NCT06069570招募中1 期
Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T-Cell Infusions in Combination with Low Dose Radiotherapy in Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer or Solid Tumors with Bone Metastases
Kiromic BioPharma Inc.5 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年11月7日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT
研究概览
简要总结
This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.
详细描述
In this clinical trial, or 'study', participants with locally advanced or metastatic, non-small cell cancer (NSCLC) or solid tumors with bone metastases, will receive KB-GDT-01, an allogeneic (cells from healthy donors) gamma delta T-cell product. All participants will receive KB-GDT-01 as intravenous infusions in combination with radiotherapy.
After being informed about the study and its potential risks, during the 28-day screening period, all consented participants will have laboratory tests, assessments, tumor scans, and a tumor biopsy.
Cytokine release syndrome symptoms and other potential adverse effects, will be monitored during the dose limiting toxicity period.
The study will be conducted in 2 parts, with the same number of visits in each part.
In Part 1 Dose Escalation, the study will attempt to identify the best dose with the lowest incidence of adverse effects (AE) and try to identify if the KB-GDT-01 is working (effectiveness). In Part 2 Dose Expansion the best dose will be further investigated for AE and effectiveness. There will be up to 36 participants in Part 1 and up to 21 additional participants in Part 2 of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form.
- •Male or female, > 18 years old.
- •Minimum body weight of 50 kilograms (kg).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC or locally advanced or metastatic solid tumor with bone metastasis
- •Progressed on SOC therapy including platinum-based chemotherapy and immune checkpoint inhibitors (NSCLC), and are not a candidate for further standard anti-neoplastic therapy and/or have exhibited intolerance to and/or declined clinically applicable salvage therapies, and/or have declined therapy.
- •Genomic screening, with tumors with known actionable molecular alterations, such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriate target-directed molecular therapy.
- •At least one measurable target lesion based on RECIST v1.1 confirmed by radiological imaging. Participants with isolated bone metastases are eligible for enrollment are not required to have measurable disease
- •All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1, except for continuing alopecia.
- •Adequate hematopoietic, hepatic and renal function
- •Agree to adequate contraception for up to 120 days after the last dose of study drug.
- •Negative serum pregnancy test for women of childbearing potential
- •All primary and metastatic disease sites are amenable to LDRT
- •For solid tumors with bone metastases subjects (Part 2 Cohort B): receiving zoledronic acid for solid tumors with bone metastases
排除标准
- •Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30 days prior to study Day
- •Major surgery, except for vascular access placement, within the 30 days prior to study Day
- •Active autoimmune disease requiring immunosuppressive therapy.
- •Infection requiring systemic treatment within 30 days prior to study Day
- •History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules.
- •Uncontrolled hypertension, history of arrhythmia including atrial fibrillation, unstable angina, decompensated congestive heart failure, cardiac ejection fraction ≤ 50%, myocardial infarction, or marked baseline prolonged QT/QTc intervals.
- •Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection.
- •Participation in the treatment portion of a clinical trial or completed a clinical trial within the 30 days prior to the first dose of KB-GDT-
- •Presence of any condition that may, in the opinion of the Investigator, render the patient inappropriate from participating in the study.
- •Breastfeeding or pregnant female, or patient is expecting to conceive or father children during the study.
- •Allergy or intolerance to any of the study product ingredients or excipients.
- •Live vaccines administered within 30 days prior to study Day
- •Individuals lacking capacity to consent for themselves.
- •Superior vena cava obstruction
- •Prior radiation therapy to a selected LDRT treatment site </= 30 days prior to Day 1.
研究组 & 干预措施
KB-GDT-01 cells
Experimental
Dose Level 1: 400 x10^6, 800 x10^6 or 1600 x10^6 KB-GDT-01 cells + radiation (1.0 Gy/fraction)
干预措施: KB-GDT-01 (Biological)
结局指标
主要结局
Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT
时间窗: From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later
DLT, defined as the occurrence or start of a clinically significant Grade 3 or greater AE (per CTCAE v5.0) occurring during the DLT assessment period that cannot be attributed to disease progression, intercurrent illness, or concomitant medication.
次要结局
- Objective Response Rate (ORR)(From first study drug infusion through to Month 24)
- Progression Free Survival (PFS)(From first study drug infusion until the first evidence of disease progression, death or Month 24.)
- Time to Progression (TTP)(From first study drug infusion until first evidence of disease progression or Month 24.)
- Overall Survival (OS)(From first study drug infusion until death or Month 24.)
