30 Participants Needed

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

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.

What data supports the effectiveness of the treatment Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells for Non-Hodgkin's Lymphoma?

In a study, patients with B-cell non-Hodgkin lymphoma who received genetically modified T cells after stem cell transplantation showed promising results, with 75% of patients remaining progression-free at 1 year. This suggests that the treatment may help control the disease and prevent relapse.12345

Is the genetically modified T-cell treatment for Non-Hodgkin's Lymphoma safe?

Studies show that genetically modified T-cell treatments, like CD19 CAR T-cell therapy, are generally safe in humans, with some patients experiencing mild side effects such as cytokine release syndrome (a reaction that can cause fever and low blood pressure) and neurotoxicity (nerve-related side effects). However, there is a potential risk of secondary cancers, and long-term follow-up is recommended to monitor for late toxicities.14678

How is the treatment with genetically modified T-cells for Non-Hodgkin's Lymphoma different from other treatments?

This treatment is unique because it uses genetically modified T-cells that are engineered to specifically target cancer cells, offering a personalized approach that works differently from traditional chemotherapy or radiation. It combines cell and gene therapy to enhance the immune system's ability to fight cancer, which is a novel approach compared to standard treatments.1391011

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of genetically modified T-cells following peripheral blood stem cell transplant in treating patients with recurrent or high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect)

Research Team

EB

Elizabeth Budde

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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.

Inclusion Criteria

My biopsy was reviewed and confirmed to be a type of B-cell NHL like DLBCL.
I am scheduled for standard chemotherapy before my main treatment.
I have had a stem cell transplant using my own cells.
See 15 more

Exclusion Criteria

Failure to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I/II study
I do not have any uncontrolled illnesses or active infections, including hepatitis B or C, or HIV.
I am not currently on any experimental treatments or other cancer therapies.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mobilization and Conditioning

Patients undergo mobilization for autologous stem cell collection with cytoreductive chemotherapy and filgrastim and/or plerixafor, followed by a myeloablative conditioning regimen

7 days
In-patient stay

Stem Cell Transplantation

Hematopoietic stem cell transplantation is performed on day 0

1 day
In-patient stay

T-cell Infusion

Patients receive CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells IV on day 2 or 3, which may be delayed up to day 45 if the patient is not yet eligible

1-45 days
In-patient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 15 years
Weekly for 1 month, monthly for 1 year, then yearly

Treatment Details

Interventions

  • Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells
  • Autologous Hematopoietic Stem Cell Transplantation
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

A new Phase I clinical trial at MD Anderson Cancer Center is investigating the safety and feasibility of using autologous T cells modified to express a CD19-specific chimeric antigen receptor (CAR) in patients with high-risk B-lymphoid malignancies undergoing hematopoietic stem-cell transplantation (HSCT).
This approach combines cell and gene therapies, utilizing a nonviral gene transfer method to create tumor-specific T cells, which may enhance treatment efficacy while minimizing the toxicities associated with traditional chemotherapy and radiotherapy.
Infusing CD19-directed T cells to augment disease control in patients undergoing autologous hematopoietic stem-cell transplantation for advanced B-lymphoid malignancies.Kebriaei, P., Huls, H., Jena, B., et al.[2021]
The study reports on three patients with relapsed B-cell lymphomas who were treated with autologous T cells modified to express a CD20-targeted chimeric antigen receptor (CAR), showing promising clinical efficacy.
The treatment demonstrated a favorable safety profile, indicating that genetically modified T cells can be a viable option for patients with relapsed B-cell lymphomas.
CARs and cancers: questions and answers.Brentjens, RJ.[2021]
The FDA is currently investigating potential links between BCMA- and CD19-directed CAR T-cell therapies and the development of secondary cancers in patients, highlighting a safety concern.
Despite these concerns, both the FDA and hematologists emphasize that the life-saving benefits of these immunotherapies for treating blood cancers outweigh the risks associated with secondary malignancies.
FDA Investigating CAR-Related T-cell Malignancies.[2023]

References

Infusing CD19-directed T cells to augment disease control in patients undergoing autologous hematopoietic stem-cell transplantation for advanced B-lymphoid malignancies. [2021]
Fast Cars and No Brakes: Autologous Stem Cell Transplantation as a Platform for Novel Immunotherapies. [2018]
CARs and cancers: questions and answers. [2021]
Phase 1 studies of central memory-derived CD19 CAR T-cell therapy following autologous HSCT in patients with B-cell NHL. [2022]
Reprint of: Fast Cars and No Brakes: Autologous Stem Cell Transplantation as a Platform for Novel Immunotherapies. [2016]
FDA Investigating CAR-Related T-cell Malignancies. [2023]
7.Czech Republicpubmed.ncbi.nlm.nih.gov
Practical aspects of CAR-T cell therapy. [2022]
Preferential expansion of CD8+ CD19-CAR T cells postinfusion and the role of disease burden on outcome in pediatric B-ALL. [2022]
Recent advances in engineered T cell therapies targeting B cell malignancies. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Adoptive immunotherapy for indolent non-Hodgkin lymphoma and mantle cell lymphoma using genetically modified autologous CD20-specific T cells. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Immunotherapy of cancer using systemically delivered gene-modified human T lymphocytes. [2014]
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