- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221348
A Phase I Study of Intravenous CHO-H01 in Patients With Refractory or Relapsed Follicular Lymphoma
A Phase I Open-label, Multiple Dose Study of CHO-H01 Administered Intravenously as a Single Agent to Subjects With Refractory or Relapsed Follicular Lymphoma
This is a single-arm open label trial to explore the tolerability, safety, PK, PD, and anti-tumor activity of various doses and schedules of CHO-H01 administered as monotherapy in subjects with follicular lymphoma.
Groups of 6 subjects are planned for each cohort. The first 3 patients of each cohort will be evaluated to determine if it is appropriate to proceed with the additional 3 patients at that dose and schedule.
Study Overview
Detailed Description
This is a single-arm open label trial to explore the tolerability, safety, PK, PD, and anti-tumor activity of various doses and schedules of CHO-H01 administered as monotherapy in subjects with follicular lymphoma. This is not an MTD study, but an evaluation of optimum biological activity.
Groups of 6 subjects are planned for each cohort. The first 3 patients of each cohort will be evaluated to determine if it is appropriate to proceed with the additional 3 patients at that dose and schedule.
Schema 1:
1 mg/kg administered on D1 of Cycle 1 and D1 of subsequent 28 day cycles. Up to 6 cycles total are planned per subject.
Schema 2-3 Details to be determined after analysis of first 3-6 patients treated on Schema 1. Doses may be either escalated or de-escalated, or modified for Cycles 2-6 relative to Cycle 1. Schedules to be explored could include multiple doses with the first cycle: D1, D8 of 28 day cycles and D1, D8, D15 of 28 days cycles. In no case will individual doses exceed 10mg/kg.
Decisions on whether to proceed with a schema and details of selected dose and schedule will be made during cohort data review meetings by a Clinical-Scientific Review Team (CSRT) comprised of the trial investigators and Medical/Clinical and Safety representatives from the Sponsor. Ad hoc members will be consulted as needed.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Thomas Dahl, PhD
- Phone Number: 617-818-2735
- Email: tadahl@outlook.com
Study Contact Backup
- Name: Andrew Raubitschek, MD
- Phone Number: 626-321-1659
- Email: araubit@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 years Histologically confirmed, measurable, CD20 positive Follicular B cell lymphoma with an indication for treatment for which there is no therapy of curative potential or of higher priority
- Life expectancy of greater than 1 year
- ECOG performance status of 0 to 1
- Last dose of prior anti-cancer therapy must be at least 56 days (or two half-lives for proteins, whichever is greater) prior to the first administration of the study drug (to satisfy the recognized requirement of at least 5 times the terminal half-life period for most drugs currently used, including most receptor tyrosine kinase (RTK) inhibitors).
- Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 0 or 1.
- Subject must be willing and able to provide fresh tumor at Screening. Subjects will be asked to provide additional needle biopsy samples on C2D8 and C4D8. Archival tumor biopsy (i.e., tissue block or series of ≈10 slides) is requested if available, and should be provided during the Screening period.
- Local laboratories may be used for standard laboratory assessments:
Adequate bone marrow function defined by: absolute neutrophil count (ANC) of ≥ 1.5 x 109/L, platelet count of ≥ 100.0 x 109/L, and hemoglobin ≥9.0 g/dL.
Adequate hepatic function defined by: serum total bilirubin < 2 mg/dl (unless resulting from hemolysis), aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 x ULN (or ≤ 5 x ULN in subjects with liver metastases).
Adequate renal function assessed by: serum creatinine within normal limits, or creatinine clearance (by Cockcroft Gault formula) ≥ 50 mL/min for subjects in whom serum creatinine may not adequately reflect renal function.
- Must have measurable disease as described in Lugano Revised Criteria for Response. This assessment is the responsibility of the investigator who may use local radiology to support this assessment.
- Willing and able to understand and sign an informed consent form and to comply with all aspects of the protocol.
- Willingness to use effective methods of contraception.
- Adequate T cell immune parameters - CD4 >500/mcL, CD8 > 250/mcL
- Bone marrow biopsy revealing adequate hematologic reserves
Exclusion Criteria:
- Evidence of circulating tumor cells >500 cells/microliter of lymphocytes or equivalent
- History of allergic reactions to any component of the study drug
- Autoimmune disease (Exceptions: autoimmune thyroiditis)
- Concomitant use of systemic corticosteroids
- History of seizure disorder
- History of Central Nervous System (CNS) metastases or seizure disorder related to the malignancy.
