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Diffuse Large B Cell LymphomaPhase 1/2NCT05326243

Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma

A Phase 1/2 study testing CD19-targeted chimeric antigen receptor T-cell in people with Diffuse Large B Cell Lymphoma and Primary Mediastinal Large B Cell Lymphoma, run by Pell Bio-Med Technology Co., Ltd. at 5 sites in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 14 years and older
What is being tested?
CD19-targeted chimeric antigen receptor T-cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
5 sitesTaiwan
Study dates
31 May 2022to 31 Mar 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Screening 1:
  • Patient is ≥14 years of age, inclusive, at the time of signing the informed consent.
  • Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMLBCL), large B-cell lymphoma transformed from follicular lymphoma (FL), or grade 3a or 3b FL.
  • On-site documentation of CD19 on the dominant population of cancer cells.
  • Disease status should meet any one of the below:
  • Patients with previous autologous-hematopoietic stem cell transplantation (auto HSCT) have relapsed, progressive, or refractory disease (defined as having not achieved a CR) after transplantation regardless of lines of systemic therapy.
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  • Patients without previous HSCT have relapsed, progressive, or refractory disease (defined as having not achieved a CR) after at least 2 lines of systemic therapy, including anti-CD20 antibody and anthracycline.
  • Have no available effective systemic therapy as judged by the Investigator.
  • At least one measurable non-CNS (central nervous system) lesion based on Lugano classification for lymphoma.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Life expectancy of at least 3 months.
  • Patient is male or female.
  • A male patient must agree to use a highly effective contraception as detailed in Section 10.4 (Appendix 4) during the treatment period and for at least 2 years after the dose of PL001 and refrain from donating sperm during this period.
  • Female Patients:
  • A female patient is eligible to participate if she is not pregnant (Section 10.4; Appendix 4), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Section 10.4 (Appendix 4).
  • OR
  • A WOCBP who agrees to follow the contraceptive guidance in Section 10.4 (Appendix 4) during the treatment period and for at least 2 years after the dose of PL001 and refrain from donating ova during this period.
  • Patient/patient's parent/legal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Screening 2:
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • CAR-T is successfully manufactured and ready for use, from cells harvested by non mobilized leukapheresis.
  • WOCBP who have a negative serum pregnancy test at Screening 2.

