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CAR T-cell Therapy

Genetically Modified T-cells for Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

Led By Elizabeth Budde

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

Scheduled to receive a standard chemotherapy-based conditioning regimen

Has undergone an autologous HPC(A) procedure

Must not have

Presence of other malignancy or history of prior malignancy within 5 years of study entry

Uncontrolled illness including ongoing or active infection, known active hepatitis B or C infection, or human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well giving a T-cell infusion works in treating patients with non-Hodgkin lymphoma.

Who is the study for?

This trial is for patients with recurrent or high-risk non-Hodgkin lymphoma who are scheduled for a stem cell transplant and have certain levels of healthy stem cells available. They must be able to understand the study, agree to use contraception, and not have uncontrolled infections or other cancers. People can't join if they've had allergic reactions to similar drugs, active hepatitis B/C or HIV, brain metastases, previous transplants, steroid dependence, or active autoimmune diseases.

What is being tested?

The trial is testing genetically modified T-cells after a patient receives a stem cell transplant. The goal is to see how well these modified T-cells work in treating lymphoma by boosting the immune system's ability to fight cancer without causing harm to normal cells.

What are the potential side effects?

Potential side effects may include an immune response against normal cells leading to symptoms like fever and fatigue; complications from chemotherapy such as nausea; risks associated with stem cell transplantation including infection risk; and specific reactions related to the genetic modification of T-cells.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for standard chemotherapy before my main treatment.

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I have had a stem cell transplant using my own cells.

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

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

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My biopsy was reviewed and confirmed to be a type of B-cell NHL like DLBCL.

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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, and I don't need dialysis. My liver is also functioning well.

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I am mostly independent and expected to live more than 16 weeks.

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I am a candidate for a stem cell transplant using my own cells.

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I agree to use birth control during and for six months after the study.

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I meet all requirements for a stem cell transplant using my own cells.

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I have a frozen T cell product ready for use.

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I have a stored stem cell product with enough cells for treatment.

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My condition has not worsened after last-resort treatment.

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I do not have significant brain function issues or new specific symptoms.

Exclusion Criteria

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

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I have not had any other cancer within the last 5 years.

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I do not have any uncontrolled illnesses or active infections, including hepatitis B or C, or HIV.

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I am not currently on any experimental treatments or other cancer therapies.

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

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My cancer has spread to my brain.

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I don't have any conditions that would prevent me from undergoing a stem cell transplant.

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I rely on corticosteroids for my health condition.

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I have had a stem cell transplant from a donor or myself.

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

Adverse events attributed to Tcm adoptive transfer as reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

MTD of CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells based on dose limiting toxicities

Secondary study objectives

CD19+ B cell precursors in the peripheral blood as a surrogate for the in vivo effector function of transferred CD19-specific T cells

Engraftment of the transferred T cell products

Side effects data

From 2023 Phase 3 trial • 416 Patients • NCT00085202

64%

Febrile neutropenia

20%

Vomiting

20%

Infection, blood

14%

Allergic reaction/hypersensitivity (including drug fever)

12%

Pain, abdomen NOS

10%

Nausea

Diarrhea

Infection - other

Colitis, infectious (e.g., Clostridium difficile)

Infection with normal ANC or Grade 1 or 2 neutrophils, blood

Hypotension

Hypertension

Infection with normal ANC or Grade 1 or 2 neutrophils, catheter-related

Anorexia

Infection with unknown ANC, blood

Infection, catheter-related

Hemorrhage, pulmonary/upper respiratory, nose

Pain, head/headache

Hearing: patients with/without baseline audiogram and enrolled in a monitoring program

Seizure

Infection with unknown ANC, meninges (meningitis)

Pleural effusion (non-malignant)

100%

80%

60%

40%

20%

Study treatment Arm

Average-Risk Group

High-Risk Group

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: Treatment (genetically modified T cell infusion)Experimental Treatment3 Interventions

Patients undergo mobilization for autologous stem cell collection with cytoreductive chemotherapy and filgrastim and/or plerixafor per current standard operating policies. Patients undergo myeloablative conditioning regimen per institutional standards beginning day -7 followed by hematopoietic stem cell transplantation on day 0. Patients receive CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells IV on day 2 or 3 (may be delayed up to day 45 if the patient is not yet eligible). Patients who experience disease progression and have not experienced DLTs at greater than or equal to 100 days post HSCT will be allowed to receive an optional second T cell infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

autologous hematopoietic stem cell transplantation

2003

Completed Phase 3

~1990

0 / 23Eligibility criteria met