Anti-CD19/CD20/CD22 CAR T-Cells for Refractory B-Cell Prolymphocytic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Refractory B-Cell Prolymphocytic Leukemia+25 More
Anti-CD19/CD20/CD22 CAR T-Cells - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Refractory B-Cell Prolymphocytic Leukemia
  • Refractory Transformed Chronic Lymphocytic Leukemia
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent B Acute Lymphoblastic Leukemia
  • B-Cell Lymphomas
  • Recurrent Indolent Non-Hodgkin Lymphoma
  • Lymphoma, Non-Hodgkin
  • B-Lymphocytes
  • Refractory Indolent Non-Hodgkin Lymphoma
  • Refractory Acute Lymphoblastic Leukemia (ALL)
  • chronic, recurrent Lymphocytic Leukemia
  • Lymphoid leukemia
  • Chronic Lymphocytic Leukemia
  • Refractory B Acute Lymphoblastic Leukemia

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 15 years

Year 15
Progression-free survival
Up to 12 months
Presence of measurable CAR-T cells
Month 12
Incidence of adverse events
Up to 15 years
Complete response rate
Correlation between CD19/20/22 expression on disease response
Correlation between cytokine serum concentrations and disease response
Overall response rate
Overall survival
Day 30
Recommended phase II dose of anti-CD19/CD20/CD22 CAR-T cells for each study group (Cohort A and Cohort B)

Trial Safety

Trial Design

2 Treatment Groups

Cohort A (lymphodepletion; anti-CD19/CD20/CD22 CAR-T cells)
1 of 2
Cohort B (lymphodepletion, anti-CD19/CD20/CD22 CAR-T cells)
1 of 2
Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: Anti-CD19/CD20/CD22 CAR T-Cells · No Placebo Group · Phase 1

Cohort A (lymphodepletion; anti-CD19/CD20/CD22 CAR-T cells)Experimental Group · 3 Interventions: Fludarabine Phosphate, Anti-CD19/CD20/CD22 CAR T-Cells, Cyclophosphamide · Intervention Types: Drug, Biological, Drug
Cohort B (lymphodepletion, anti-CD19/CD20/CD22 CAR-T cells)Experimental Group · 3 Interventions: Fludarabine Phosphate, Anti-CD19/CD20/CD22 CAR T-Cells, Cyclophosphamide · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine Phosphate
1997
Completed Phase 3
~2560
Cyclophosphamide
1995
Completed Phase 3
~4020

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
2011First Recorded Clinical Trial
2 TrialsResearching Refractory B-Cell Prolymphocytic Leukemia
206 CompletedClinical Trials

Who is running the clinical trial?

Sumithira VasuLead Sponsor
4 Previous Clinical Trials
52 Total Patients Enrolled
Sumithira Vasu, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The patient's lymphoid malignancy must be positive for CD19 and/or CD20 and/or CD22, either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.
Subjects with relapsed/refractory B-prolymphocytic leukemia who have received at least 1- 2 prior lines of appropriate therapy and who have failed or are ineligible for allogeneic stem cell transplant are eligible for this study.
Subjects with relapsed/refractory acute B-lymphoblastic leukemia who have received at least 2 prior lines of appropriate therapy or who have failed or are ineligible for allogeneic stem cell transplant.
Patients who received blinatumomab or inotuzumab are eligible.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.