Clinical Trials Logo

Clinical Trial Summary

This is a multiple center, non-randomized, open-label, phase 1/2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D). The objective of Phase 2 is to evaluate the safety and efficacy of CD19 CAR-T(known as PL001).


Clinical Trial Description

Cluster of differentiation (CD) 19 chimeric antigen receptor T-cell (CAR-T) has been a very promising treatment option for multiple types of B-cell lymphoma. Kymriah® (tisagenlecleucel, Novartis) and Yescarta® (axicabtagene ciloleucel, Gilead) were licensed by the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) in 2017 to treat relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL), and High-grade B-cell lymphoma (HGBCL). A third anti-CD19 CAR-T product, Tecartus (brexucabtagene autoleucel, Gilead) was approved by the US FDA for relapsed and refractory mantle cell lymphoma (MCL) in July 2020. In February 2021, another product, Breyanzi® (lisocabtagene maraleucel, Juno Therapeutics, Inc.), was approved by the US FDA for relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, Primary mediastinal large B cell lymphoma (PMLBCL), and Gr. 3b FL. Currently, in Taiwan, no CD19 CAR-T therapies are available commercially.This Phase 1/Phase 2 study will test PL001, a CD19 CAR-T therapy manufactured by Pell Bio-Med Technology Co., Ltd., as a monotherapy for relapsed or refractory B-cell lymphoma. The Phase 1 of the study will be conducted to establish a dose range that is well tolerated by the majority of patients and to provide a safety profile of PL001 in the target patient population. The results of the Phase 1 of the study will recommend the dose selection for the Phase 2 of the study. Phase 2 of the study will assess the efficacy and safety of PL001 in patients with relapsed or refractory B cell lymphoma. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05326243
Study type Interventional
Source Pell Bio-Med Technology Co., Ltd.
Contact Cherry Lo, MSC
Phone 886-2-8791-1789
Email cherry.lo@pellbmt.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 31, 2022
Completion date March 31, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04670029 - Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line Phase 3
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Active, not recruiting NCT04572763 - Copanlisib Plus Venetoclax in R/R DLBCL Phase 1/Phase 2
Recruiting NCT03676504 - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR Phase 1/Phase 2
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Completed NCT03287817 - CD19/22 CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma Phase 1/Phase 2
Enrolling by invitation NCT05645744 - Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.
Completed NCT04316624 - A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy Phase 1
Active, not recruiting NCT04555811 - FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL Phase 1
Terminated NCT04189952 - Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma Phase 2
Recruiting NCT01949818 - Treatment of Diffuse Large B Cell Lymphoma Phase 4
Completed NCT01459887 - Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma Phase 3
Completed NCT03242902 - To Decrease Fatigue With Light Therapy Phase 3
Recruiting NCT04104776 - A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas Phase 1/Phase 2
Recruiting NCT05018520 - The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk Phase 3
Withdrawn NCT04052061 - QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma Phase 1
Recruiting NCT05020392 - Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma Phase 3
Recruiting NCT05006716 - A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies Phase 1/Phase 2
Completed NCT03297424 - A Study of PLX2853 in Advanced Malignancies. Phase 1
Recruiting NCT04545762 - Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma Phase 1