Trial Summary
What is the purpose of this trial?In this protocol, the investigators hypothesize that modifying the process of producing CAR+ T-cells can help to improve responses and reduce toxicities. Building on previous in vitro studies that have shown successful production of CAR+ T-cells using a new production approach, the investigators are now studying the ability to produce these CAR+ T-cells and determine how well they work in the clinical setting.
Eligibility Criteria
Adults over 18 with certain aggressive B-cell blood cancers that have come back or didn't respond to treatment. They must be in good physical shape, with well-functioning organs and bone marrow. Pregnant women can't join, and participants should not have severe heart issues, active infections like HIV/HBV/HCV, a history of significant autoimmune diseases within the last two years, or any recent serious allergic reactions to similar drugs.Inclusion Criteria
It's been over 2 weeks or 5 half-lives since my last systemic therapy, except for immune therapy.
My B-ALL cancer has not responded to treatment or has come back.
My aggressive B cell NHL has come back or is not responding to treatment.
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Exclusion Criteria
I haven't had a heart attack or other major heart issues in the last year.
I have been cancer-free for at least a year, except for non-melanoma skin cancer or certain in situ cancers.
I do not have any active infections.
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Participant Groups
The trial is testing a new way to make CAR T-cells using CD19-CD34 proteins. These are special immune cells designed in the lab to fight cancer better and with fewer side effects than previous methods. Patients will also receive chemotherapy drugs Cyclophosphamide and Fludarabine before getting these modified T-cells.
4Treatment groups
Experimental Treatment
Group I: CAR 5 x 105 transduced T cells/kg (Dose Level -1)Experimental Treatment3 Interventions
Autologous peripheral blood mononuclear cell (PBMC) will be obtained by leukapheresis over one day. Daily intravenous (IV) infusion of fludarabine and cyclophosphamide for total of 3 days (Days -5, -4, -3). The dose of cyclophosphamide will be given at 500mg/m2. The dose of fludarabine will be given at 30mg/m2. CD19-CD34 CAR transduced T cells will be administered IV at a dose level of 5 x 105 transduced T cells/kg.
Group II: CAR 2 x 106 transduced T cells/kg (Dose Level 3)Experimental Treatment3 Interventions
Autologous peripheral blood mononuclear cell (PBMC) will be obtained by leukapheresis over one day. Daily intravenous (IV) infusion of fludarabine and cyclophosphamide for total of 3 days (Days -5, -4, -3). The dose of cyclophosphamide will be given at 500mg/m2. The dose of fludarabine will be given at 30mg/m2. CD19-CD34 CAR transduced T cells will be administered IV at a dose level of 2 x 106 transduced T cells/kg.
Group III: CAR 1.5 x 106 transduced T cells/kg (Dose Level 2)Experimental Treatment3 Interventions
Autologous peripheral blood mononuclear cell (PBMC) will be obtained by leukapheresis over one day. Daily intravenous (IV) infusion of fludarabine and cyclophosphamide for total of 3 days (Days -5, -4, -3). The dose of cyclophosphamide will be given at 500mg/m2. The dose of fludarabine will be given at 30mg/m2. CD19-CD34 CAR transduced T cells will be administered IV at a dose level of 1.5 x 106 transduced T cells/kg.
Group IV: CAR 1 x 106 transduced T cells/kg (Dose Level 1)Experimental Treatment3 Interventions
Autologous peripheral blood mononuclear cell (PBMC) will be obtained by leukapheresis over one day. Daily intravenous (IV) infusion of fludarabine and cyclophosphamide for total of 3 days (Days -5, -4, -3). The dose of cyclophosphamide will be given at 500mg/m2. The dose of fludarabine will be given at 30mg/m2. CD19-CD34 CAR transduced T cells will be administered IV at a dose level of 1 x 106 transduced T cells/kg.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Loyola UniversityMaywood, IL
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Who Is Running the Clinical Trial?
Loyola UniversityLead Sponsor
Leukemia Research FoundationCollaborator