Follicular LymphomaPhase 1NCT03221348
A Phase I Study of Intravenous CHO-H01 in Patients With Refractory or Relapsed Follicular Lymphoma
A Phase 1 study testing CHO-H01 in people with Follicular Lymphoma, run by Cho Pharma Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- CHO-H01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Follicular Lymphoma
- Being tested
- CHO-H01
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHO-H01Biological
Glyco-engineered anti-CD20 antibody
| Study group | Role | What they receive |
|---|---|---|
| Open label treatment | Experimental | Study drug (CHO-H01) administered on Day 1 of 28 day cycles up to 6 cycles total. Receives: Biological: CHO-H01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Pharmacodynamic assessment of Immune cell activation
Gene expression of immune cell activation following treatment compared to baseline
Measured: 64 days
Secondary outcomes (2)
Clinical response
Lugano Revised Criteria for Response
Measured: 8 weeks
Serum drug concentration
Serum drug concentration measured at different times following drug administration
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study startMar 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- 3+3 sequential cohort design
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cho Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Dahl, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221348
- Sponsor's protocol ID
- FOLHAT-001
- Status last verified
- Jan 2018
- First submitted
- 12 Jul 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03221348
- Acronym / sponsor ID
- FOLHAT-001
- Conditions
- Follicular Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cho Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 sequential cohort design
| Arm | Type | Receives |
|---|---|---|
| Open label treatment | Experimental | Biological: CHO-H01Study drug (CHO-H01) administered on Day 1 of 28 day cycles up to 6 cycles total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHO-H01Glyco-engineered anti-CD20 antibody | Biological | Open label treatment |
Primary outcome
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
Pharmacodynamic assessment of Immune cell activation
Time frame: 64 days
Gene expression of immune cell activation following treatment compared to baseline
2 secondary outcomes
Clinical response
Time frame: 8 weeks
Serum drug concentration
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Dahl, PhD study director
Sponsor GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHO-H01 in people with Follicular Lymphoma, run by Cho Pharma Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Dahl, PhD (617-818-2735, tadahl@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse drug reactions (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.