Autologous CD19/CD22 Chimeric Antigen Receptor T-cells for Minimal Residual Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Minimal Residual Disease+18 More
Autologous CD19/CD22 Chimeric Antigen Receptor T-cells - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a new treatment for cancer, in which T-cells are collected from the patient, modified with a new genetic material, and then infused back into the patient's body.

Eligible Conditions
  • Minimal Residual Disease
  • Lymphoma, Non-Hodgkin
  • Progressive Disease
  • CD22 Positive
  • Refractory B Acute Lymphoblastic Leukemia
  • CD19 Positive
  • Recurrent B Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
  • chronic, recurrent Lymphocytic Leukemia

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Up to 1 year post T-cell infusion

Day 30
Efficacy in complete response (CR) or partial response
Year 1
Immune reconstitution
Overall survival
Persistence of CAR T-cells
Progression-free survival
Up to 30 days
Incidence of adverse events (adverse events)
Optimal chimeric antigen receptor (CAR) T cell dose level

Trial Safety

Trial Design

1 Treatment Group

Treatment (CD19-CD22 CAR T cells)
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells · No Placebo Group · Phase 1 & 2

Treatment (CD19-CD22 CAR T cells)Experimental Group · 3 Interventions: Fludarabine, Autologous CD19/CD22 Chimeric Antigen Receptor T-cells, Cyclophosphamide · Intervention Types: Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year post t-cell infusion

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,780 Previous Clinical Trials
1,784,780 Total Patients Enrolled
6 Trials studying Minimal Residual Disease
165 Patients Enrolled for Minimal Residual Disease
National Cancer Institute (NCI)NIH
12,995 Previous Clinical Trials
41,299,906 Total Patients Enrolled
11 Trials studying Minimal Residual Disease
379 Patients Enrolled for Minimal Residual Disease
Jin S ImPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Total bilirubin less than 1.
You have no evidence of cardiac tamponade as determined by echocardiogram (ECHO) or multigated acquisition scan (MUGA), no clinical significant electrocardiogram (ECG) findings.
Patients may have received last cytotoxic chemotherapy at least 3 weeks prior to lymphodepleting chemotherapy.
You have a disease that is CD19 and/or CD22 positive by flow cytometry or immunohistochemistry.
You have a Karnofsky/Lansky performance scale > 70.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 5th, 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.