Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05359211 | NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma | PHASE1 | ACTIVE NOT_RECRUITING | 27 | — | — | Dec 8, 2022 | Sep 4, 2026 | Mar 20, 2026 | 1 | United States |
Grade ≥ 3 AEs considered related to NKTR-255 will be listed and summarized. Summaries of grade ≥ 3 laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the safety evaluable population.
Observed DLT rates will be summarized based on the DLT evaluable population. Final DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm.
A composite of clinical information will be utilized to determine the OBD based on safety and tolerability, confirmation of maximum target engagement, optimal biological effects without undesirable clinical effects, pharmacokinetic parameters, and biological response data.
The CR rate will be summarized along with the 2-sided 95% exact Clopper-Pearson confidence interval based on the efficacy evaluable population.
| Arm | Type | Description |
|---|---|---|
| Treatment (lymphodepletion, liso-cel, NKTR-255) | EXPERIMENTAL | Patients receive standard of care lymphodepletion therapy consisting of cyclophosphamide and fludarabine on days -5 to -3 followed by liso-cel CAR-T cell infusion on day 0. Patients then receive NKTR-255 IV over 30 minutes every 3 weeks starting on day 10 or 14 for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray and ECHO or MUGA during screening. Patients undergo bone marrow biopsy and aspiration, LP for CSF sample collection during screening, on the study and during follow-up as clinically indicated. Patients also undergo PET/CT throughout the trial. Additionally, patients undergo blood sample collection and may optionally undergo tissue biopsy throughout the trial. |
| Name | Type | Description |
|---|---|---|
| Cyclophosphamide | DRUG | Given IV |
| Fludarabine | DRUG | Given IV |
| Lisocabtagene Maraleucel | BIOLOGICAL | Given IV |
| Polymer-conjugated IL-15 Receptor Agonist NKTR-255 | DRUG | Given IV |
| X-Ray Imaging | PROCEDURE | Undergo x-ray imaging |
| Echocardiography | PROCEDURE | Undergo ECHO |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy and aspiration |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow biopsy and aspiration |
| Lumbar Puncture | PROCEDURE | Undergo LP |
| Computed Tomography | PROCEDURE | Undergo PET/CT |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Biospecimen Collection | PROCEDURE | Undergo blood and CSF sample collection |
| Biopsy | PROCEDURE | Undergo tissue biopsy |
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, ...