Who cannot join

  • Screening 1:
  • Chronic lymphocytic leukemia with Richter's transformation.
  • Primary CNS lymphoma. (Non-primary CNS lymphoma with CNS involvement is eligible).
  • Primary intra-ocular lymphoma.
  • Prior CD19 targeted therapy, such as CAR-T, Bi-specific T-cell engagers (BiTE), or monoclonal antibody.
  • History of cancers (includes myelodysplastic syndrome) other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free without active treatment for at least 3 years.
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  • History of allogeneic HSCT.
  • History of autologous HSCT within 3 months prior to consent.
  • Received any investigational product within 4 weeks prior to consent.
  • Systemic anticancer therapy within 3 weeks prior to apheresis.
  • Long-term use of systemic corticosteroids, defined as daily use >10 mg of prednisolone or equivalent, within 2 weeks prior to leukapheresis.
  • Exception examples:
  • Nasal, ophthalmic, inhaled, intra-articular, and topical steroid preparation.
  • Short term systemic steroid for drug, contrast, or blood transfusion allergic reaction management.
  • Low dose maintenance steroid therapy for other conditions (e.g., asthma).
  • Use of long-acting and short-acting myeloid growth factor within 2 weeks, 5 days prior to leukapheresis, respectively.
  • Received anti-thymocyte globulin within 4 weeks prior to consent.
  • Intrathecal chemotherapy within 1 week prior to leukapheresis.
  • Inadequate major organ functions at Screening, which were defined as any of below:
  • absolute neutrophil count (ANC) <500/µL
  • Absolute lymphocyte count (ALC) <300/µL, excluding leukemic cells.
  • Hemoglobin (Hb) <8.0 g/dL
  • Platelet count <75,000/µL without transfusion support within 3 days
  • e. Baseline O2 saturation <92% by pulse oximetry at room air
  • Significant CNS diseases such as dementia, major stroke, seizure while under antiepileptic drug
  • Aspartate aminotransferase (AST) >5 × upper limit of normal (ULN) and alanine aminotransferase (ALT) >5 × ULN, or total bilirubin >2 × ULN (except for constitutional jaundice)
  • Serum creatinine > 1.5 × ULN and estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m², as calculated by the Cockcroft-Gault formula.
  • Significant cardiac disease including but not limited to: left ventricular ejection fraction (LVEF) <50%, QTc(the corrected QT interval) > 480 msec based on Fredericia's formula, clinically significant arrhythmias, history of myocardial infarction or unstable angina within 3 months prior to consent.
  • Active hepatitis B virus (HBV) infection defined as detectable HBV DNA (Patients with positive anti-hepatitis B core antibody [HBcAb] must consent to regular monitoring of HBV DNA, and anti-HBV prophylaxis with oral anti-viral agent (such as entecavir) is mandatory until End-of-Study visit [Visit 15].)
  • Active hepatitis C virus (HCV) infection defined as positive anti- HCV antibody plus detectable HCV RNA.
  • Positive for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) infection.
  • Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g., the need for intravenous therapeutic antibiotics, blood culture positive ≤72 hours prior to apheresis).
  • 21. Any medical conditions which might compromise the patient's safety from leukapheresis, lymphodepletion chemotherapy, or CAR-T therapy and anticipated AEs, according to the Investigator's evaluation.
  • 22.Patients with insufficient leukapheresis cells.
  • Screening 2:
  • Inadequate major organ functions at Screening which were defined as any of below:
  • ANC <500/µL
  • Hb <8.0 g/dL
  • Platelet count <50,000/µL, without transfusion support within 3 days
  • Baseline O2 saturation <92% by pulse oximetry on room air
  • AST >5 × ULN and ALT>5 × ULN, or total bilirubin >2 × ULN (except for constitutional jaundice)
  • Significant CNS diseases such as dementia, major stroke, seizure while under antiepileptic drug
  • Serum creatinine > 1.5 × ULN and estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m², as calculated by the Cockcroft-Gault formula.
  • Long-term use of systemic corticosteroids, defined as daily use >10 mg of prednisolone or equivalent.
  • Exception examples:
  • Nasal, ophthalmic, inhaled, intra-articular, and topical steroid preparation.
  • Short term systemic steroid for drug, contrast, or blood transfusion allergic reaction management.
  • Low dose maintenance steroid therapy for other conditions (e.g., asthma).
  • Use of long-acting and short-acting myeloid growth factor within 12 days, 2 days prior to lymphodepletion therapy, respectively.
  • Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g. the need for intravenous therapeutic antibiotics, blood culture positive ≤72 hours prior to lymphodepletion).
  • Any medical condition which might compromise the patient's safety because of lymphodepletion chemotherapy or CAR-T therapy and anticipated AEs, according to the Investigator's opinion.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377

  • Chi Mei Medical Center

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, Taiwan, 100225

  • Taipei Medical University - Taipei Medical University Hospital

    Taipei, 11031

  • Taipei Veterans General Hospital

    Taipei, 112201

Other trials in Taiwan

About this study

Official title: A Phase 1/2 Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of CD19-targeted Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) Therapy in Patients With Relapsed or Refractory B-cell Lymphoma

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).

Read the detailed 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.

Being tested
CD19-targeted chimeric antigen receptor T-cell
Keywords
DLBCL, PMLBCL, FL
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD19-targeted chimeric antigen receptor T-cellBiological

    Also called PL001

    Drug: Fludarabine

    patients will receive a lymphodepletion chemotherapy with Fludarabine 25 mg/m2/day IV for 3 days on Day-5 to Day-3(a safe window for a small subset of patients will be D -7 to D -3).

