07-31.

What conditions does trial NCT05418088 study?

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

What interventions are being tested in trial NCT05418088?

The interventions under investigation include: Cyclophosphamide (DRUG), Echocardiography (PROCEDURE), Fludarabine Phosphate (DRUG), Multigated Acquisition Scan (PROCEDURE), Anti-CD19/CD20/CD22 CAR T-Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT05418088?

This trial is sponsored by Sumithira Vasu, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05418088 being conducted?

This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Refractory Acute Lymphoblastic 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 NCT05418088's enrollment target sits among peer trials

54 6th of 21 higher than 16 of 21 other Refractory Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Acute Lymphoblastic 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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More recruiting context for NCT05418088

Source: ClinicalTrials.gov NCT05418088, the US trial registry maintained by the National Library of Medicine. NCT05418088 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.