15 Participants Needed

Immune System Booster for Non-Hodgkin's Lymphoma

Recruiting at 25 trial locations
NR
Overseen ByNektar Recruitment
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Nektar Therapeutics
Must be taking: CAR-T cell therapy
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the safety and efficacy of NKTR-255 following CD19-directed chimeric antigen (CAR)-T cell therapy in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL).NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. T cells are infection fighting blood cells that can kill tumor cells. Chimeric antigen (CAR)-T cell product consists of genetically engineered T-cells, modified to recognize CD19, a protein on the surface of cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19-positive cancer cells. Giving NKTR-255 following the treatment with CD19 CAR-T cell therapy may work better in treating large B-cell lymphoma than either drug alone.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot use therapeutic doses of corticosteroids or other systemic immunosuppressants within 7 days before leukapheresis or 72 hours before CAR-T cell infusion. Topical and inhaled steroids are allowed. It's best to discuss your specific medications with the trial team.

What safety data exists for the immune system booster treatment for Non-Hodgkin's Lymphoma?

The treatment, potentially known as NKTR-255, has been evaluated in various studies. In a phase 1 trial involving CAR-NKT cells for neuroblastoma, no dose-limiting toxicities were observed, and the treatment was considered safe with no significant adverse events attributed to the CAR-NKT cells. Another study involving NKG2D-CAR T cells in patients with AML/MDS and multiple myeloma reported no dose-limiting toxicities, cytokine release syndrome, or CAR T cell-related neurotoxicity. These findings suggest that similar immune-based treatments have been safely administered in clinical settings, although specific safety data for NKTR-255 in Non-Hodgkin's Lymphoma is not directly mentioned in the provided research.12345

Is the treatment in the trial 'Immune System Booster for Non-Hodgkin's Lymphoma' a promising treatment?

Yes, the treatment is promising because immunotherapy has shown strong activity against aggressive forms of non-Hodgkin's lymphoma, like NK/T-cell lymphoma. It can help the immune system attack cancer cells more effectively, offering hope for better outcomes in patients who have limited options with traditional treatments.678910

What data supports the idea that Immune System Booster for Non-Hodgkin's Lymphoma (also known as: NKTR-255, NKTR-255) is an effective treatment?

The available research shows that treatments using NKT cell-targeted vaccines, which are similar in approach to NKTR-255, have been effective in generating strong immune responses against B cell lymphoma. For example, one study found that combining a vaccine with an antibody treatment led to complete eradication of lymphoma in over 50% of mice, and these mice were resistant to the disease when exposed again later. Another study demonstrated that a single vaccination could significantly slow tumor growth and extend survival in mice. These results suggest that immune system boosters like NKTR-255 could be effective in treating Non-Hodgkin's Lymphoma by enhancing the body's immune response to fight the cancer.1241112

Who Is on the Research Team?

SD

Study Director

Principal Investigator

Nektar Therapeutics

Are You a Good Fit for This Trial?

Adults with relapsed/refractory large B-cell lymphoma who've had standard CAR-T cell therapy and specific chemotherapy. They must not have used certain immune therapies recently, have good organ function, and agree to contraception if of reproductive potential. Excluded are those with prior IL-15 agonist treatment, recent steroids or immunosuppression use, other CD19-directed CAR-T treatments, active infections like hepatitis/HIV, CNS lymphoma history, uncontrolled infections requiring IV drugs.

Inclusion Criteria

My lymphoma tests show CD19 presence or it's likely based on my cancer type.
I agree to use birth control if I can become pregnant.
My organs, including my bone marrow, kidneys, liver, lungs, and heart, are working well.
See 9 more

Exclusion Criteria

Presence of any indwelling line or drain
I have had a solid organ transplant.
Use of investigational agents or devices within specified timeframes
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepletion Chemotherapy

Patients receive lymphodepletion chemotherapy as recommended by the CAR-T cell manufacturer

1 week

CAR-T Cell Infusion

Patients receive a one-time CD19-directed CAR-T cell infusion

1 day

Treatment

Study drug (NKTR-255 or placebo) is administered intravenously every 3 weeks for up to 7 cycles or 5 months

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years
Follow-up at 30 days, and then at 9, 12, 18, 24, and 36 months after CAR-T cell infusion

What Are the Treatments Tested in This Trial?

