NCT05326243

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
11mo left

Started May 2022

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
May 2022Mar 2027

First Submitted

Initial submission to the registry

March 25, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

4.6 years

First QC Date

March 25, 2022

Last Update Submit

May 7, 2025

Conditions

Diffuse Large B Cell LymphomaPrimary Mediastinal Large B Cell LymphomaLarge B-cell LymphomaFollicular Lymphoma Grade 3AFollicular Lymphoma Grade 3B

Keywords

DLBCLPMLBCLFL

Outcome Measures

Primary Outcomes (2)

  • Phase 1: Dose-limiting toxicities

    Dose-limiting toxicities through 30 days after PL001 infusion

    30 days

  • 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

    12 months

Secondary Outcomes (6)

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

    12 months

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

    12 months

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

    12 months

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

    12 months

  • Phase 1 and Phase 2: Overall survival (OS)

    12 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • Phase 1 and Phase 2: Pharmacokinetic (PK) profile of PL001-Persistence of PL001 by flow cytometry

    12 months

  • Phase 1 and Phase 2: Pharmacokinetic (PK) profile of PL001-Persistence of PL001 by qPCR

    12 months

  • Phase 1 and Phase 2: Quality assurance of the product

    [From start of CAR-T manufacturing to CAR-T infusion, estimated to be 45 days]

  • +1 more other outcomes

Study Arms (1)

CD19-targeted chimeric antigen receptor T-cell

EXPERIMENTAL

Patients 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.

Biological: CD19-targeted chimeric antigen receptor T-cell

Interventions

CD19-targeted chimeric antigen receptor T-cellBIOLOGICAL

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.

Also known as: PL001
CD19-targeted chimeric antigen receptor T-cell

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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:
  • +7 more criteria

You may not qualify if:

  • 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.
  • 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).
  • +36 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

National Taiwan University Hospital

Taipei, Taiwan, 100225, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807377, Taiwan

RECRUITING

Chi Mei Medical Center

Tainan, 710, Taiwan

NOT YET RECRUITING

Taipei Medical University - Taipei Medical University Hospital

Taipei, 11031, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112201, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Chen-Lung Lin, MD

    Pell Bio-Med Technology Co., Ltd.

    STUDY CHAIR

Central Study Contacts

Cherry Lo, MSC

CONTACT

886-2-8791-1789cherry.lo@pellbmt.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 13, 2022

Study Start

May 31, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(5)