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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Infection - other

Diarrhea

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

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

Hypotension

Infection with unknown ANC, blood

Anorexia

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

Hypertension

Pain, head/headache

Infection, catheter-related

Hemorrhage, pulmonary/upper respiratory, nose

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

Infection with unknown ANC, meninges (meningitis)

Seizure

Pleural effusion (non-malignant)

100%

80%

60%

40%

20%

Study treatment Arm

Average-Risk Group

High-Risk Group

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 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,430 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,095 Total Patients Enrolled

Elizabeth BuddePrincipal InvestigatorCity of Hope Medical Center

1 Previous Clinical Trials

16 Total Patients Enrolled

Media Library

Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01815749 — Phase 1

Marginal Zone Lymphoma Research Study Groups: Treatment (genetically modified T cell infusion)

Marginal Zone Lymphoma Clinical Trial 2023: Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells Highlights & Side Effects. Trial Name: NCT01815749 — Phase 1

Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01815749 — Phase 1

Frequently Asked Questions

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

Does the FDA approve of autologous hematopoietic stem cell transplantation?

"The safety of autologous hematopoietic stem cell transplantation is rated 1, as Phase 1 trials indicate limited data demonstrating its efficacy and security."

Answered by AI

Are there opportunities for patient participation in this experiment yet?

"This research endeavour, which was initially announced on October 8th 2013 and updated most recently on May 11th 2022, is not currently recruiting. Nevertheless, there are over 3000 clinical trials actively enlisting patients at this moment in time."

Answered by AI

Recent research and studies

BloodJournal

Phase 1 Studies of Central Memory–derived CD19 CAR T–cell Therapy Following Autologous HSCT in Patients with B-cell NHL

Wang, Xiuli, Leslie L. Popplewell, Jamie R. Wagner, Araceli Naranjo, M. Suzette Blanchard, Michelle R. Mott, Adam P. Norris, et al.. 2016. “Phase 1 Studies of Central Memory–derived CD19 CAR T–cell Therapy Following Autologous HSCT in Patients with B-cell NHL”. Blood. American Society of Hematology. doi:10.1182/blood-2015-12-686725.

clinicaltrials.govStudy

Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma

2013. "Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01815749.

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