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

Nanjing Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Primary Central Nervous System Lymphoma

Treatments: Drug: Penpulimab

Study type: Interventional

Funder types: Other

Identifiers

NCT05347641

IRB-GL1-AF03

Details and patient eligibility

About

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

Enrollment: 23 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Penpulimab combined with RMA was used for first-line treatment of PCNSL

Experimental group

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.

Treatment:

Drug: Penpulimab