Interventions

  • NKTR-255
Trial Overview The trial tests NKTR-255's effectiveness in enhancing the body's immune response after CD19-directed CAR-T cell therapy in patients with stubborn large B-cell lymphoma. It compares different doses of NKTR-255 against a placebo to see if it improves cancer-fighting outcomes.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage 1 NKTR-255 at 3.0/6.0 μg/kgExperimental Treatment1 Intervention
Group II: Stage 1 NKTR-255 at 3.0 μg/kgExperimental Treatment1 Intervention
Group III: Stage 1 NKTR-255 at 1.5 µg/kgExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nektar Therapeutics

Lead Sponsor

Trials
59
Recruited
9,900+

Howard W. Robin

Nektar Therapeutics

Chief Executive Officer since 2007

B.S. in Accounting and Finance from Fairleigh Dickinson University

Dr. Dimitry Nuyten

Nektar Therapeutics

Chief Medical Officer since 2022

MD

Published Research Related to This Trial

A therapeutic vaccine using α-galactosylceramide (α-GalCer) loaded onto irradiated tumor cells significantly inhibited tumor growth and prolonged survival in a mouse model of B-cell lymphoma, highlighting its potential efficacy in boosting antitumor immunity.
The vaccine's effectiveness relied on the activation of NKT cells, NK cells, and CD8 T cells, with a notable increase in IFN-γ production, suggesting that targeting NKT cell ligands could be a promising strategy for immunotherapy in hematologic cancers.
NKT cell adjuvant-based tumor vaccine for treatment of myc oncogene-driven mouse B-cell lymphoma.Mattarollo, SR., West, AC., Steegh, K., et al.[2021]
The study developed a therapeutic vaccine using A20 lysate and an NKT cell agonist, α-galactosylceramide, which provided long-term immune protection against aggressive B cell lymphoma in a murine model, primarily through CD8 T cell responses.
Key immune biomarkers, such as the strength of the germinal center reaction and the Th1 type humoral response, were identified as predictors of long-term survival, highlighting the potential for this vaccine to be a simple and effective treatment option for B lymphoma.
A simple, clinically relevant therapeutic vaccine shows long-term protection in an aggressive, delayed-treatment B lymphoma model.Pradhan, P., Leleux, J., Liu, J., et al.[2019]
An autologous lymphoma vaccine that activates NKT cells was shown to generate effective tumor-specific immunity in mice, leading to significant tumor regression and resistance to tumor rechallenge.
The study identified that conventional CD4(+) T cells, rather than CD8(+) T cells, were crucial for mediating this antitumor immunity, suggesting a targeted approach for developing immunotherapies against human lymphomas.
An NKT-mediated autologous vaccine generates CD4 T-cell dependent potent antilymphoma immunity.Chung, Y., Qin, H., Kang, CY., et al.[2022]

Citations

NKT cell adjuvant-based tumor vaccine for treatment of myc oncogene-driven mouse B-cell lymphoma. [2021]
A simple, clinically relevant therapeutic vaccine shows long-term protection in an aggressive, delayed-treatment B lymphoma model. [2019]
An NKT-mediated autologous vaccine generates CD4 T-cell dependent potent antilymphoma immunity. [2022]
Anti-SARS-CoV-2 cellular response after 2 and 3 doses of BNT162b2 mRNA vaccine in lymphoma patients receiving anti-CD20 antibodies. [2023]
NKT cell-targeted vaccination plus anti-4-1BB antibody generates persistent CD8 T cell immunity against B cell lymphoma. [2021]
Anti-GD2 CAR-NKT cells in patients with relapsed or refractory neuroblastoma: an interim analysis. [2023]
Phase I Trial of Autologous CAR T Cells Targeting NKG2D Ligands in Patients with AML/MDS and Multiple Myeloma. [2021]
Advances and challenges of immunotherapies in NK/T cell lymphomas. [2023]
[Advances in immunotherapy of extranodal NK/T cell lymphoma]. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
IL-2Rα up-regulation is mediated by latent membrane protein 1 and promotes lymphomagenesis and chemotherapy resistance in natural killer/T-cell lymphoma. [2020]
Allogeneic hematopoietic stem cell transplantation for NK/T-cell lymphoma: an international collaborative analysis. [2023]
How we treat NK/T-cell lymphomas. [2023]
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