OncoMatch/Clinical Trials/NCT06014762
P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
Is NCT06014762 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including P-CD19CD20-ALLO1 and Rimiducid for diffuse large b-cell lymphoma, not otherwise specified.
Treatment: P-CD19CD20-ALLO1 · Rimiducid — Phase 1 study comprised of open-label, dose escalation and expansion cohort study of P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory B cell malignancies
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemoimmunotherapy (anti-CD20 antibody, anthracycline) — first-line
Prior systemic chemotherapy must include a line of chemoimmunotherapy that includes an anti-CD20 antibody, an anthracycline
Cannot have received: non-mAb anti-cancer medications
Has received non-mAb anti-cancer medications within 2 weeks of the time of initiating LD chemotherapy.
Cannot have received: monoclonal antibody therapy
Has received mAb therapy within 4 weeks of initiating LD chemotherapy.
Cannot have received: immunosuppressive medications
Has received immunosuppressive medications within 2 weeks of the time of administration of P-CD19CD20-ALLO1, and/or expected to require them while on study
Cannot have received: systemic corticosteroid
Exception: topical and inhaled steroids permitted; systemic corticosteroids contraindicated after receiving P-CD19CD20-ALLO1 cells outside of study-specific guidance or medical monitor approval
Has received systemic corticosteroid therapy > 5 mg/day of prednisone or equivalent dose of another corticosteroid within 1 week or 5 half-lives (whichever is shorter) of the administration of P-CD19CD20-ALLO1 or is expected to require it during the course of the study.
Cannot have received: allogeneic or xenogeneic transplant
Exception: Subjects with prior history of allogeneic stem cell transplant may be enrolled if they are not on immunosuppressive medications and with medical monitor approval.
Has a history of having undergone allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days.
Cannot have received: allogeneic genetically modified cellular therapy
Has received prior allogeneic genetically modified cellular therapy or was treated with experimental allogeneic cell therapy.
Lab requirements
Blood counts
ANC ≥ 1000/μL (no G-CSF within 7 days or peg-G-CSF within 14 days), platelets ≥ 50,000/μL (no transfusion within 7 days), hemoglobin ≥ 8 g/dL (no transfusion within 7 days)
Kidney function
Serum creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 30 mL/min and not dialysis-dependent
Liver function
AST and ALT ≤ 3 × ULN, total bilirubin ≤ 2.0 mg/dL (≤ 3 mg/dL if Gilbert's Syndrome)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 45% (within 4 weeks of enrollment)
Must have adequate vital organ function, defined as follows (or medical monitor approval): Serum creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 30 mL/min and not dialysis-dependent. Adequate hematologic function, including: ANC ≥ 1000/μL in the absence of growth factor support (granulocyte colony stimulating factor [G-CSF] within 7 days or peg-G-CSF within 14 days) Platelet count ≥ 50,000/μL in the absence of transfusion support (platelet transfusion within 7 days) Hemoglobin ≥ 8 g/dL in the absence of transfusion support (red blood cell count or whole blood within 7 days) AST and ALT ≤ 3 × ULN, total bilirubin ≤ 2.0 mg/dL (unless there is a history of Gilbert's Syndrome in which case bilirubin levels ≤ 3 mg/dL). Left ventricular ejection fraction (LVEF) ≥ 45%. LVEF assessment must have been performed within 4 weeks of enrollment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Diego · La Jolla, California
- Loma Linda University Cancer Center · Loma Linda, California
- Cedars-Sinai Medical Center · Los Angeles, California
- Advent Health Orlando · Orlando, Florida
- Indiana University · Indianapolis, Indiana
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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