Actively Recruiting
Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma
Led by Pell Bio-Med Technology Co., Ltd. · Updated on 2025-05-13
49
Participants Needed
5
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 14 years of age or older at the time of signing informed consent
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, large B-cell lymphoma transformed from follicular lymphoma, or grade 3a or 3b follicular lymphoma
- On-site documentation of CD19 on dominant cancer cells
- Disease status includes relapsed, progressive, or refractory disease after autologous stem cell transplant or after at least 2 lines of systemic therapy including anti-CD20 antibody and anthracycline
- No effective systemic therapy available as judged by the Investigator
- At least one measurable non-central nervous system lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months
- Male or female patients
- Male patients agree to use highly effective contraception during treatment and for 2 years after PL001 dosing
- Female patients not pregnant, not breastfeeding, and either not women of childbearing potential or willing to follow contraception guidance during treatment and for 2 years after PL001 dosing
- Patient or legal guardian can provide signed informed consent and comply with study requirements
- CAR-T successfully manufactured from leukapheresis
- Women of childbearing potential have a negative serum pregnancy test at screening
You will not qualify if you...
- Chronic lymphocytic leukemia with Richter's transformation
- Primary central nervous system lymphoma (non-primary CNS lymphoma with CNS involvement allowed)
- Primary intra-ocular lymphoma
- Prior CD19 targeted therapy such as CAR-T, Bi-specific T-cell engagers, or monoclonal antibody
- History of cancers other than non-melanoma skin cancer or carcinoma in situ unless disease-free and off treatment for at least 3 years
- History of allogeneic hematopoietic stem cell transplant
- Autologous hematopoietic stem cell transplant within 3 months prior to consent
- Received investigational product within 4 weeks prior to consent
- Systemic anticancer therapy within 3 weeks prior to leukapheresis
- Long-term systemic corticosteroids (daily use >10 mg prednisolone or equivalent) within 2 weeks prior to leukapheresis, except certain exceptions
- Use of long-acting or short-acting myeloid growth factors within specified times before leukapheresis
- Received anti-thymocyte globulin within 4 weeks prior to consent
- Intrathecal chemotherapy within 1 week prior to leukapheresis
- Inadequate major organ functions as defined by blood counts, oxygen saturation, liver enzymes, kidney function, cardiac function
- Active hepatitis B or C virus infection
- Positive for HIV or HTLV infection
- Uncontrolled acute life-threatening infections requiring intravenous antibiotics or recent blood culture positive
- Medical conditions compromising safety for leukapheresis, chemotherapy, or CAR-T therapy
- Insufficient leukapheresis cells
- Long-term systemic corticosteroids use before lymphodepletion
- Use of myeloid growth factors before lymphodepletion
- Uncontrolled acute infections before lymphodepletion
- Any medical condition compromising safety during lymphodepletion or CAR-T therapy as per Investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
National Taiwan University Hospital
Taipei, Taiwan, Taiwan, 100225
Actively Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807377
Actively Recruiting
3
Chi Mei Medical Center
Tainan, Taiwan, 710
Not Yet Recruiting
4
Taipei Medical University - Taipei Medical University Hospital
Taipei, Taiwan, 11031
Actively Recruiting
5
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Actively Recruiting
Research Team
C
Cherry Lo, MSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here