Previously Treated CD20+ B-cell MalignanciesPhase 1NCT01858181

Phase I Study of Subcutaneous Ocaratuzumab in Patients With Previously Treated CD20+ B-Cell Malignancies

A Phase 1 study testing ocaratuzumab in people with Previously Treated CD20+ B-cell Malignancies, run by Mentrik Biotech, LLC at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity (ADCC) effector function. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Previously Treated CD20+ B-cell Malignancies
What is being tested?: ocaratuzumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Dec 2015
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 diagnosis of a CD20+ B-cell malignancy;
Received at least one prior treatment regimen;historically documented CD20-positivity is acceptable;
Appropriate for single agent study drug therapy as prescribed by this protocol;
ECOG performance status 0 to 2;
Adequate hematopoietic, renal, and hepatic functions defined as:

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Absolute neutrophil count greater than 1000 /mm³
Platelet count greater than 75,000/mm³
Hemoglobin greater than 8.5 g/dL
Serum creatinine ≤ 1.5x upper limit of normal
AST, ALT, and total bilirubin ≤ 3x upper limit of normal;
Ability to understand and the willingness to sign a written informed consent document;
Life expectancy of 6 months or greater.

Who cannot join

Anti-CD20 therapy within 4 weeks of enrollment;
Systemic chemotherapy or immunotherapy within 14 days of enrollment;
Chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or greater;
Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study;
Active infection, chronic or severe infection requiring ongoing antimicrobial therapy.
Positivity for hepatitis B (defined as HepBs Antigen +), hepatitis C (defined as HepC Antibody +), or HIV; HIV positive patients on antiretroviral therapy will be excluded;

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History of allergic reactions attributed to compounds of similar chemical or biologic composition;
Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication;
Women who are pregnant or breast-feeding;
Women of child bearing potential who are unwilling to use effective contraception for the duration of the study drug administration and 6 months after final dose of drug is administered;
Psychiatric illness/social situations that would limit compliance with study requirements;
Participation in other investigational studies while enrolled on this trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Universtity of Texas Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: A Phase I Study of Subcutaneous Ocaratuzumab (Fab- and Fc-engineered Anti-CD20 Monoclonal Antibody) in Patients With Previously Treated CD20+ B-Cell Malignancies

A previous phase I/II study of intravenously (IV) administered ocaratuzumab in refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and well-tolerated at doses up to 375mg/ m2 weekly for four weeks.

In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4 doses, 80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety, tolerability, pharmacokinetic, and pharmacodynamic analyses.

Conditions: Previously Treated CD20+ B-cell Malignancies
Being tested: ocaratuzumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ocaratuzumabBiological
Also called AME-133v, LY2469298

Study groups in NCT01858181
Study group	Role	What they receive
Cohort 1	Experimental	SC ocaratuzumab 40 mg weekly x 4 doses Receives: Biological: ocaratuzumab
Cohort 2	Experimental	SC ocaratuzumab 80 mg weekly x 4 doses Receives: Biological: ocaratuzumab
Cohort 3	Experimental	SC ocaratuzumab 80 mg weekly x 8 doses Receives: Biological: ocaratuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic parameters following SC ocaratuzumab administration such as area under the curve, maximum serum drug concentration, and elimination half life
Measured: Every office visit throughout the study for up to 12 months
Pharmacodynamic profile of B-cell depletion and re-population as measured by CD19+ peripheral blood B lymphocyte count
Measured: Baseline, day 1 and 8, 1 mon, 3 mon, 6 mon, and 12 mon post-treatment

Secondary outcomes (2)

Safety and tolerability of SC ocaratuzumab administration as described by the incidence of adverse events such as local injection site reactions or laboratory abnormalities
Measured: Every office visit throughout the study for up to 12 months
Immunogenicity as measured by the incidence, titre of human anti-human antibody (HAHA) immune response
Measured: Baseline, 1 mon, 2 mon, 3 mon, 6 mon, and 12 mon post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Dec 2015

First posted21 May 2013 (estimated)
Study startJan 2015
Primary completionDec 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Previously Treated CD20+ B-cell MalignanciesStudies 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
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01858181
Sponsor's protocol ID: MEN-001
Status last verified: Feb 2014
First submitted: 15 May 2013
Last updated: 3 Mar 2014
Results posted: No
Data monitoring committee: No

Publications

Forero-Torres A, de Vos S, