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CAR T-cell Therapy

CAR T-Cell Therapy + Ipilimumab for Non-Hodgkin's Lymphoma (CRETI-NH Trial)

Phase 1

Waitlist Available

Led By Carlos Ramos, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Recovered from the toxic effects of all prior chemotherapy before entering this study

Available autologous transduced peripheral blood T-cells with greater than/=15% expression of CD19CAR determined by flow-cytometry

Must not have

Tumor in a location where enlargement could cause airway obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that involves genetically modifying immune cells to attack the cancer.

Who is the study for?

This trial is for people with certain types of blood cancers like non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, or Chronic Lymphocytic Leukemia that have returned or persisted despite treatment. Participants need to have a specific type of T-cell in their blood, be recovered from previous treatments, and meet certain health criteria including organ function and blood counts. Pregnant individuals or those with allergies to mouse proteins cannot join.

What is being tested?

The study tests genetically modified T-cells combined with an antibody called anti-CD19 to fight cancer. These special cells are designed to better recognize and kill cancer cells by targeting CD19 on their surface. The trial aims to determine the highest safe dose, understand side effects, how long the T-cells last in the body, and if they're effective against lymphoma or leukemia.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as fever and fatigue; risk of infection; possible allergic reactions due to murine (mouse) protein components; issues from increased immune activity like inflammation in organs; plus typical risks associated with cell transfusions.

Eligibility Criteria

Inclusion Criteria

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

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I have recovered from side effects of my previous cancer treatments.

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My T-cells are modified to fight cancer and show more than 15% CD19CAR expression.

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I can care for myself but may need occasional help.

Exclusion Criteria

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

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My tumor is located where it could block my airway if it grows.

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 Event Data per Patient

Secondary study objectives

Correlation of additional doses and cumulative rise in the percentage of circulating gene modified cells

Number of patients with tumor response

Survival and function of CD19CAR T cells

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: CD19CAR-28-zeta T cellsExperimental Treatment2 Interventions

Three dose levels of CTLs will be evaluated. Each patient will receive one injection according to their assigned dose over 1-10 minutes IV. \*At the discretion of the attending physician, if after a 4 to 6-week evaluation period the patient has had apparent clinical benefit (as determined by symptoms, physical exam or radiological studies); repeat infusions separated by 4 to 6 weeks (up to a maximum of 3 extra doses) of modified T cells at the same dose level or below the patient's original dose can be administered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3420

0 / 4Eligibility criteria met