NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large… (NCT05359211) | Clinical Trial Compass
Active — Not RecruitingPhase 1
NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma
United States27 participantsStarted 2022-12-08
Plain-language summary
This phase Ib trial studies the effects of NKTR-255 in combination with chimeric antigen (CAR)-T cell therapy and to see how well they work in treating patients with large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). 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. Lisocabtagene maraleucel is a CAR-T cell product that 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 together with lisocabtagene maraleucel may work better in treating large B-cell lymphoma than either drug alone.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female \>= 18 years of age at the time of consent
* Patients with LBCL (including diffuse large B-cell lymphoma \[DLBCL\] not otherwise specified \[including DLBCL arising from indolent lymphoma\], high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B) with a Food and Drug Administration (FDA)-approved indication for treatment with liso-cel
* Fludeoxyglucose F-18 (FDG)-avid disease on positron emission tomography (PET) imaging or pathology evidence of active disease
* Evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology
* Karnofsky performance status \>= 60%
* Absolute neutrophil count (ANC) \>= 1000 cells/mm\^3 in the absence of bone marrow involvement by lymphoma
* Platelets \>= 50,000 cells/mm\^3 in the absence of bone marrow involvement by lymphoma
* Hemoglobin \>= 8 g/dL in the absence of bone marrow involvement by lymphoma
* Calculated creatinine clearance (Cockcroft/Gault) \> 30 mL/min/1.73 m\^2
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (or \< 5 x ULN for subjects with lymphomatous infiltration of the liver)
* Total bilirubin =\< 2 (or \< 3.0 for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver)
* Common Terminology Criteria for Adverse Events (CTCAE) Grade =\< 1 dyspnea
* Saturation of oxygen (Sa02) \>= 92% on room air
* Patients with clinicall…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs)
Timeframe: 30 days after the last dose of NKTR-255 or until a new antitumor therapy has been initiated
2
Dose-limiting toxicity (DLT) rates
Timeframe: Up to 21 days after the first NKTR-255 infusion
3
Optimal biological dose (OBD)
Timeframe: Up to 12 months after the CAR-T cell infusion
4
Complete response (CR) rate
Timeframe: Up to 3 months after the CAR-T cell infusion