CAR-20/19-T cells for Acute Lymphoblastic Leukemia (ALL)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Lymphoblastic Leukemia (ALL)+5 MoreCAR-20/19-T cells - Biological
Eligibility
1 - 39
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study a new cancer treatment involving CAR-T cells, which are genetically modified to target and destroy cancer cells. The safety and effectiveness of this treatment will be evaluated in patients with B cell acute lymphoblastic leukemia.

Eligible Conditions
  • Acute Lymphoblastic Leukemia Recurrent
  • Acute Lymphoblastic Leukemia With Relapsed/Refractory Disease
  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Lymphoblastic Leukemia Not in Remission
  • Acute Lymphoblastic Leukemia (ALL) in Relapse

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: 40 months

28 days after infusion
Number of Adverse Events after CAR 20/19-T Cell Infusion.
40 months
Describe the duration of response for responding patients.
Determine persistence of CAR-20/19-T cells.
Determine the anti-tumor responses as measured by response rates.
Determine the effects of CAR-20/19-T infusion on non-neoplastic CD19 & CD20 B cells in vivo.
Determine the feasibility to manufacture CAR-20/19-T cells locally from pediatric and young adult apheresis products using the CliniMACS Prodigy Cell processing device.
Determine the safety (dose level) of CAR-20/19-T cell administration in relapsed refractory B-ALL.
Evaluate MRD using molecular technologies.

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Dose Escalation Phase
1 of 6
2.5 x10^5 CAR-20/19-T cells/kg
1 of 6
7.5 x10^5 CAR-20/19-T cells/kg
1 of 6
2.5 x10^6 CAR-20/19-T cells/kg
1 of 6
1 x 10^5 CAR-20/19-T cells/kg
1 of 6
Dose Expansion Phase
1 of 6

Experimental Treatment

24 Total Participants · 6 Treatment Groups

Primary Treatment: CAR-20/19-T cells · No Placebo Group · Phase 1

Dose Escalation Phase
Biological
Experimental Group · 1 Intervention: CAR-20/19-T cells · Intervention Types: Biological
2.5 x10^5 CAR-20/19-T cells/kg
Biological
Experimental Group · 1 Intervention: CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg) · Intervention Types: Biological
7.5 x10^5 CAR-20/19-T cells/kg
Biological
Experimental Group · 1 Intervention: CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg) · Intervention Types: Biological
2.5 x10^6 CAR-20/19-T cells/kg
Biological
Experimental Group · 1 Intervention: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg) · Intervention Types: Biological
1 x 10^5 CAR-20/19-T cells/kg
Biological
Experimental Group · 1 Intervention: CAR-20/19-T cells (1 x 10^5 CAR-20/19-T cells/kg) · Intervention Types: Biological
Dose Expansion PhaseExperimental Group · 5 Interventions: CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells, CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg), CAR-20/19-T cells (1 x 10^5 CAR-20/19-T cells/kg) · Intervention Types: Biological, Biological, Biological, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg)
2017
Completed Phase 1
~30
CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg)
2017
Completed Phase 1
~30
CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)
2017
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 40 months

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
566 Previous Clinical Trials
1,154,136 Total Patients Enrolled
7 Trials studying Acute Lymphoblastic Leukemia (ALL)
2,706 Patients Enrolled for Acute Lymphoblastic Leukemia (ALL)
Children's Hospital and Health System Foundation, WisconsinOTHER
53 Previous Clinical Trials
96,125 Total Patients Enrolled
Julie-An Talano, MDPrincipal InvestigatorMedical College of Wisconsin
2 Previous Clinical Trials
85 Total Patients Enrolled

Eligibility Criteria

Age 1 - 39 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects with B-cell ALL must have either CD19 or CD20 positive disease on their most recent bone marrow performed.
Subjects must be aged ≥1 year and ≤ 39 years with relapsed, refractory disease and no available curative options that meet clinical criteria to initiate treatment.
You have a primary refractory disease.
You have had two or more lines of systemic therapy for your disease.
The CD3+ T cell count in the peripheral blood is greater than 100/mm^3.