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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor

271 Previous Clinical Trials

14,594 Total Patients Enrolled

43 Trials studying Lymphoma

3,180 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still enrolling patients for this experiment?

"The clinical trial in question is no longer recruiting patients, as stated on the website. The original posting date was November 1st, 2022 and it was last updated on August 26th, 2022. There are 1461 other trials that are still looking for participants."

Answered by AI

What are the main goals of this clinical trial?

"The purpose of this clinical research, which will take place over 4 weeks and be completed after CAR19-tTregs administrations, is to study the efficacy of CAR19-tTregs. Additionally, we want to track the number of patients that experience ICANS related neurotoxicity, complete response (CR), and relapse out of those that achieved CR."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ph I/II Study of CAR19 Regulatory T Cells (CAR19-tTreg) for R/R CD19+ B-ALL

2024. "Ph I/II Study of CAR19 Regulatory T Cells (CAR19-tTreg) for R/R CD19+ B-ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05114837.