OncoMatch/Clinical Trials/NCT07453446
Clinical Study of U29 Injection (CD30-CART) in Patients With CD30-Positive Relapsed/Refractory Lymphoma
Is NCT07453446 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD30 CAR-T Cells for relapsed or refractory lymphoma.
Treatment: CD30 CAR-T Cells — This is a single-center, open-label study conducted in subjects with relapsed or refractory CD30-positive lymphoma, with priority given to Hodgkin lymphoma and anaplastic large cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD30 overexpression (≥50% positive cells)
CD30 expression confirmed by immunohistochemistry or flow cytometry (≥50% positive cells)
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: autologous hematopoietic stem cell transplantation — Hodgkin Lymphoma
Failure to achieve remission or disease progression after autologous hematopoietic stem cell transplantation (auto-HSCT)
Must have received: systemic chemotherapy — Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma
Failure of at least two prior lines of systemic chemotherapy
Must have received: standard therapy — Other CD30+ lymphomas
No standard treatment options available, or failure after standard therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: within 6 months prior to signing informed consent
Allogeneic hematopoietic stem cell transplantation within 6 months prior to signing informed consent
Lab requirements
Blood counts
Absolute lymphocyte count (ALC) ≥ 0.3 × 10⁹/L; Platelet count (PLT) ≥ 30 × 10⁹/L (transfusion-supported values are acceptable)
Kidney function
Serum creatinine ≤ 1.5 × ULN OR creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula)
Liver function
AST ≤ 3 × ULN; ALT ≤ 3 × ULN (≤ 5 × ULN if due to tumor infiltration); total serum bilirubin ≤ 2 × ULN, except for Gilbert's syndrome (total bilirubin ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN)
Cardiac function
No more than grade 1 dyspnea, oxygen saturation > 91% on room air; LVEF ≥ 50% on echocardiogram; INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN
Adequate organ function, defined as: AST ≤ 3 × ULN; ALT ≤ 3 × ULN (≤ 5 × ULN if due to tumor infiltration); total serum bilirubin ≤ 2 × ULN, except for Gilbert's syndrome (total bilirubin ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN); Serum creatinine ≤ 1.5 × ULN OR creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula); No more than grade 1 dyspnea, and oxygen saturation > 91% on room air; Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiogram; International Normalized Ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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