autologous CD19-directed chimeric antigen receptor (CAR) T-cells for Non-Hodgkin's Lymphoma, Relapsed

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Hodgkin's Lymphoma, Relapsed+2 Moreautologous CD19-directed chimeric antigen receptor (CAR) T-cells - Biological
Eligibility
2 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to treat cancer using the patient's own immune cells.

Eligible Conditions
  • Acute Lymphoblastic Leukemia (ALL)
  • Relapsed Pediatric Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma, Relapsed

Treatment Effectiveness

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: 3 years

3 years
Area-Under-the-Concentration-vs-time curve (AUC) in peripheral blood and/or bone marrow.
Maximum concentration (Cmax).
Number and type of treatment-related adverse events.
Number of dose limiting toxicities of anti-CD19 CAR T-cells
Overall objective response rate (ORR: proportion of patients with confirmed responses of complete [CR] or partial [PR])
Time to maximum concentration (Tmax).

Trial Safety

Trial Design

1 Treatment Group

CAR T cells
1 of 1

Experimental Treatment

63 Total Participants · 1 Treatment Group

Primary Treatment: autologous CD19-directed chimeric antigen receptor (CAR) T-cells · No Placebo Group · Phase 1 & 2

CAR T cells
Biological
Experimental Group · 1 Intervention: autologous CD19-directed chimeric antigen receptor (CAR) T-cells · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

University of AlbertaLead Sponsor
817 Previous Clinical Trials
376,555 Total Patients Enrolled
Alberta Cancer FoundationOTHER
17 Previous Clinical Trials
5,612 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
114 Previous Clinical Trials
65,852 Total Patients Enrolled
Dr. Michael P Chu, MDPrincipal InvestigatorCross Cancer Institute

Eligibility Criteria

Age 2 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Tumor tissue must be available for correlative laboratory studies.
You have histologically or cytologically documented, CD19+ non-hodgkin's lymphoma or ALL.
Male participants should agree to not donate sperm during study period (i.e.