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CAR T-cell Therapy

CAR-T Therapy for Leukemia

Phase 1 & 2
Waitlist Available
Led By Bachanova Veronika, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function: Renal: Calculated estimated glomerular filtration rate ≥50 mL/min/1.73 m2, Hepatic: ALT and AST < 3x upper limit of normal, bilirubin < 2x upper limit of normal, Cardiac: Left ventricular ejection fraction (LVEF) > 45%, Pulmonary: SpO2 > 92% on room air
Diagnosis of R/R CD19+ B-ALL after failure of standard of care therapies with CD19 expression on blasts confirmed by flow cytometry or immunohistochemistry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is designed to study the safety and efficacy of CAR19-tTreg cells in patients with relapsed or refractory CD19+ B-ALL.

Who is the study for?
Adults with relapsed/refractory CD19+ B-ALL who've failed standard treatments can join this trial. They must have a certain level of organ function, not be on recent immunosuppressives or investigational drugs, and cannot be pregnant or breastfeeding. Those with active infections, severe heart conditions, allergies to specific manufacturing components, or available FDA-approved CAR T cell therapy are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of allogeneic CAR19 regulatory T cells (CAR19-tTreg) in adults with stubborn leukemia that hasn't responded to other treatments. It's a two-part study: first finding the right dose and then seeing how well it works more broadly.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever and fatigue, issues from infused cells like allergic reactions or infusion-related symptoms, and possible organ inflammation due to the treatment's targeted action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia (B-ALL) is resistant to standard treatments and tests positive for CD19.
Select...
I am mostly able to care for myself and carry out daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Finding of CAR19-tTregs
Measure CAR19-tTregs efficacy
Secondary outcome measures
Incidence of CR
Incidence of grade 3-4 cytokine release syndrome (CRS)
Incidence of immune cell associated neurotoxicity syndrome (ICANS)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase I/IIExperimental Treatment3 Interventions
Determine the maximum tolerated dose (MTD) of CAR19-tTreg. It will be administered in a single dose after high dose lymphodepleting chemotherapy to promote adoptive transfer. First dose of 1.0 x 10 6 CAR19-tTreg/kg recipient body weight (dose level 1).The subsequent doses are 3.0, 10.0 and 30.0 x 10 6 CAR19- tTreg/kg. PHASE II Expand trial on maximum tolerated dose (MTD) of CAR19-tTreg from Phase I. It will be administered in a single dose after high dose lymphodepleting chemotherapy to promote adoptive transfer.The CAR19-tTreg/kg dose is to be determined.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1080
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
275 Previous Clinical Trials
14,779 Total Patients Enrolled
44 Trials studying Lymphoma
3,208 Patients Enrolled for Lymphoma
Bachanova Veronika, MDPrincipal InvestigatorMasonic Cancer Center, Univeristy of Minnesota

Media Library

CAR19 regulatory T cells (CAR19-tTreg) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05114837 — Phase 1 & 2
Lymphoma Research Study Groups: Phase I/II
Lymphoma Clinical Trial 2023: CAR19 regulatory T cells (CAR19-tTreg) Highlights & Side Effects. Trial Name: NCT05114837 — Phase 1 & 2
CAR19 regulatory T cells (CAR19-tTreg) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05114837 — Phase 1 & 2
~21 spots leftby Aug 2028
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