NCT06014762

P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies

Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects With Selected Relapsed/Refractory B Cell Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Poseida Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 study comprised of open-label, dose escalation and expansion cohort study of P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory B cell malignancies

Detailed description

Phase 1 study consisting of two parts. Part 1 is a weight-based dose escalation following a 3+3 design of dose-escalating cohorts to define a maximum tolerated dose (MTD). Part 2 includes administration at a selected dose and LD regimen. After enrollment, subjects will receive a lymphodepletion therapy regimen before administration of allogeneic CAR-T cells, administered as a single dose. Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered.

Conditions

• Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• High-grade B-cell Lymphoma
• Primary Mediastinal Large B-cell Lymphoma (PMBCL)
• Transformed Follicular Lymphoma (tFL)
• Follicular Lymphoma Grade 3B
• DLBCL
• DLBCL - Diffuse Large B Cell Lymphoma
• DLBCL Arising From Follicular Lymphoma
• DLBCL, Diffused Large B Cell Lymphoma
• DLBCL NOS

Interventions

Type	Name	Description
BIOLOGICAL	P-CD19CD20-ALLO1	Single weight-based IV administration
DRUG	Rimiducid	Single weight-based IV administration

Timeline

• Start date: 2024-04-16
• Primary completion: 2029-03-01
• Completion: 2041-03-01
• First posted: 2023-08-28
• Last updated: 2026-02-27

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study