Chimeric Antigen Receptor T-Cell Therapy for Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Lymphoblastic Leukemia+6 MoreChimeric Antigen Receptor T-Cell Therapy - Biological
Eligibility
1 - 30
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the efficacy of CD19/CD22-CAR T cells in treating children with B-cell acute lymphoblastic leukemia that has returned or is unresponsive to treatment.

Eligible Conditions
  • Acute Lymphoblastic Leukemia
  • Philadelphia Chromosome Positive
  • Minimal Residual Disease
  • Acute Lymphoblastic Leukemia (ALL)
  • Childhood Acute Lymphoblastic Leukemia (ALL)
  • Refractory Acute Lymphoblastic Leukemia
  • CD19 Positive B Cell Acute Lymphoblastic Leukemia

Treatment Effectiveness

Study Objectives

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

Day 14
Rate of successful manufacture and expansion of the CD19/CD22 chimeric antigen receptor (CAR) T cells to satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (COA)
Up to 15 years
Alterations in early B cell development induced by immune pressure exerted via CD19/CD22-CAR T cells
CD19/CD22 chimeric antigen receptor (CAR) T cell properties
Frequency of CD22+ expression on lymphoma cells
Persistence of CD19/CD22 chimeric antigen receptor (CAR) T cells blood, bone marrow, and cerebral spinal fluid (CSF)
Relapse with loss or diminished expression of CD19 and/or CD22
The ability to achieve a clinical response after administration of CD19/CD22 chimeric antigen receptor (CAR) T cells
Up to 28 days
Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/CD22 chimeric antigen receptor (CAR) T cells

Trial Safety

Trial Design

1 Treatment Group

Treatment (CD19/CD22-CAR T cells, chemotherapy)
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Chimeric Antigen Receptor T-Cell Therapy · No Placebo Group · Phase 1

Treatment (CD19/CD22-CAR T cells, chemotherapy)Experimental Group · 5 Interventions: Cyclophosphamide, Chimeric Antigen Receptor T-Cell Therapy, Laboratory Biomarker Analysis, Fludarabine Phosphate, Questionnaire Administration · Intervention Types: Drug, Biological, Other, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years

Who is running the clinical trial?

Crystal Mackall, MDLead Sponsor
4 Previous Clinical Trials
171 Total Patients Enrolled
Crystal MackallPrincipal Investigator - Stanford University
Stanford University

Eligibility Criteria

Age 1 - 30 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects with lymphoma must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti CD20 monoclonal antibody.
Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs).
Subjects who have undergone autologous SCT with disease progression or relapse following SCT will be eligible if all other eligibility criteria are met.
Subjects with persistent or relapsed minimal residual disease (MRD) (by flow cytometry, PCR, FISH, or next generation sequencing) require verification of MRD positivity on two occasions at least 4 weeks apart.
Subjects with recurrence of isolated CNS relapse after achieving complete remission (CR); if relapsed with MRD, will require verification of MRD positivity on two occasions at least 4 weeks apart.