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

Recruiting now · Phase 1/Phase 2

Conditions studied: Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Large B-cell Lymphoma, Follicular Lymphoma Grade 3A, Follicular Lymphoma Grade 3B

In brief

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).

Key facts

Study ID: NCT05326243
Run by: Pell Bio-Med Technology Co., Ltd.
People needed: 49
Starts: 2022-05-31
Expected to finish: 2027-03-31
Last updated by the study team: 2025-05-13

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

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:
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.

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).
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

Where it is running

National Taiwan University Hospital — Taipei, Taiwan, Taiwan (enrolling)
Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (enrolling)
Taipei Medical University - Taipei Medical University Hospital — Taipei, Taiwan (enrolling)
Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)
Chi Mei Medical Center — Tainan, Taiwan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.