NCT07485504尚未招募1 期
A Prospective, Single-Arm Study Evaluating the Safety and Efficacy of DIT101 in Subjects With Relapsed or Refractory Hematologic Malignancies
Tcelltech Inc.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年4月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety#Incidence and severity of adverse events (AEs)
研究概览
简要总结
This study is a single-arm, open-label clinical trial designed to evaluate the safety and tolerability of DIT101 in adults with relapsed or refractory hematologic malignancies and to explore its potential anti-tumor effects.
DIT101 is an investigational in vivo CAR-T cell therapy administered by intravenous infusion. After administration, it is intended to generate CAR-T cells within the patient's body that can recognize and attack tumor cells. Unlike approved autologous CAR-T therapies, DIT101 does not require collection and ex vivo genetic modification of the participant's own cells.
The study includes a screening period, DIT101 infusion treatment, a post-treatment intensive follow-up period of approximately 6 months, and a long-term follow-up period of up to 2 years, with visits every 3-6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to <70 years, any gender.
- •Voluntarily provide written informed consent and willing to comply with all study procedures.
- •Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL), or other relapsed/refractory hematologic malignancies as judged by the investigator and confirmed by the collaborating institution.
- •Tumor cells confirmed positive for the target antigen by immunophenotyping.
- •Bone marrow blast ≥5% at screening and/or presence of extramedullary disease.
- •For B-ALL/LBL patients, meets criteria for relapsed/refractory disease, including:
- •Primary refractory after ≥2 cycles of standard chemotherapy or not achieving CR after multiple salvage regimens;
- •Relapse within 12 months after CR or ≥12 months relapse after CR not achieving CR after subsequent standard therapy;
- •Relapse after hematopoietic stem cell transplantation;
- •Relapse after prior CAR-T therapy targeting the same antigen.
- •ECOG performance status 0-
- •Expected survival >3 months.
- •Adequate organ function, including:
- •Renal: creatinine clearance >45 mL/min;
- •Hepatic: total bilirubin ≤3×ULN, ALT/AST ≤5×ULN;
- •Coagulation: PT, APTT, or INR ≤1.5×ULN;
- •Cardiac: LVEF ≥50% within 1 month;
- •Pulmonary: SpO₂ ≥92% at rest on room air;
- •Hematologic and immune function considered sufficient to tolerate study treatment.
- •Women of childbearing potential must have a negative pregnancy test; women considered not of childbearing potential include those who are postmenopausal for ≥12 months or have undergone surgical sterilization (hysterectomy or bilateral oophorectomy).
排除标准
- •Pregnant or breastfeeding women.
- •Known hereditary bone marrow failure syndromes (e.g., Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known marrow failure syndromes).
- •Uncontrolled active central nervous system leukemia (CNSL; CNS2 or CNS3).
- •Prior anti-cancer therapy before screening, including:
- •Systemic chemotherapy within 1 week;
- •Systemic immunotherapy/targeted therapy (monoclonal antibodies, bispecific antibodies, ADCs, etc.) with last dose <5 half-lives or <4 weeks (whichever is shorter);
- •Donor lymphocyte infusion within 6 weeks;
- •CAR-T therapy or hematopoietic stem cell transplantation within 3 months;
- •Radiotherapy within 4 weeks (unless bone marrow reserve >5% and investigator judges it does not affect eligibility);
- •Persistent clinically significant toxicity from prior therapy not recovered to ≤CTCAE Grade 1 (except alopecia).
- •Uncontrolled severe active infection.
- •History of significant cardiac disease, including: severe heart failure (NYHA class III-IV), myocardial infarction or PCI/stent within 12 months, unstable angina, QTc >480 ms, or other clinically significant arrhythmia per investigator judgment.
- •History of CNS injury, seizure, stroke, or brain hemorrhage requiring treatment within 6 months.
- •Active viral infections:
- •HIV antibody positive, syphilis serology positive;
- •HBsAg >10⁶ IU/mL;
- •HCV antibody positive;
- •EBV positive (EBER or copy number above normal).
- •Need for long-term systemic corticosteroid therapy during DIT-101 infusion (local or inhaled steroids allowed).
- •Active autoimmune disease requiring treatment, immunodeficiency, or use of immunosuppressive therapy.
- •Acute or moderate-to-severe chronic graft-versus-host disease (GvHD) within 4 weeks prior to screening.
- •Known severe allergy to any component of DIT-
- •Women of childbearing potential or men unable to use effective contraception during DIT-101 infusion and for 1 year post-infusion; plans for pregnancy within 1 year post-infusion in male or female subjects or their partners.
- •Any condition that, in the investigator's opinion, may increase risk or interfere with study outcomes.
- •Prior malignancy other than hematologic malignancy, except:
- •Malignancy treated with curative intent and disease-free ≥2 years;
- •Non-melanoma skin cancer adequately treated with no current evidence of disease.
结局指标
主要结局
Safety#Incidence and severity of adverse events (AEs)
时间窗: 2 years after completion of the DIT101 infusion or until death, whichever occurs first.
To evaluate the possible adverse events after DIT101 infusion, including the incidence, and severity of AEs
Safety#Incidence of Dose Limiting Toxicity (DLT)
时间窗: 28 days after the first DIT101 infusion.
Incidence of dose limiting toxicities (DLTs) within 28 days after the first DIT101 infusion.
次要结局
- Duration of Remission (DOR)(2 years after completion of the DIT101 infusion or until death, whichever occurs first.)
- Event-Free Survival (EFS)(2 years after completion of the DIT101 infusion or until death, whichever occurs first.)
- Leukemia-Free Survival (LFS)(2 years after completion of the DIT101 infusion or until death, whichever occurs first.)
- Proportion of Responding Subjects Receiving HSCT(Up to 2 years following the completion of DIT101 infusion.)
- Overall Survival (OS)(Up to 2 years after DIT101 infusion or until death, whichever occurs first.)
- Maximum Concentration (Cmax) of CAR-T Cells in Peripheral Blood(up to 2 years after completion of the DIT101 infusion or until death, whichever occurs first.)
研究者
研究点 (1)
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