Clinical trial · Interventional

Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma

A Single-arm, Prospective, Single-center, Phase II Clinical Study of Penpulimab Combined With RMA in the Treatment of Newly Diagnosed Primary CNS Lymphoma

NCT05347641CI-TRIAL-00058035not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

To explore PFS, ORR (CR/CRu+PR), OS and side effects of piamprizumab combined with RMA in newly diagnosed PCNSL, so as to clarify the value of piamprizumab combined with RMA in the first-line treatment of PCNSL patients, and to clarify the clinical and biological factors affecting the efficacy

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Primary Central Nervous System Lymphoma	Primary Central Nervous System Lymphoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Penpulimab	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Penpulimab combined with RMA was used for first-line treatment of PCNSL
description
One course of treatment was performed every 21 days. After 3 courses, patients underwent cranial MR+ whole-body enhanced CT for disease assessment. Patients who did not achieve partial response (PR) were withdrawn, and patients who achieved PR or complete response (CR)/uncertain CR (CRu) were given 3 courses of treatment.
interventionNames
1. Drug: Penpulimab

Primary outcomes (1)

measure
2-year PFS rate of PCNSL patients treated with penpulimab combined with RMA
timeFrame
2 years

Secondary outcomes (1)

measure
ORR, 2-year OS rate and safety of penpurlimab combined with RMA in first-line treatment of PCNSL patients
timeFrame
2 years

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

* For initial PCNSL confirmed by pathological tissue, the diagnostic criteria were based on WHO diagnostic criteria in 2016
* Head MR (plain scan + enhancement) performed 28 days prior to study enrollment should show the presence of at least one measurable lesion in two vertical directions (according to 2014 Lugano criteria); Or abnormal cerebrospinal fluid examination (including cerebrospinal fluid protein, cells, NGS), or ophthalmologic examination confirmed the retina, vitreous lesions
* PS score was 0\~4 according to ECOG

Exclusion Criteria:

* Organs or lymph nodes outside the central nervous system are involved
* Patients with a second primary tumor (other than non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer or breast cancer that has been cured and has not recurred within 5 years)
* Has a history of allergic disease, severe drug allergy, or is known to be allergic to any component of a macromolecular protein preparation or penpulimab injection prescription
* Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR T cell therapy (or any other antibody that acts on T cell co-stimulation or checkpoint pathways)
* A severe acute or chronic infection requiring systemic treatment
* The investigator believes that the subjects may have other factors that affect the efficacy or safety evaluation of the study

References

Publications (1)

DERIVEDShen HR, Wu JZ, Yin H, Du KX, Sibusiso L, Wu YF, Hua W, Li Y, Kong YL, Zhang XY, Gao R, Li JY, Wang L, Liang JH, Xu W. Penpulimab combined with rituximab, high-dose methotrexate, and cytarabine (Pen-RMA) in newly diagnosed primary central nervous system lymphoma (PCNSL): a phase 2 trial. Blood Cancer J. 2026 Feb 11;16(1):23. doi: 10.1038/s41408-026-01450-w. PMID 41672977