CTRI/2024/10/074924招募中1/2 期
A Prospective, Single-Arm, Open-Label, Multi-Center, Phase 1/2 Study of the Safety and Efficacy of MyCART-01 in Patients with CD19 positive Relapsed or Refractory B Cell Malignancies
Micro CRISPR Private Limited12 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2024年10月28日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 41
- 试验地点
- 12
- 主要终点
- The incidence of adverse events, defined as safety evaluation
研究概览
简要总结
This study is a prospective, single-arm, open-label, multi-center clinical trial designed to evaluate the safety and efficacy of MyCART-01 in patients with CD19+ relapsed or refractory B cell malignancies. The trial encompasses two phases, I and II, with a total intended enrollment of 41 participants, including both ALL (Acute Lymphoblastic Leukemia) and NHL (Non-Hodgkin Lymphoma) patients.
Phase I involves the inclusion of 10 patients, comprising 7 adults (with at least 1 from either ALL or NHL) and 3 pediatric patients with ALL. Following Phase I, Phase II aims to enroll an additional 31 patients, distributed between Stage I (14 patients) and Stage II (17 patients).
The investigational product under evaluation is Mycabtagene Autoleaucel, denoted as MyCART-01. This therapy falls under the category of CAR-T (Chimeric Antigen Receptor T-cell) and is designed to target CD19, a protein expressed on the surface of B cells.
The study is currently in the I/II phase of development and is being conducted at approximately seven centers in India. The primary endpoint is to assess the safety and efficacy of MyCART-01 in treating CD19+ relapsed or refractory B cell malignancies.
Following the CAR-T infusion, participants will be monitored for a period of two years during the follow-up phase. The outcomes of this study will contribute valuable insights into the potential of MyCART-01 as a therapeutic intervention for patients with relapsed or refractory B cell malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Non Hodgkin’s Lymphoma: 1)Non Hodgkins Lymphoma Patients with age greater than or equal to 18 years.
- •Patients with relapsed or refractory B Cell NHL with histologically confirmed diagnosis of one of the following a)DLBCL NOS b)high grade B Cell lymphoma with MYC and BCL2 and or BCL6 rearrangements c) transformed FL d)mantle cell lymphoma e)grade 3b FL f)Richters transformation of CLL g)Other forms of B cell NHL Note: i)For refractory disease patients must have progressive disease on last therapy, or have stable disease following at least 2 lines of therapy with duration of stable disease of less than or equal to 6 months ii)For patients with transformed FL, patients must have received at least one line of chemotherapy for disease after transformation to DLBCL and have progressed or relapsed within 12 months 3) Refractory or relapsed disease, to prior first line therapy, including an anti CD20 monoclonal antibody and an anthracycline containing regimen 4) Patients with prior autologous hematopoietic stem cell transplant must not have traces of related toxicities.
- •At least 1 measurable lesion that is fluorodeoxy glucose positron emission tomography positive, as defined by Lugano criteria Note: Previously irradiated lesions will be considered measurable only if progression is documented following g completion of radiation therapy.
- •Acute Lymphoblastic leukemia Acute Lymphoblastic Leukemia: 1)Adult patients of age greater than or equal to 18 years and children of age greater than or equal to 3 years 2)Diagnosed with the histologically confirmed CD19 positive relapsed or refractory adult or pediatric B Cell ALL a)Refractory disease is defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or after completion of induction phase of pediatric regimens or b)Relapsed disease as defined by bone marrow relapse at any point of time after achieving CR 1 3)Philadelphia chromosome positive Ph positive ALL patients 4)Confirmation from central pathology lab i)Documentation of CD19 tumor expression in bone marrow by flow cytometryII ii)Bone marrow with greater than or equal to 5 percent lymphoblasts For all patients: 1)Eastern Cooperative Oncology Group performance status 0 to 1 2)Life expectancy greater than or equal to 12 weeks 3)Patients with absolute lymphocyte count of greater than or equal to 0.2 into 109 per L 4)Female patients of childbearing potential post menarcheal with an intact uterus and at least 1 ovary, who are less than 1 year postmenopausal must agree to use acceptable method of contraception from enrollment through at least 12 months after CAR T infusion.
