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

Phase 1

Recruiting

• Conditions: Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; DLBCL - Diffuse Large B Cell Lymphoma; DLBCL Arising From Follicular Lymphoma; DLBCL, Diffused Large B Cell Lymphoma; DLBCL NOS; High-grade B-cell Lymphoma; Primary Mediastinal Large B-cell Lymphoma (PMBCL); DLBCL; Transformed Follicular Lymphoma (tFL); Follicular Lymphoma Grade 3B
• Interventions: Biological: P-CD19CD20-ALLO1; Drug: Rimiducid

• Registration Number: NCT06014762
• Lead Sponsor: Poseida Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-28
• Study Start: 2024-04-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2029-03
• Study Completion: 2041-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
P-CD19CD20-ALLO1 CAR-T Cells (Arm S)	P-CD19CD20-ALLO1	P-CD19CD20-ALLO1 following conditioning chemotherapy regimen S. Rimiducid may be administered.
P-CD19CD20-ALLO1 CAR-T Cells (Arm S)	Rimiducid	P-CD19CD20-ALLO1 following conditioning chemotherapy regimen S. Rimiducid may be administered.
P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 750)	Rimiducid	P-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 750. Rimiducid may be administered.
P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 1000)	Rimiducid	P-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 1000. Rimiducid may be administered.
P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 1000)	P-CD19CD20-ALLO1	P-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 1000. Rimiducid may be administered.
P-CD19CD20-ALLO1 CAR-T Cells (Arm LD 750)	P-CD19CD20-ALLO1	P-CD19CD20-ALLO1 following conditioning chemotherapy regimen LD 750. Rimiducid may be administered.

Primary Outcome Measures

Name	Time	Method
Assess the safety and MTD or RDE of P-CD19CD20-ALLO1 based on dose limiting toxicities (DLT)	Baseline through 28 days	Rate of DLT's

Secondary Outcome Measures

Name	Time	Method
The safety of P-CD19CD20-ALLO1 (AEs)	Baseline through 36 months	Incidence and severity of adverse events (AEs)
The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (DOR)	Baseline through 15 years	Duration of Response - Time from complete response (CR) or partial response (PR) to progressive disease
The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (PFS)	Baseline through 15 years	Progression Free Survival (PFS) - Time from P-CD19CD20-ALLO1 treatment to progressive disease
The effect of cell dose and LD regimen to guide selection of specific cell dose and LD regimen for further assessment in Phase 2/3 studies	Baseline through 36 months	Cytokine release syndrome (CRS) graded using American Society for Transplantation and Cellular Therapy (ASTCT) criteria
The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (ORR)	Baseline through 15 years	Overall Response Rate (ORR) - Percentage of patients with complete response (CR) or partial response (PR)
The anti-B cell malignancy effect of P-CD19CD20-ALLO1 (OS)	Baseline through 15 years	Overall Survival (OS) - Duration of survival from time of treatment with P-CD19CD20-ALLO1

Trial Locations

Locations (10)

Our Lady of the Lake Hospital; 🇺🇸 Baton Rouge, Louisiana, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

Loma Linda University Cancer Center; 🇺🇸 Loma Linda, California, United States

Wayne State - Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

UNC Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

University of Oklahoma, Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Prisma Health - Upstate Cancer Institute; 🇺🇸 Greenville, South Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States