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New treatment option for Diffuse Large B Cell Lymphoma
Official title Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma
ClinicalTrials.gov ID: NCT05326243
What this study is testing
What is CD19-targeted chimeric antigen receptor T-cell?
CD19-targeted chimeric antigen receptor T-cell is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b cell lymphoma.
Also referred to as PL001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join 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...
- On-site documentation of CD19 on the dominant population of cancer cells.
- Disease status should meet any one of the below:
You likely can't join 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)...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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.
What rules you out
- 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
- 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) \ 480 msec based on Fredericia's formula, clinically significant arrhythmias, history of myocardial infarction or...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan, Taiwan
- Kaohsiung City, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan, Taiwan; Kaohsiung City, Taiwan; Tainan, Taiwan; Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.