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A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy

RecruitingEARLY Phase 1Ages 18 Years - 70 YearsAllAffiliated Hospital of Nantong University
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In plain words

What the trial is, and whether it could suit you

This study is a single-center, open-label clinical trial of single-dose of CAR T-cells in subjects with relapsed/refractory hematologic malignancy.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patients must meet all of the following criteria to be eligible for the study: 1. Voluntarily participate in the clinical study. The individual or the legal guardian fully understands the study, sign the informed consent form (ICF), and is willing and able to follow and complete all trial procedures. 2. Age ≥ 18 years and \< 70 years. 3. Subjects with refractory or relapsed disease after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation) who are not suitable for other treatment options, such as a second stem cell transplant. The definitions of relapsed/refractory lymphoma include one of the following situations: a. Relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) is defined as one of the following: i) Primary refractory disease. ii) First relapse if the initial remission is ≤ 12 months. iii) Relapse or refractory disease after two or more lines of systemic therapy. iv) Relapse or refractory disease after allogeneic transplantation, provided that at the time of enrollment, the subject is at least 100 days post-stem cell transplantation and has not received immunosuppressive drugs for at least 4 weeks prior to enrollment, except for low-dose steroids (≤ 5 mg of prednisone or equivalent). b. Subjects with Ph+ B-cell ALL, who are intolerant to or ineligible for tyrosine kinase inhibitor (TKI) treatment, or who have relapsed/refractory disease after receiving at least two different TKI treatments, are eligible. c. Relapsed/refractory B-cell-derived non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL) defined as one of the following: i) No response to first-line treatment (primary refractory disease, excluding subjects intolerant to first-line treatment); * Disease progression (PD) as assessed after first-line treatment. * Best response of SD after at least 4 cycles of first-line treatment (e.g., 4 cycles of RCHOP), with SD duration not exceeding 6 months after the last dose. ii) No response to second-line or more treatments. * PD as the best response to the most recent treatment regimen. * Best efficacy of the last line of treatment as SD after at least 2 cycles, with the duration of SD not exceeding 6 months after the last dose. iii) Refractory after autologous stem cell transplant (ASCT). * Disease progression or relapse ≤ 12 months post-ASCT (relapsed patients must have biopsy-proven relapse). * If salvage treatment is performed after ASCT, the subjects must have no response to or relapsed after the last line of treatment. * Relapsed or refractory disease after two or more lines of systemic therapy. 4. Indications included for enrollment in the cohort of anti-CD19-CAR T-cells: 1. CD19+ ALL patients, with bone marrow smear reports showing tumor cells ≥ 5%. 2. CD19+ NHL patients meeting one of the following subtypes: * Diffuse large B-cell Lymphoma, not otherwise specified (DLBCL-NOS) * Primary mediastinal B-cell lymphoma (PMBCL) * Transformed follicular lymphoma (TFL), previously treated for follicular lymphoma and then transformed to refractory DLBCL * Mantle cell lymphoma * High-grade B-cell lymphoma * Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) 5. Subtypes of lymphoma included for enrollment in the cohort of anti-CD20/30-CAR T-cells: * Previously received anti-CD20/30-CAR T-cell therapy, with CD20 expression positive at enrollment. * Lymphoma with dual positive expression of CD20/CD30. 6. Indications included for enrollment in the cohort of anti-CD30-CAR T-cell: * CD30 positive HL * CD30 positive T-cell lymphoma 7. ECOG performance status ≤ 2. 8. Expected survival of at least 12 weeks. 9. Adequate venous access (for apheresis) and no other contraindications for blood cell separation. 10. Laboratory tests during screening must meet the following requirements, and the subject must not have received cell growth factors (long-acting colony-stimulating factors (G-CSF/PEG-CSF) require a 2-week interval) and platelet transfusions within 7 days prior to hematological assessment: 1. Absolute neutrophil count ≥ 1.0×10\^9/L (the condition of ALL patients is determined by the investigator). 2. Hemoglobin ≥ 60 g/L (without red blood cell transfusion in the last 14 days). 3. Platelets ≥ 50×10\^9/L (the condition of ALL patients is determined by the investigator). 4. Absolute lymphocyte count (ALC) ≥ 0.5×10\^9/L. 5. Total serum bilirubin ≤ 1.5× the upper limit of normal (ULN). 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN. 7. Creatinine \<1.5×ULN and estimated creatinine clearance ≥60 mL/min. 11. Ejection fraction ≥ 45%, with echocardiogram (ECHO) confirming no pericardial effusion (excluding small or physiological amounts), and electrocardiogram results with no clinical significance. 12. Baseline oxygen saturation \> 92% without supplemental oxygen. 13. Women of childbearing potential must have a negative serum or urine pregnancy test result (women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered of childbearing potential). Exclusion Criteria: * Subjects are not eligible to participate in this study if they meet any of the following criteria: 1. ALL patients with central nervous system (CNS) abnormalities, including CNS-2 and CNS-3 that are of clinically significant neurological changes: 1. CNS-3 disease is defined as detectable tumor cells in the cerebrospinal fluid (CSF) sample with ≥ 5 WBCs/mm\^3, with or without neurological changes. 2. CNS-2 disease is defined as detectable tumor cells in the CSF sample with \< 5 WBCs/mm\^3 and with neurological changes. Note: Subjects classified as CNS-1 (no detectable tumor cells in CSF) and t
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What it tests

  • anti-CD19-CAR T-cells, or anti-CD30-CAR T-cells, or anti-CD20/CD30-CAR T-cells
  • Fludarabine
  • Cyclophosphamide
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Where

1 site
Affiliated Hospital of Nantong University
Nantong, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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