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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05326243 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD19 targeted therapy, allogeneic hematopoietic stem cell transplant, autologous hematopoietic stem cell transplant disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression on dominant population of cancer cells is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify