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

NCT03221348 | Unknown Phase 1 FDA Drug

• 1 other identifier: FOLHAT-001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (2)

• Adverse drug reactions

  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

  Gene expression of immune cell activation following treatment compared to baseline

  64 days

Secondary Outcomes (2)

• Clinical response

  8 weeks

• Serum drug concentration

  72 hours

Study Arms (1)

Open label treatment

EXPERIMENTAL

Study drug (CHO-H01) administered on Day 1 of 28 day cycles up to 6 cycles total.

Biological: CHO-H01

Interventions

CHO-H01 BIOLOGICAL

Glyco-engineered anti-CD20 antibody

Open label treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cho Pharma Inc.: lead

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Thomas Dahl, PhD

  Sponsor GmbH

  STUDY DIRECTOR

Central Study Contacts

Thomas Dahl, PhD

CONTACT

617-818-2735; tadahl@outlook.com

Andrew Raubitschek, MD

CONTACT

626-321-1659; araubit@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 sequential cohort design

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 18, 2017
• Study Start: March 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share