- •Male patients must agree to use effective contraception from enrollment through at least 12 months after CAR T infusion 5)Adequate organ function based on investigators discretion but not limited to the following points: i)Renal: Estimated glomerular filtration rate greater than 50 ml min 1.73 m2 ii)Liver: Aspartate transaminase or alanine transaminase less than 3 upper limit of normal total bilirubin less than 1.5 ULN for patients with Gilberts syndrome total bilirubin less than 3 mg dL iii)Cardiac: Hemodynamically stable and left ventricle ejection fraction greater than or equal to 45percent by echocardiogram iv)Pulmonary Oxygen saturation level on room air greater than or equal to 91percent per pulse oximetry 6) Written voluntary informed consent (adults) or parental/guardian consent for children aged 3 to 11 and assent form for adolescent aged 12 to 17 years who are able to give written assent prior to performing any research related tests or procedures.
排除标准
- •Eligible for and agrees to allogeneic HSCT 2)Treatment with the following therapies as described below a) Prior treatment with any gene therapy or genetically modified cell therapy, including CAR-T Cells b) Prior treatment with a CD19-directed antibody, bispecific T Cell engager, or antibody drug conjugate, unless there is confirmed CD19 expression by immunohistochemistry or flow cytometry after progression or relapse following most recent CD19 directed treatment.
- •Prior allogenic HSCT 4)Prior anaphylactic reaction to Cyclophosphamide, Fludarabine or any of the excipients of CART product 5) History of a seizure disorder, cerebrovascular ischemia or hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement 6)Unstable angina, clinically significant arrhythmia, or myocardial infarction within 12 months of enrollment 7) Presence of active bacterial, viral, or fungal infection 8)Positive for presence of human immunodeficiency virus type 1 or 2, or active hepatitis B virus orhepatitis C virus infection or other viral infections.
- •Patients with prior history of hepatitis B or C infection who have documented undetectable viral load by quantitative polymerase chain reaction or nucleic acid testing may be permitted 9) Patients have active SARS COV-2 positive RT PCR test infection at the time of screening.
- •Any condition leading to T Cell depletion, rendering patient unsuitable for CAR T Cell therapy 11) Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely treated and has been in remission for greater than or equal to 5 years 12) Patient underwent radiation therapy before 14 days of enrollment 13) Use of systemic anti tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment.
- •An exception is made for prior inhibitory or stimulatory immune checkpoint molecule therapy, which is prohibited within 3 half lives of enrollment 14) Primary immunodeficiency disorder or active autoimmune disease requiring steroids and or other immunosuppressive therapy 15) Diagnosis of significant psychiatric disorder or other medical condition that, in the opinion of the investigator, could impede the patient’s ability to participate in the study 16) Women who are pregnant or breastfeeding 17) Any condition, in opinion of the Investigator or Screening committee, would preclude safe participation of patient in the study.
结局指标
主要结局
The incidence of adverse events, defined as safety evaluation
时间窗: 30 Days
Evaluating the objective response rate (complete response (CR) + partial response(PR)) per the Lugano Response Criteria for malignant lymphoma
时间窗: 30 Days
Evaluating the objective response rate in pediatric and young adult CD19+ relapsed or refractory B cell ALL, based on CR and complete remission with incomplete count recovery (CRi)
时间窗: 30 Days
次要结局
- Evaluating the objective response rate (complete response (CR) + partial response(PR)) per the Lugano Response Criteria for malignant lymphoma(3 Months)
- Duration of response(Progression-free survival (central read))
研究者
Dr Dinesh Pendharkar
Sarvodaya Hospital, Faridabad
研究点 (12)
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