RecruitingPhase 1NCT07453446
Clinical Study of U29 Injection (CD30-CART) in Patients With CD30-Positive Relapsed/Refractory Lymphoma
A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CD30-targeted Chimeric Antigen Receptor T (CAR-T) Cell Injection in Patients With CD30-positive Relapsed or Refractory Lymphoma
Sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Enrollment
18 participants
Start Date
Mar 4, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria28
- Subjects must provide written informed consent and demonstrate good compliance with study procedures.
- Age between 18 and 70 years, inclusive; male or female.
- Histologically confirmed relapsed or refractory lymphoma (with priority for Hodgkin lymphoma, anaplastic large cell lymphoma, or other lymphoproliferative disorders), with CD30 expression confirmed by immunohistochemistry or flow cytometry (≥50% positive cells).
- Relapsed or refractory disease, defined as:
- \*\*Hodgkin Lymphoma (HL):\*\*
- Failure to achieve remission or disease progression after autologous hematopoietic stem cell transplantation (auto-HSCT); OR
- Failure of at least two prior lines of systemic chemotherapy; OR
- Ineligibility for auto-HSCT due to:
- Chemotherapy resistance (failure to achieve CR or PR after salvage chemotherapy);
- Failed stem cell collection, or investigator-assessed inability to collect, or severe comorbidities, or patient refusal of auto-SCT.
- \*\*Anaplastic Large Cell Lymphoma (ALCL):\*\* Failure of at least two prior lines of systemic chemotherapy or relapse after response.
- \*\*Other CD30+ lymphomas:\*\* No standard treatment options available, or failure after standard therapy.
- At least one evaluable lesion according to the Lugano Classification for Malignant Lymphomas (Cheson 2014).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
- Adequate bone marrow reserve at screening:
- Absolute lymphocyte count (ALC) ≥ 0.3 × 10⁹/L;
- Platelet count (PLT) ≥ 30 × 10⁹/L (transfusion-supported values are acceptable).
- Adequate organ function, defined as:
- Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN);
- Alanine aminotransferase (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.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to CAR-T infusion. All sexually active males and females of childbearing potential must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment.
- Adequate venous access for leukapheresis or blood collection, and no contraindications to leukapheresis.
- Expected survival of at least 3 months.
Exclusion Criteria25
- History of another malignancy, except for malignancies in complete remission for \> 3 years or carcinoma in situ.
- Lymphoma infiltration of the cardiac atria or ventricles.
- Use of immunosuppressive agents or corticosteroids within 1 week prior to leukapheresis, unless the investigator determines that the impact on T cells is minimal.
- Presence of any of the following:
- Positive hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) with HBV-DNA copy number above the lower limit of quantification;
- Positive hepatitis C antibody (HCV-Ab) with HCV-RNA copy number above the lower limit of quantification;
- Positive Treponema pallidum antibody (TP-Ab);
- Positive human immunodeficiency virus (HIV) antibody test.
- Bacterial, fungal, viral, mycoplasmal, or other type of infection that is judged by the investigator to be difficult to control.
- Previous or current central nervous system (CNS) disease unrelated to the current lymphoma, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease, unless judged by the investigator to be controllable.
- Any of the following within 12 months prior to signing informed consent:
- Cardiac angioplasty or stenting;
- New York Heart Association (NYHA) Class III-IV congestive heart failure;
- Myocardial infarction, unstable angina, or other clinically significant cardiac history as judged by the investigator;
- QTc interval \> 480 ms (calculated using the Fridericia formula) at screening;
- Left ventricular ejection fraction (LVEF) \< 50% on echocardiogram.
- Primary immunodeficiency.
- History of severe immediate hypersensitivity reaction to any of the study drugs.
- Administration of a live vaccine within 6 weeks prior to screening.
- Pregnant or lactating female.
- Active autoimmune disease.
- Active acute or chronic graft-versus-host disease (GVHD) at the time of signing informed consent.
- Allogeneic hematopoietic stem cell transplantation within 6 months prior to signing informed consent.
- Participation in any other interventional clinical trial within 30 days prior to signing informed consent.
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
Interventions
DRUGCD30 CAR-T Cells
Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07453446