RD14-01 Cell injection

Changsong Qi, Dr.

Lin Shen, Prof. Dr.

This study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors.

This single-arm, open-label, dose-escalation and dose-expansion study will evaluate the safety and tolerability of RD14-01, ROR1-targeting CAR T cells, in adults with ROR1+ advanced solid tumors. The dose-escalation phase will investigate 3 dose levels to the. The dose-expansion phase will enroll .

A Study of RD14-01 in Patients With Advanced Solid Tumors

Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)

Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence.

Overall Response Rate (ORR) by RECIST, version 1.1

Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples

Time to Cmax (Tmax) of RD14-01 in peripheral blood (PB) samples

Persistence of RD14-01 CAR T cells in peripheral blood samples

Shen Lin

Professor

Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Sarcoma

Breast Diseases

Skin Diseases

Soft Tissue Sarcoma

All Drugs and Chemicals

Antibodies

Immunoglobulins

Escalating doses of NBE-002 depending on cohort at enrollment.

Dose to be determined based on DEC and SEC.

NBE-002 will be given intravenously on Day 1 of repeated 28-day cycles.

NBE-002

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of NBE-002, a novel anti-ROR1 antibody-drug conjugate, in patients with advanced solid tumors.

NBE-002 in Patients With Advanced Solid Tumors

A First-in-Human, Phase 1/2 Study of NBE-002, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced Solid Tumors

The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

Anti-tumor activity will be assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

Safety and tolerability profile will be assessed by Common Terminology Criteria for Adverse Events v5.0 and summarized by type, frequency, and severity of adverse events

Preliminary anti-tumor activity will be assessed by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

Pharmacokinetic profile will be characterized by concentrations of NBE-002

Immunogenicity profile will be characterized by concentrations of NBE-002-reactive antibodies

Cmed Clinical Services

NBE-Therapeutics AG

Subjects who meet the enrollment conditions will receive intravenous infusion of anti--ROR1 CAR-T Cells after lymphodepleting therapy.

RD14-01

Sanbin Wang, Doctor

This single-arm, open-label, dose-escalation and dose-expansion study will evaluate the safety and tolerability of RD14-01, ROR1-targeting CAR T cells, in adults with ROR1+ advanced solid tumors.

A Phase1/phase2，Single-arm, Open-label Study of RD14-01 in Patients With Advanced Solid Tumors

Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Docetaxel

Tubulin Modulators

Antimitotic Agents

There is only one treatment arm on this study. The combination of cirmtuzumab + docetaxel will be administered on one treatment arm. Treatment will cirmtuzumab will be administered initially as a loading dose alone on days 1, 15, and 29 of cycle 1. Following the loading, cirmtuzumab will be given on Day 1 of every 21-day cycle starting on Cycle 2 to up to Cycle 7 corresponding with concurrent docetaxel administration. Following discontinuation or completion of docetaxel, treatment with cirmtuzumab will be continued Day 1 of every 28 cycle until disease progression, toxicity or study withdrawal. Docetaxel will be administered on day 1 of every 21-day cycle starting Cycle 2 for up to 6 cycles.

Cirmtuzumab will be given in combination with docetaxel.

Cirmtuzumab

Rana R McKay, MD

Rana McKay

The purpose of this study is to examine the safety and efficacy of cirmtuzumab in combination with standard of care docetaxel in patients with metastatic castration resistant prostate cancer. Docetaxel is a taxane chemotherapy which has been shown to prolong survival in men with castration resistant prostate cancer. Cirmtuzumab is a monoclonal antibody that targets the receptor called ROR1 of the non-canonical Wnt pathway and is suspected to contribute to prostate cancer growth and progression.

This study seeks to targeting the non-canonical Wnt pathway with an antibody against ROR1. ROR1 is an attractive target given its low expression in non-malignant tissues and its role in proliferation and survival in prostate cancer. From preclinical data in a variety of tumor types, blockade of ROR1 inhibits cell growth and cirmtuzumab has shown efficacy in clinical trials with CLL. Preclinical data suggests that ROR1 is upregulated in chemotherapy resistant cells and treatment with cirmtuzumab and a taxane achieved higher cytotoxic response than both agents alone, supporting the use of the combination of cirmtuzumab and a taxane. Based on the biological rationale behind cirmtuzumab and preclinical activity with docetaxel, this is an open label, phase 2 clinical trial to evaluate the safety and efficacy of cirmtuzumab in combination with docetaxel for the treatment of metastatic, castrate resistant prostate adenocarcinoma.