    Drug: Cyclophosphamide

    patients will receive a lymphodepletion chemotherapy with cyclophosphamide 300 mg/m2/day IV for 3 dys Day-5 to Day-3(a safe window for a small subset of patients will be D -7 to D -3).

    Biological: CD19 CAR-T

    CD19 CAR-T cells will be administered using as a single dose at 0.1-9*10^6 cells/kg on Day 0 after completion of the lymphodepletion chemotherapy. The body weight calculated for PL001 dose is the actual body weight on the day of leukapheresis.

Study groups in NCT05326243
Study groupRoleWhat they receive
CD19-targeted chimeric antigen receptor T-cellExperimentalPatients will receive a lymphodepletion chemotherapy with fludarabine plus cyclophosphamide for three consecutive days(Day -5 to Day -3) before infusion of CD19-targeted chimeric antigen receptor T-cell (CD19 CAR-T). Patients will receive the CD19 CAR-T(also known as PL001) infusion on Day 0.
Receives: Biological: CD19-targeted chimeric antigen receptor T-cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Dose-limiting toxicities

    Dose-limiting toxicities through 30 days after PL001 infusion

    Measured: 30 days

  2. Phase 2: best overall response (BOR)

    The best overall response (BOR) comprising patients with partial and complete responses according to Lugano criteria assessed based on the image review result provided by the Independent Central Review from the start of infusion of PL001 until next subsequent cancer-specific therapy, disease progression, death, or end of study, whichever comes first

    Measured: 12 months

Secondary outcomes (6)

  1. Phase 1 and Phase 2: Treatment-related adverse events

    Treatment-related adverse events assessed by CTCAE v 5.0. Overall grading of Cytokine Release Syndrome, immune effector cell associated neurotoxicity syndrome, based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

    Measured: 12 months

  2. Phase 1 and Phase 2: Best overall response (BOR)

    The BOR of patients with partial and complete responses according to Lugano criteria assessed by the Investigator.

    Measured: 12 months

  3. Phase 1 and Phase 2: Median duration of response (mDOR)

    Median duration of response (mDOR) measured from the time of initial documented response (complete response or partial response) until documented disease progression or death.

    Measured: 12 months

  4. Phase 1 and Phase 2: Progression-free survival (PFS)

    Progression-free survival (PFS) defined as the time from the infusion of PL001 until objective disease progression or death, whichever occurs first.

    Measured: 12 months

  5. Phase 1 and Phase 2: Overall survival (OS)

    Overall survival (OS) defined as the time from the infusion of PL001 until death from any cause.

    Measured: 12 months

  6. Phase 1 and Phase 2: the health-related quality of life (HRQoL)

    Change in the health-related quality of life (HRQoL) by FACT-Lym (the Functional Assessment of Cancer Therapy-Lymphoma)® version 4

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2022
  2. Study start31 May 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a multiple-center, non-randomized, open-label, phase 1/2 study. Lymphodepletion chemotherapy (intravenous infusion of fludarabine plus cyclophosphamide will be administered for 3 consecutive days before the day of PL001 dosing (Day 0) and should take place within Day -5 to Day -3 (a safe window for a small subset of patients will be D -7 to D -3). This study will test two dose levels of PL001, dose level 1 and dose level 2. In Phase 1, doses will be tested in the modified "3 + 3" design initiating with dose level 1. The primary objective of Phase 1 is to assess the safety of PL001 and find the recommended phase 2 dose. Phase 2 expansion cohort will receive PL001 at the recommended dose determined in Phase 1. Efficacy evaluations using computed tomography (CT) and positron emission tomography (PET) will be performed at 1, 3, 6, 9, and 12 months.
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05326243
Sponsor's protocol ID
PL001-NHL-201
Status last verified
Oct 2026
First submitted
25 Mar 2022
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD19-targeted chimeric antigen receptor T-cell in people with Diffuse Large B Cell Lymphoma and Primary Mediastinal Large B Cell Lymphoma, run by Pell Bio-Med Technology Co., Ltd. at 5 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Dose-limiting toxicities (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05326243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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