TCTR20220624004招募中1 期
A Phase I/II Prospective, Single Arm, Multi-Center, Open-Label Trial, to Determine the Safety and Efficacy of Allogeneic Chimeric Antigen Receptor (CAR) - Modified T-Cell Lymphocytes Against CD19 Antigen in Pediatric, Adolescent and Young Adult Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Genepeutic Bio, Co., Ltd0 个研究点目标入组 20 人开始时间: 2022年6月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 3 Years 至 39 Years（—）
- 性别
- All
入选标准
- •Participants need to fulfill all the following inclusion criteria to be included in this study.
- •1) Be between 3 - less than 40 years and diagnosed with B-ALL,
- •2) Has an identified matched allogeneic or haploidentical HSC donor,
- •3) Bone Marrow result demonstrating:
- •Relapsed or refractory disease at one of the following levels:
- •a. BM Blasts less than 5% but MRD positive
- •b. BM Blasts more than or equal 5% but less than or equal 20%,
- •Blast count on BM film (BM smears) will be read by a Thai Board-Certified Haematologist or a Thai Board-certified Paediatric haematologist (either PI or Sub-I of each site). The medical monitor will re-read and confirm the results of the smears. MRD assessment is performed through flow cytometry.
- •Note: BM Blast less than or equal 20% or MRD positive will only be inclusion criteria at screening. This criterion does not apply at pre-lymphodepletion. Therefore, participants who previously had BM Blast less than or equal 20% or MRD positive at screening but have MRD negative at pre-lymphodepletion could be included in the trial.
- •4) All tests below must be met:
- •a. Glomerular Filtration Rate (GFR) less than 60 mL/min/1.73 m2 or serum creatinine less than 1.0 mg/dL (or within normal ranges according to age and sex)
- •b. Aspartate transaminase (AST) Alanine aminotransferase (ALT) less than 5 times the upper limit of the institutional normal ranges
- •c. Bilirubin less than 2.0 mg/dL
- •d. Pulse oxygenation more than or equal 95% on room air
- •e. Left Ventricular Ejection Fraction (LVEF) more than or equal 45% by echocardiogram during the screening period and prior to the start of treatment,
- •5) Have a life expectancy of more than 12 weeks at the time of screening,
- •6) Have access to T cells from their matched related or haploidentical donor,
- •7) Hematologic parameters must meet the following:
- •a. Hemoglobin more than or equal 7.0 g/dL;
- •b. Platelets more than or equal 20,000/mm3 without transfusion support;
- •c. Absolute neutrophil count (ANC) more than or equal 500/mm3 without growth factor support;
- •d. No active hemolytic anemia; and
- •e. No active coagulopathy,
- •8) Karnofsky (age more than or equal 16 years) or Lansky (age less than 16 years) score of more than or equal 50%,
- •9) No restrictive pulmonary disease as measured by FEV1/FVC ratio or if this cannot be done, respiratory exam, chest radiograph, and pulse oximetry as per the investigator judgement,
- •10) The patient or their legally authorized representative has understood the contents of the patient informed consent, and signed and dated the consent form voluntarily prior to all study procedures,
- •11) Are able to comply with study procedures and be available for all study visits,
- •12) Male participants should agree to not donate sperm during study period (i.e. up to 2.5 years
- •following administration of GNPTCD19SPA-0001),
- •13) Male and female participants with reproductive potential must agree to use medically approved contraceptives from when they consent to the study until 12 months after administration of GNPTCD19SPA-0001.
排除标准
- •Participants who meet any of the following exclusion criteria are NOT eligible for this study.
- •1) CD19 negative disease,
- •2) Relapse of the disease in other parts of the body (i.e. extramedullary relapse),
- •3) Detection of blast cells in the cerebrospinal fluid less than 28 days prior to the commencement of the study or displaying neurological abnormalities that may be associated with metastasis such as seizure, weakness or cranial nerve palsies on screening or prior to infusion of GNPTCD19SPA-0001 (chemotherapy given to patients to prevent disease from metastasizing is not considered as an exclusion criteria),
- •4) Diagnosed with chronic graft versus host disease (cGvHD) AND currently receiving immunosuppressive therapy,
- •5) Uncontrolled diabetes mellitus,
- •6) Organ transplant recipients (other than HSC),
- •7) Female participants who are pregnant, plan to become pregnant or return a positive serum human chorionic gonadotropin (beta-HCG) pregnancy test at screening,
- •8) Female participants who are breast feeding or planning to do so for the duration of the study,
- •9) Participants with a history of clinically significant physical or psychiatric conditions, unstable chronic or acute disease, or physical findings that in the opinion of the investigator may increase the risk of exposure to the investigational agent, compromise the safety of the participant, or interfere with any aspect of study conduct or interpretation of results,
- •10) Active, uncontrolled infection, including syphilis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV),
- •11) Planning to travel out of the country during the study period,
- •12) History of alcohol or drug abuse that in the opinion of the investigator could affect the
- •participant safety or compliance with study,
- •13) Any vaccination against infectious disease(s) (e.g., influenza, varicella, COVID-19) less than 6 weeks (42 days) of initiation of study treatment (Day 0),
- •14) Prior treatment with immunotherapy directly targeting T-cells (except anti-thymocyte globulin (ATG)), CD19-directed antibody-based therapies (except blinatumomab), or other gene therapy products,
- •15) Received any investigational drug or investigational anti-cancer therapy within 30 days prior to receiving GNPTCD19SPA-0001 (Day 0),
- •16) Concurrent participation in another therapeutic clinical trial.
- •17) Known allergy to albumin, dimethyl sulfoxide, cyclophosphamide or fludarabine.
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