Study of Docetaxel Combined With Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer

A Phase 1b Trial Investigating Docetaxel Combined With Cirmtuzumab in Patients With Metastatic Castration Resistant Prostate Cancer

Defined as a reduction of ≥30% from the baseline value, confirmed ≥4 weeks later.

Defined as an increase of ≥25% from baseline at ≥12 weeks, in patients with no decrease from baseline, or as an increase of ≥25% above the nadir, confirmed ≥3 weeks later, in patients with an initial decrease from baseline.

Defined by PCWG-3 criteria for bone metastases and RECIST version 1.1 for soft tissue

Time from study discontinuation to initiation of subsequent systemic anti-cancer therapy or death

Time to first symptomatic pathologic fracture, radiation to the bone given symptomatic bone metastasis, surgery to the bone given symptomatic bone metastasis, or symptomatic spinal cord compression

Time from enrollment to death or last follow up

Composite endpoint of clinical benefit defined as any one of the following: PSA response by PCWG3 criteria, objective response rate by RECIST version 1.1, and stable disease \> 6 months by RECIST version 1.1.

University of California, San Diego

Associate Professor of Medicine and Urology

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Immunomodulating Agents

Jackie Walling, MD, PhD

Biomarker Screening Protocol for Preliminary Eligibility Determination for Adoptive T-cell Therapy Trials:This is a decentralized, multi-site, US-based biomarker screening study to identify participants who have specific disease indications and tumor expression of target(s) of interest that may inform eligibility for active and future Lyell clinical trials. No investigational treatments will be administered in this non-interventional screening study. Only previously obtained archival tumor tissue will be allowed on this study for biomarker analysis. Fresh tumor biopsies are not permitted on this study. The study will be conducted virtually and participants will utilize telehealth and e-consent modules. If participants tumors express the biomarkers of interest they can be referred to open and enrolling clinical trials. Participation on the screening study does not guarantee enrollment or treatment on an interventional clinical trial.

An Archival tumor tissue sample collected within 3 years prior to enrollment. The sample must consist, at minimum, of 5 freshly cut, unstained 4-5 μM sections cut from a formalin-fixed paraffin-embedded (FFPE) tissue block. The sample must contain sufficient tumor tissue to allow for the evaluation of biomarker expression

A Biomarker Screening Protocol for Participants With Solid Tumors

A Biomarker Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive T-cell Therapies in Participants With Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of RD14-01 in Patients With Advanced Solid Tumors	NCT05638828	Solid Tumor	RD14-01 Cell in...	18 Years -	Peking University
NBE-002 in Patients With Advanced Solid Tumors	NCT04441099	Advanced Solid ... Advanced Cancer Triple Negative...	NBE-002	18 Years -	NBE-Therapeutics AG
A Study of RD14-01 in Patients With Advanced Solid Tumors	NCT05748938	Solid Tumor	RD14-01	18 Years - 70 Years	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study of Docetaxel Combined With Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer	NCT05156905	Metastatic Cast...	Cirmtuzumab	18 Years -	University of California, San Diego
A Study of RD14-01 in Patients With Advanced Solid Tumors	NCT05748938	Solid Tumor	RD14-01	18 Years - 70 Years	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
A Study of RD14-01 in Patients With Advanced Solid Tumors	NCT05748938	Solid Tumor	RD14-01	18 Years - 70 Years	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study of Docetaxel Combined With Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer	NCT05156905	Metastatic Cast...	Cirmtuzumab	18 Years -	University of California, San Diego
A Biomarker Screening Protocol for Participants With Solid Tumors	NCT05891197	Triple Negative... Nonsmall Cell L...		18 Years - 99 Years	Lyell Immunopharma, Inc.
NBE-002 in Patients With Advanced Solid Tumors	NCT04441099	Advanced Solid ... Advanced Cancer Triple Negative...	NBE-002	18 Years -	NBE-Therapeutics AG

Spots Global Cancer Trial Database for ror1

Every month we try and update this database with for ror1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ror1

Every month we try and update this database with for ror1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ror1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.