A Clinical Study Exploring CT1190B in the Treatment of Patients with Relapsed/refractory B-cell Non-Hodgkin Lymphoma

Официальное название

A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Обзор

A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma.

Подробное описание

This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1190B cells in patients with B-NHL. It is planned to enroll 6-24 participants.

Вмешательства

• Препарат CAR T cells
  chimeric antigen receptor T cells

Первичные конечные точки

• Adverse Events (AE) after CT1190B infusion [Срок оценки: 12 months after CT1190B infusion]
• MTD and/or dose range [Срок оценки: Up to 28 days after CAR-T cells infusion]

Вторичные конечные точки (7)

• Overall response rate（ORR） [Срок оценки: Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion]
• Complete response rate (CRR) [Срок оценки: 12 months after CT1190B infusion]
• Duration of remission(DOR) [Срок оценки: 12 months after CT1190B infusion]
• Time to response (TTR) [Срок оценки: 12 months after CT1190B infusion]
• Time to complete response (TTCR) [Срок оценки: 12 months after CT1190B infusion]
• Progression-free survival (PFS) [Срок оценки: 12 months after CT1190B infusion]
• Overall survival (OS) [Срок оценки: 12 months after CT1190B infusion]

Критерии участия

Критерии включения

• Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.
• 18-75 years old;
• Histologically or cytologically confirmed B-NHL;
• Previously received at least 2 lines of systemic therapy;
• Intolerance to last treatment, or have progressed on or after the last treatment and currently require therapy;
• There are measurable target lesions;
• Expected survival > 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) score 0-1;
• Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy and are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating eggs for 1 year after receiving study treatment infusion during the study; male participants are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment if they are sexually active with a female of childbearing potential. Sperm donation is absolutely prohibited for 1 year after receiving study treatment infusions during the study for all male participants.

Критерии исключения

• Pregnant or lactating women;
• Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-DNA positive);
• Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);
• Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator;
• Has received treatment for the disease within 14 days before informed consent, including but not limited to cytotoxic therapy, monoclonal antibodies or ADCs, targeted therapy, radiotherapy, epigenetic therapy, or investigational agents, or invasive investigational medical devices within 14 days before informed consent. If the radiation field covers ≤ 5% of the bone marrow reserve, the participant is eligible regardless of the end date of radiotherapy;
• Systemic glucocorticoids equivalent to > 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;
• Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;
• Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;
• Patients with any heart disease in the 6 months prior to screening;
• Oxygen saturation < 92%,;
• Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;
• Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract);
• Participants are unable or unwilling to comply with the requirements of the study protocol or are otherwise unsuitable for participating in this clinical study in the investigator 's assessment;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Tongji Hospital — Шанхай

Идентификаторы

NCT: NCT06734871 · CT1190B-CG11001_02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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