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Immune System Booster for Non-Hodgkin's Lymphoma
Phase 2 & 3
Recruiting
Research Sponsored by Nektar Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will test if an immune system booster (NKTR-255) can help fight cancer after using a modified T-cell therapy (CD19 CAR-T) to treat relapsed/refractory large B-cell lymphoma.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for NKTR-255 aren't listed here, similar immune system boosters can cause flu-like symptoms (fever/chills), fatigue, injection site reactions and may affect blood counts or organ function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response (CR) rate at month 6
Event-free survival (EFS)
Secondary outcome measures
Best overall Complete response (CR) rate
Best overall objective response rate (ORR)
Complete response (CR) rate at month 3
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage 1 NKTR-255 at 3.0/6.0 μg/kgExperimental Treatment1 Intervention
In this arm of Stage 1 (Phase 2 of the study), patients will be dosed with 3.0 μg/kg NKTR-255 in Cycle 1 (C1) and continue in Cycle 2 and subsequent cycles (C+) with 6.0 μg/kg NKTR-255 (hereinafter referred to as 3.0/6.0 µg/kg NKTR-255).
NKTR-255 will be administered intravenously approximately 14 days after CD19-directed CAR-T cell infusion.
Patients will be dosed every 3 weeks for up to 7 cycles or 5 months, whichever is earlier, in the absence of disease progression or unacceptable toxicity.
The dose regimen for Stage 2 (Phase 3 of the study) will be selected based on the results of Stage 1 as reviewed by the Data Monitoring Committee (DMC) and the study team.
Group II: Stage 1 NKTR-255 at 3.0 μg/kgExperimental Treatment1 Intervention
In this arm of Stage 1 (Phase 2 of the study), NKTR-255 will be dosed at 3.0 μg/kg. NKTR-255 will be administered intravenously approximately 14 days after CD19-directed CAR-T cell infusion.
Patients will be dosed every 3 weeks for up to 7 cycles or 5 months, whichever is earlier, in the absence of disease progression or unacceptable toxicity.
The dose regimen for Stage 2 (Phase 3 of the study) will be selected based on the results of Stage 1 as reviewed by the Data Monitoring Committee (DMC) and the study team.
Group III: Stage 1 NKTR-255 at 1.5 µg/kgExperimental Treatment1 Intervention
In this arm of Stage 1 (Phase 2 of the study), NKTR-255 will be dosed at 1.5 µg/kg. NKTR-255 will be administered intravenously approximately 14 days after CD19-directed CAR-T cell infusion.
Patients will be dosed every 3 weeks for up to 7 cycles or 5 months, whichever is earlier, in the absence of disease progression or unacceptable toxicity.
The dose regimen for Stage 2 (Phase 3 of the study) will be selected based on the results of Stage 1 as reviewed by the Data Monitoring Committee (DMC) and the study team.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo is commercially available 0.9% Sodium Chloride Solution for Injection (USP). Placebo will be administered intravenously approximately 14 days after CD19-directed CAR-T cell infusion. Placebo will be infused every 3 weeks for up to 7 cycles or 5 months, whichever is earlier.
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Who is running the clinical trial?
Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
9,942 Total Patients Enrolled
Study DirectorStudy DirectorNektar Therapeutics
1,228 Previous Clinical Trials
500,688 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.It's been over 2 weeks since my last cancer treatment.I have had a solid organ transplant.I am very active or have minor symptoms that don't limit my daily activities.I have not had serious heart problems in the last 6 months.I have a significant brain or spinal cord condition.I have an active hepatitis B, hepatitis C, or HIV infection.I have been treated with IL-2 or IL-15 drugs before.I am 18 years old or older.I have received specific chemotherapy to prepare for CAR-T cell therapy.I agree to use effective birth control if my partner can get pregnant.I am willing and able to follow the study's schedule and procedures, including getting a tumor biopsy if possible.It has been over 3 months since my last immune therapy.I am experiencing complications from a stem cell transplant.I have not received any live vaccines in the last 30 days.My cancer did not respond to initial treatment and I can't have a stem cell transplant due to other health issues or age.I have not had CD19 CAR-T cell therapy before, except as allowed in this trial.I have no health issues that would stop me from following the study's requirements.I have not taken high doses of steroids or other immune-weakening drugs recently.I have received standard treatments like axi-cel or liso-cel (for both stages) or tisa-cel (for stage 2 only) as per FDA approval.I haven't had autoimmune or inflammatory disorders in the last year.I have an infection that isn't controlled or needs IV drugs to manage.I have had brain cancer or cancer cells in my brain fluid.My recent PET scan shows active cancer.My condition did not improve after at least two different treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1 NKTR-255 at 3.0 μg/kg
- Group 2: Stage 1 NKTR-255 at 1.5 µg/kg
- Group 3: Stage 1 NKTR-255 at 3.0/6.0 μg/kg
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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