Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase I Study of Intravenous CHO-H01 in Patients With Refractory or Relapsed Follicular Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221348
Recruitment Status : Unknown
Verified January 2018 by Cho Pharma Inc..
Recruitment status was:  Not yet recruiting
First Posted : July 18, 2017
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Cho Pharma Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Follicular Lymphoma Biological: CHO-H01 Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Sequential Assignment
Intervention Model Description: 3+3 sequential cohort design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Open label treatment
Study drug (CHO-H01) administered on Day 1 of 28 day cycles up to 6 cycles total.
Biological: CHO-H01
Glyco-engineered anti-CD20 antibody




Primary Outcome Measures :
  1. 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

  2. Pharmacodynamic assessment of Immune cell activation [ Time Frame: 64 days ]
    Gene expression of immune cell activation following treatment compared to baseline


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: 8 weeks ]
    Lugano Revised Criteria for Response

  2. Serum drug concentration [ Time Frame: 72 hours ]
    Serum drug concentration measured at different times following drug administration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221348


Contacts
Layout table for location contacts
Contact: Thomas Dahl, PhD 617-818-2735 tadahl@outlook.com
Contact: Andrew Raubitschek, MD 626-321-1659 araubit@gmail.com

Sponsors and Collaborators
Cho Pharma Inc.
Investigators
Layout table for investigator information
Study Director: Thomas Dahl, PhD Sponsor GmbH
Layout table for additonal information
Responsible Party: Cho Pharma Inc.
ClinicalTrials.gov Identifier: NCT03221348    
Other Study ID Numbers: FOLHAT-001
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin