← Back to Search

CAR T-cell Therapy

CAR T-Cell Therapy for Lymphoma and Leukemia

Phase 1

Waitlist Available

Led By Nasheed Hossain, MD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have been diagnosed with histologically confirmed B-ALL that is refractory / recurrent.

Participants must have been diagnosed with histologically confirmed aggressive B cell NHL that is refractory / recurrent.

Must not have

Participants must not have a history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement.

Participants must not have an active bacterial, viral, fungal or other infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new way to produce CAR+ T-cells, which are a type of cell that helps the body fight cancer. The goal is to see if this new method is better than the old one, and if so, to help reduce the side effects of cancer treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include flu-like symptoms, fever, fatigue, headache, muscle pain; low blood cell counts leading to increased infection risk; potential for neurological symptoms like confusion or seizures; allergic reactions during infusion; and organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My B-ALL cancer has not responded to treatment or has come back.

Select...

My aggressive B cell NHL has come back or is not responding to treatment.

Select...

It's been over 30 days since my last CAR therapy, and I don't have high levels of CAR T cells in my blood.

Select...

I do not have an immune system disorder or a history of autoimmune disease that has caused organ damage or needed strong medication in the last 2 years.

Select...

My kidney function is normal or only slightly impaired.

Select...

I don't have heart issues or brain disorders in the past year.

Select...

I am not on blood thinners.

Select...

I am 18 years old or older.

Select...

I am mostly active and can carry out daily activities without significant issues.

Select...

I am capable of becoming pregnant and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't had a heart attack or other major heart issues in the last year.

Select...

I do not have any active infections.

Select...

I do not have HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Successful production of CD19-CD34 CAR product that meet predefined release criteria (cell viability/cell number/transduction efficiency/negative sterility and viral testing) for enrolled patients

Secondary study objectives

Overall survival

Progression free survival

Response to treatment

Other study objectives

Immune response

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Group III: CAR 1.5 x 106 transduced T cells/kg (Dose Level 2)Experimental Treatment3 Interventions

Group IV: CAR 1 x 106 transduced T cells/kg (Dose Level 1)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

FDA approved

Cyclophosphamide

FDA approved

0 / 13Eligibility criteria met