- Time to Treatment Response (TTR)(From first study drug infusion until first evidence of disease response or Month 24.)
- Disease Control Rate (DCR)(From first study drug infusion until first evidence of disease response or stable disease or Month 24.)
研究者
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
1 期
T-Cell Therapy for Advanced Breast CancerMetastatic HER2-negative BreastBreast CancerNCT02792114Memorial Sloan Kettering Cancer Center186
招募中
1 期
Allogeneic γδ T Cell Therapy for the Treatment of Solid TumorsMalignant Solid TumoursNCT04765462Chinese PLA General Hospital60
已完成
1 期
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell MalignanciesB-cell LymphomaDLBCLNon Hodgkin LymphomaPrimary Mediastinal Large B Cell LymphomaMarginal Zone LymphomaFollicular LymphomaB-cell LymphomaDLBCLFollicular LymphomaNCT05653271Acepodia Biotech, Inc.16
招募中
1 期
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)Locally Advanced Solid TumorMetastatic Solid TumorNCT06415487Acepodia Biotech, Inc.30
进行中（未招募）
1 期
Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCTAcute Myeloid LeukemiaNCT05015426H. Lee Moffitt Cancer Center and Research Institute20
相关资讯
Kiromic BioPharma's Deltacel Shows Promising Results in Phase 1 NSCLC Trial- Kiromic BioPharma reports a 33.33% reduction in tumor volume in one patient with metastatic NSCLC after 12 months of Deltacel treatment.
- Another patient in the Deltacel-01 trial achieved a partial response, maintaining progression-free survival for 10 months.
- The seventh patient in the trial experienced a 9.5% reduction in tumor size at the two-month follow-up, indicating early response.
- Kiromic is expanding enrollment in the Deltacel-01 trial to further evaluate the potential of gamma delta T-cell therapy in NSCLC.last yearKiromic BioPharma's Deltacel Shows Promising Results in Lung Cancer Trial- Kiromic BioPharma reports a 32% tumor volume reduction in a patient with stage 4 metastatic NSCLC treated with Deltacel in Phase 1 trial.
- The first patient in the Deltacel-01 trial maintained stable disease with a 27% tumor reduction and 11 months progression-free survival.
- Deltacel, an allogeneic gamma delta T-cell therapy, demonstrates a favorable safety profile with no reported adverse events in treated patients.
- Enrollment continues with the eighth patient now in the Deltacel-01 clinical study at Beverly Hills Cancer Center.last yearCell and Gene Therapies Show Promise in Lung Cancer Treatment• Kiromic BioPharma's Deltacel T-cell therapy demonstrates disease stabilization in NSCLC patients, showing potential in advanced solid tumor treatment.
• Achilles Therapeutics advances neoantigen reactive T-cell therapy trials for NSCLC and melanoma, observing improved T-cell persistence with enhanced conditioning.
• Genprex reports positive results in two lung cancer trials for Reqorsa gene therapy, while discontinuing another, focusing on optimal patient cohorts.
• Viral immunotherapy combo CAN-2409 improves survival in NSCLC patients unresponsive to anti-PD-L1 therapy, reactivating exhausted immune systems.last yearDeltacel Shows Promising Efficacy in Metastatic NSCLC in Phase 1/2 Trial- Deltacel (KB-GDT-01), an allogeneic gamma delta T-cell therapy, demonstrated a 27% reduction in tumor size in a patient with stage IV metastatic NSCLC at 10 months.
- The patient in the Deltacel-01 trial experienced progression-free survival of 10 months with no adverse effects observed, indicating a favorable safety profile.
- Interim data from five evaluable patients showed an average PFS of 4.8 months, with no dose-limiting toxicities reported among patients completing the Deltacel course.
- Kiromic BioPharma anticipates further data from the Deltacel-01 trial in October 2024, potentially reinforcing Deltacel's therapeutic promise.last yearKiromic BioPharma Expands Deltacel-01 Trial for NSCLC to University of Arizona Cancer Center- Kiromic BioPharma has activated the University of Arizona Cancer Center as the fifth clinical trial site for its Deltacel-01 Phase 1 trial.
- The trial evaluates Deltacel™ (KB-GDT-01), an allogeneic gamma delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC).
- The primary objective is to assess safety, with secondary endpoints including objective response and overall survival in patients who have failed standard therapies.
- Patient enrollment at the University of Arizona Cancer Center is expected to commence in the coming weeks, expanding the trial's reach.last year
6 articles
1 / 2