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Safety Evaluations Safety of CLBR001/ SWI019 in patients with FL will be evaluated based on criteria described by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Adverse events will be assessed continuously during the study and for 100 days after the last study d... |
Statistical Methods: For continuous variables, descriptive statistics (mean, SD, interquartiles and ranges) will be presented; for categorical variables, counts and percentages will be tabulated by cohort. Assessment of CR and OS will also be presented in tabular format. For safety-related parameters (ie, clinical sign... |
Statistical Analysis Plan: To be determined |
Study Hypothesis: The combination of CLBR001/ SWI019 is safe and well tolerated in adult patients with FL. |
Sample Size: Statistics were not used to calculate the proposed sample size of 36 patients. The anticipated drop-out rate is 30%. |
Pharmacokinetic Methods: CLBR001 cells will be monitored by a flow cytometry based assay to determine cells/uL of blood and separately be a qPCR based assay to vector copy number per ug of DNA. SWI001 will be quantified in serum by a sandwich based ELISA assay. |
Pharmacokinetic Population All patients treated with SWI019 who provide at least 1 valid concentration value will comprise the PK Population. The PK Population will be used for the analysis of PK data. The PK exposure-response analysis will include patients who have both available PK and PK/pharmacodynamics response da... |
Efficacy Analyses: Populations for Analysis There are three analysis populations for this study, as follows: the Full Analysis (FA) Population, the Safety Population, and the PK Population. Full Analysis Population The FA Population will include all enrolled patients that had at least one postbaseline observation. Full... |
Safety Analyses: All enrolled patients will be included in the Safety Population. Safety analyses will be based upon the treatment regimens actually received. |
Date of Protocol Synopsis: January 19th, 2018 |
APPENDIX |
'RESPONSE DEFINITIONS' |
Response Category Definition |
Complete remission (CR) All of the following criteria are met: Bone Marrow Peripheral Blood • Neutrophils > 1x 10e9/L, and • Platelets > 100 x 10e9/L, and • Circulating blasts < 1% Extramedullary disease • No evidence of extramedullary disease (by physical exam, spinal tap (D 28 or to ascertain CR/CR;), and symptom Tra... |
Complete remission with incomplete blood count recovery (CRi) All criteria for CR as defined above are met, except that the following exist: • Neutrophils ≤ 1x 10e9/L, and/or • Platelets ≤ 100 x 10e9/L and/or • Platelet and/or neutrophil transfusions ≤ 7 days before peripheral blood sample for disease assessment |
Relapsed Disease Only in patients who obtained a CR or CRi: • Reappearance of blasts in the blood (≥1%), or • Reappearance of blasts in the bone marrow (≥5%), or • (Re-)appearance of any extra-medullary disease after CR or CRi |
Source: National Comprehensive Cancer Network (NCCN) guidelines for response |
Table of Study Events Dosing Schedule CLBR001/ SWI019 IV QAD, Hospitalization 1st Cycle for 28 days |
Dosing Period Recovery Period Assessment Cycle 11 Screening/ Baseline Week -1 Week 1 Week 2 Week 3 Week 4 |
Study Day # Day -28 to Day-1 Day -4 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 |
Calendar Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 |
Informed Consent X |
Inclusion/Exclusion X |
Demographic Information X |
Medical History X |
Physical Examination X X X X X |
Height X |
Weight X X X X X |
12-Lead ECG X X X X X |
Eastern Cooperative Oncology Group Performance Status X X |
HBV, HCV, and HIV X |
Serology X |
PK X X X X X X X X X X X X X X X X X |
ADA X X X |
IP administration intravenously CLBR001 single dose X |
SWI019 X X X X X X X |
Adverse Events/Serious Adverse events X X X X X X X X X X X X X X X X X X X X X X X X X X X X X |
Chemistry, Hematology, and Urinalysis X X X X X X X X X X X X X X X X X |
Prior and Concomitant Medications/ Nonpharmacologic therapies X X X |
CTC X X X |
Bone Marrow Biopsy X X X |
Archival Bone Marrow Sample X |
Exploratory biomarkers X X X X X X X X X X |
1Assessment Cycle 1 - Patients will be admitted to the hospital for a period of approximately 28 days, i.e. from week -1 to week 3 (inclusive); single IV administration of CLBR001 CAR-T cells and subsequent IV administration of SWI019 Switch peptide every other day for week 1 and 2 followed by a recovery period from D1... |
Table of Study Events Dosing Schedule CLBR001/ SWI019 IV QAD, Second Cycle etc. |
Dosing Period Recovery Period Assessment Cycle 2 Week 1 Week 2 Week 3 Week 4 |
Study Day # 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 |
