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CAR T-cell Therapy

Cellular Immunotherapy After Chemotherapy for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Phase 1

Waitlist Available

Led By Tanya Siddiqi

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Disease stratum 2 (CLL/PLL/SLL): chronic lymphocytic leukemia (CLL), and B-cell prolymphocytic leukemia (PLL), and small lymphocytic lymphoma (SLL)

Karnofsky performance status (KPS) of >= 70%

Must not have

Research participants with any uncontrolled illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, poorly controlled pulmonary disease or psychiatric illness/social situations that would limit compliance with study requirements

Any known contraindications to cyclophosphamide, fludarabine, etoposide, bendamustine, cetuximab or tocilizumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of cellular immunotherapy following chemotherapy in treating patients with non-Hodgkin lymphomas, chronic lymphocytic leukemia, or B-cell prolymphocytic leukemia that has come back.

Who is the study for?

This trial is for patients with certain types of blood cancers that have returned, including various non-Hodgkin lymphomas and chronic leukemias. Participants should have a life expectancy of at least 16 weeks, be able to use contraception, understand the study and consent to it, have adequate organ function (kidney, liver, heart), not be on immunosuppressants or other disqualifying treatments recently, and not need oxygen or intensive care support.

What is being tested?

The trial tests a cellular immunotherapy where white blood cells are genetically modified to attack cancer following chemotherapy. It aims to determine the best dose and side effects of this treatment in patients whose disease has recurred after previous therapies.

What are the potential side effects?

Potential side effects include reactions related to the immune system's activation such as fever or fatigue; complications from cell infusion; possible damage to organs targeted by the engineered cells; and typical chemotherapy-related issues like nausea or low blood counts.

Eligibility Criteria

Inclusion Criteria

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

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I have CLL, PLL, or SLL.

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I am able to care for myself but may not be able to do active work.

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My last chemotherapy dose was over a week ago.

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My diagnosis of B cell lymphoma has been confirmed to be recurring, worsening, or remaining.

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My diagnosis is a type of B-cell lymphoma.

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My kidney function, measured by creatinine clearance, is good.

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It has been over 2 weeks since my last dose of immunosuppressant medications.

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My platelet count is above 50,000 without needing transfusions or growth support for a week.

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I do not need medication to maintain my blood pressure and do not have heart rhythm problems.

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My kidney function is normal, with creatinine levels not doubled.

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My last strong chemotherapy was over 2 weeks ago.

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I have a frozen T cell product ready for infusion.

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I don't need extra oxygen and my oxygen levels are 90% or higher without help.

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Side effects from my previous treatments have mostly gone away or are permanent.

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I do not have any ongoing infections that aren't under control.

Exclusion Criteria

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

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I do not have any uncontrolled illnesses that would affect my study participation.

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I am not allergic or sensitive to specific cancer drugs like cyclophosphamide or tocilizumab.

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I rely on corticosteroids for my health condition.

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I understand the study's purpose, procedures, and the risks/benefits of participating.

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I am on medication to suppress my immune system due to an autoimmune disease.

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I have precursor B-cell acute lymphoblastic leukemia/lymphoma or plasma cell dyscrasias.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Dose-limiting toxicity rate at the recommended phase II dose assessed using CTCAE v4.0

Toxicity profile of T-cell infusion as defined by all toxicities associated with T cells at the probably or definite levels

Secondary study objectives

CD19 B cell aplasia/immunoglobulin G levels

Detection of transferred T cells in the circulation for at least 28 days by quantitative-polymerase chain reaction

Biopsy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (lymphodepletion, cellular immunotherapy)Experimental Treatment5 Interventions

LYMPHODEPLETING REGIMEN: Patients receive a chemotherapy regimen based on disease type and extent of disease comprising of cyclophosphamide, bendamustine hydrochloride, fludarabine phosphate, etoposide. CELLULAR IMMUNOTHERAPY: Beginning 3-10 days later after lymphodepletion, patients receive autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes IV over 10-15 minutes on day 0. Patients with relapsed, residual or progressive disease may receive an optional second infusion of autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes \>= 28 days post T cell infusion. Disease status: Patients with Chronic lymphocytic leukemia (CLL) and/or Prolymphocytic Leukemia (PLL).

Group II: Group I (lymphodepletion, cellular immunotherapy)Experimental Treatment5 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Etoposide

2010

Completed Phase 3