- History of symptomatic congestive heart failure (CHF), unstable angina pectoris, unstable atrial fibrillation; cardiac arrhythmia
- Non-manageable electrolyte imbalances, including hypokalemia, hypocalcemia, hypomagnesemia, and hypomagnesemia, of Grade 2 or greater (NCI-CTCAE v. 4.0)
- Any uncontrolled intercurrent illness, infection, or other condition that could limit study compliance or interfere with assessments
- Pregnancy or breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open label treatment
Study drug (CHO-H01) administered on Day 1 of 28 day cycles up to 6 cycles total.
|
Glyco-engineered anti-CD20 antibody
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse drug reactions
Time Frame: 28 days
|
Treatment-emergent adverse events and clinically significant laboratory values assessed for each subject and aggregated by type, frequency and severity by treatment cohort
|
28 days
|
Pharmacodynamic assessment of Immune cell activation
Time Frame: 64 days
|
Gene expression of immune cell activation following treatment compared to baseline
|
64 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response
Time Frame: 8 weeks
|
Lugano Revised Criteria for Response
|
8 weeks
|
Serum drug concentration
Time Frame: 72 hours
|
Serum drug concentration measured at different times following drug administration
|
72 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thomas Dahl, PhD, Sponsor GmbH
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FOLHAT-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Follicular Lymphoma
-
Joseph TuscanoNational Cancer Institute (NCI); Genentech, Inc.; Pharmacyclics LLC.RecruitingAnn Arbor Stage II Follicular Lymphoma | Ann Arbor Stage III Follicular Lymphoma | Ann Arbor Stage IV Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular LymphomaUnited States
-
National Cancer Institute (NCI)TerminatedStage III Grade 1 Follicular Lymphoma | Stage III Grade 2 Follicular Lymphoma | Stage III Grade 3 Follicular Lymphoma | Stage IV Grade 1 Follicular Lymphoma | Stage IV Grade 2 Follicular Lymphoma | Stage IV Grade 3 Follicular LymphomaUnited States
-
National Cancer Institute (NCI)RecruitingRecurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular LymphomaUnited States
-
Memorial Sloan Kettering Cancer CenterFox Chase Cancer Center; Pharmacyclics LLC.TerminatedFollicular Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma, Grade 2 | Follicular Lymphoma Grade IIIaUnited States
-
Robert LowskyNational Cancer Institute (NCI); Janssen, LP; The Leukemia and Lymphoma Society; Rising Tide FoundationCompletedMantle Cell Lymphoma | Marginal Zone Lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular LymphomaUnited States
-
Olivia Newton-John Cancer Research InstituteBristol-Myers Squibb; Barwon Health; Austin Health; Eastern Health; Fiona Stanley... and other collaboratorsRecruitingFollicular Lymphoma Stage II | Follicular Lymphoma Stage III | Follicular Lymphoma Stage IVAustralia
-
Fondazione Italiana Linfomi ONLUSCompletedFollicular Lymphoma, Grade 1 | Follicular Lymphoma, Grade 2 | Follicular Lymphoma Grade 3AItaly
-
Massachusetts General HospitalTG TherapeuticsActive, not recruitingLymphoma | Follicular Lymphoma | Marginal Zone Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma Grade IIIa | Marginal Zone B Cell Lymphoma | Follicular Lymphoma Grade 2United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGrade 3a Follicular Lymphoma | Ann Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage III Grade 3 Follicular Lymphoma | Ann Arbor Stage...United States
-
National Cancer Institute (NCI)Celgene CorporationActive, not recruitingAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
Clinical Trials on CHO-H01
-
Cho Pharma Inc.RecruitingNon-Hodgkin LymphomaTaiwan, United States
-
Wageningen UniversityRecruiting
-
Stanford UniversityCompletedPulmonary HypertensionUnited States
-
Per Bendix JeppesenFuture Food InnovationCompletedAthletic PerformanceDenmark
-
University of AarhusInnovation Fund DenmarkRecruitingAthletic PerformanceDenmark
-
The University of Tennessee, KnoxvilleCompletedSupplementation During Endurance PerformanceUnited States
-
Erica GoldsteinCompletedDietary SupplementationsUnited States
-
Abbott NutritionNot yet recruitingDiabetes type2