Calendar Day 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 |
Informed Consent |
Inclusion/Exclusion |
Demographic Information |
Medical History |
Physical Examination X X X X X X X |
Height |
Weight X X X X X X X |
12-Lead ECG X |
Eastern Cooperative Oncology Group Performance Status X X X |
HBV, HCV, and HIV |
Serology |
PK X X X X X X X |
ADA X X |
IV Administration CLBR0012 |
SWI0192 X X X X X X X |
Adverse Events/Serious Adverse events(6) X X X X X X X X X X X X X X X X X X X X X X X X X X X X |
Chemistry, Hematology, and Urinalysis X X X X X X |
Prior and Concomitant Medications/ Nonpharmacologic therapies |
CTC |
Bone Marrow Biopsy(3) X |
Archival Bone Marrow Sample X |
Exploratory biomarkers4 X X X X X X X X |
1Assessment Cycle 2 - Patients will be treated on an Outpatient basis 2Assessment Cycle 1 - Patients will be admitted on Day 28 for evaluation and scheduled procedures, i.e. bone marrow biopsy |
CD19 Program timeline: |
Schedule 1.94: Corporate Names |
The Scripps Research Institute |
Scripps Research |
Calibr, a division of Scripps Research |
Calibr |
TSRI |
Schedule 1.119: Existing Patents |
[See attached.] |
Matters 70 items |
Client-Matter Cooley Docket Title Country Application Num Application Date Publication Num Publication Date Registration Num Registration Date Case Status Inventors Applicant TSRI Ref |
SWITCHABLE CAR-T THERAPIES FOR TREATING HUMAN CANCERS World Intellectual Property Organization PCT US22/081010 12/6/2022 WO 2023 107910 6/15/2023 Published Travis YOUNG, Eduardo LABORDA 2120.1PC |
SWITCHABLE CAR-T THERAPIES FOR TREATING HUMAN CANCERS United States 63/286,868 12/7/2021 Expired Travis YOUNG, Eduardo LABORDA 2120.0P |
NOVEL THERAPIES WITH ENGINEERED EFFECTOR CELLS World Intellectual Property Organization PCT US22/023791 7/2022 WO 2022 216906 10/13/2022 Published Travis YOUNG, Nelson Bruno 2081.1PC |
NOVEL CANCER THERAPIES WITH SWITCHABLE CAR-T PLATFORMS United States 63/172,212 8/2021 Abandoned Travis YOUNG, Nelson Bruno 2081.0P |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... United States 16/343,353 4/18/2019 20190359697 11/28/2019 11,174,306 11/16/2021 Issued Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1US |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... World Intellectual Property Organization PCT US17/057460 10/19/2017 WO 2018/075807 4/26/2018 Expired Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1PC |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... Republic of Korea 10-2019-0065433 5/17/2019 20200138985 12/11/2020 Published Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1KR |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... Japan 2022-153946 9/27/2022 2022-185016 12/13/2022 Published Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1JPD1 |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... Japan 2019-520888 10/19/2017 2019-535241 12/12/2019 7149935 9/29/2022 Issued Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1JP |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... Hong Kong 62020002300.5 10/19/2017 HK1291004 7/31/2020 Published Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1HK |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... European Patent Office 17794509.4 5/14/2019 3529268 8/28/2019 Published Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1EP |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... China 201780076966.5 6/12/2019 110267982 9/20/2019 Published Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1CN |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... Canada 3,040,343 10/19/2017 3040343 4/26/2018 Published Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1CA |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... United States 17/461,365 8/30/2021 20220073597 3/10/2022 Published Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1C1 |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... Australia 2017345479 10/19/2017 2017345479 5/9/2019 Published Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.1AU |
CHIMERIC ANTIGEN RECEPTOR EFFECTOR CELL SWITCHES WITH HUMANI... United States 62/410,315 10/19/2016 Expired Travis YOUNG, Leonard PRESTA, David RODGERS, Eric HAMPTON, Ti... 1924.0P |
OPTIMIZED PNE-BASED CHIMERIC RECEPTOR T CELL SWITCHES AND USES... United States 15/566,680 10/13/2017 20190169289 6/6/2019 11,091,546 8/17/2021 Issued Travis YOUNG, David RODGERS, Ian Hardy, Chanhyuk KIM, Peter G. S... 1923.2US |
OPTIMIZED PNE-BASED CHIMERIC RECEPTOR T CELL SWITCHES AND USES... World Intellectual Property Organization PCT US2016/027997 4/15/2016 WO 16/168773 10/20/2016 Expired Eric HAMPTON, Travis YOUNG, David RODGERS, Ian Hardy, Peter G... 1923.2PC |
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