OncoMatch/Clinical Trials/NCT05326243
Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma
Is NCT05326243 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CD19-targeted chimeric antigen receptor T-cell for diffuse large b cell lymphoma.
Treatment: CD19-targeted chimeric antigen receptor T-cell — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression on dominant population of cancer cells
On-site documentation of CD19 on the dominant population of cancer cells.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: autologous hematopoietic stem cell transplant
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.
Must have received: anti-CD20 antibody
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.
Must have received: anthracycline
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.
Cannot have received: CD19 targeted therapy (CAR-T, Bi-specific T-cell engagers (BiTE), monoclonal antibody)
Prior CD19 targeted therapy, such as CAR-T, Bi-specific T-cell engagers (BiTE), or monoclonal antibody.
Cannot have received: allogeneic hematopoietic stem cell transplant
History of allogeneic HSCT.
Cannot have received: autologous hematopoietic stem cell transplant
Exception: within 3 months prior to consent
History of autologous HSCT within 3 months prior to consent.
Cannot have received: investigational product
Exception: within 4 weeks prior to consent
Received any investigational product within 4 weeks prior to consent.
Cannot have received: systemic anticancer therapy
Exception: within 3 weeks prior to apheresis
Systemic anticancer therapy within 3 weeks prior to apheresis.
Cannot have received: intrathecal chemotherapy
Exception: within 1 week prior to leukapheresis
Intrathecal chemotherapy within 1 week prior to leukapheresis.
Cannot have received: anti-thymocyte globulin
Exception: within 4 weeks prior to consent
Received anti-thymocyte globulin within 4 weeks prior to consent.
Lab requirements
Blood counts
ANC <500/µL; ALC <300/µL (excluding leukemic cells); Hb <8.0 g/dL; Platelet count <75,000/µL (Screening 1) or <50,000/µL (Screening 2) without transfusion support within 3 days
Kidney function
Serum creatinine > 1.5 × ULN and estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m², as calculated by the Cockcroft-Gault formula.
Liver function
AST >5 × ULN and ALT >5 × ULN, or total bilirubin >2 × ULN (except for constitutional jaundice)
Cardiac function
LVEF <50%, QTc >480 msec (Fredericia's formula), clinically significant arrhythmias, history of myocardial infarction or unstable angina within 3 months prior to consent.
Inadequate major organ functions at Screening, which were defined as any of below: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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