癌研連線CancerLink
招募中 NCT05475925

DR-01在大颗粒淋巴球性白血病或细胞毒性淋巴瘤受试者中的研究

淋巴瘤白血病皮肤癌Phase IMET

这是一项多中心、首次人体1/2期研究，旨在评估DR-01在大颗粒淋巴细胞白血病或细胞毒性淋巴瘤成人患者中的安全性、耐受性、药物动力学、药效学和抗肿瘤活性

适应症：LGLL - Large Granular Lymphocytic Leukemia、Primary Cutaneous Gamma-Delta T-Cell Lymphoma、Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma、Hepatosplenic T-cell Lymphoma、Subcutaneous Panniculitis-Like T-Cell Lymphoma、Aggressive NK Cell Leukemia、Systemic EBV1 T-cell Lymphoma, if CD8 Positive、Hydroa Vacciniforme-Like Lymphoproliferative Disorder、Extranodal NK/T Cell Lymphoma, Nasal Type、Enteropathy-Associated T-Cell Lymphoma、Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma、Cytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)、Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)

入组条件

纳入标准

  • ≥18 years of age.
  • Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.
  • Sufficient key organ performance and coagulation.
  • Female subjects of childbearing potential (postmenarcheal, has an intact uterus and at least one ovary, and is \<1 year postmenopausal) must agree to use a highly effective method of contraception from enrollment through at least 12 months after last dose of DR-01.
  • Male subjects must agree to use acceptable effective method(s) of contraception.
  • Must have discontinued at least one prior line of systemic therapy.
  • Additional immunophenotypic and symptomatic criteria must be met.
  • Subjects must have failed at least one prior systemic regimens.
  • Availability of post-progression tissue sample or willingness to consent to a baseline biopsy.
  • Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification \[Swerdlow 2016\]).
  • For Part A only, evaluable disease is acceptable.
  • For Part B2 only, evaluable by the following response criteria as documented during Screening:
  • For cytotoxic PTCL-NOS, ENKTL, MEITL, EATL, SPTCL - Subjects must have radiographically measurable disease by computed tomography (CT) or CT/positron emission tomography (PET) scan defined as at least one node measuring \>1.5 cm or measurable extranodal lesion of at least 1.0 cm in longest diameter to be evaluated by Lugano criteria (Cheson 2014).
  • For PCGDTCL, ET-CTCL, HVLPD, cytotoxic CuPTCL-NOS - Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or have leukemic involvement that can be evaluated using modified TPLL response criteria (Staber 2019).
  • For HSTCL, ANKL, SysEBV TCL - Subjects with hepatosplenic disease without measurable disease by Lugano criteria (Cheson 2014) or leukemic involvement in BM or peripheral blood that is evaluable for response using a modified TPLL response criteria (Staber 2019).
  • Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days
  • Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT.
  • Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexus blockade).

排除标准

  • A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.
  • Active or suspected malignant central nervous system involvement.
  • Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).
  • Active known second malignancy.
  • Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2).
  • Hepatitis B infection (hepatitis B virus surface antigen \[HBsAg\] positive), or hepatitis C (hepatitis C virus \[HCV\] antibody positive, confirmed by HCV ribonucleic acid). Subjects with HCV with undetectable virus after treatment are eligible.
  • History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.
  • Use of systemic corticosteroids at prohibited dose levels within 15 days prior to C1D1 (except for prophylaxis for radiodiagnostic contrast reactions and study-defined premedication) or use of other non-biological immunosuppressive drugs within 15 days or 5 half-lives (whichever is less) prior to C1D1.
  • Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy).
  • Any other medical or psychiatric condition, or laboratory abnormality that would increase the risk associated with study participation, in the opinion of the Investigator or Medical Monitor.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。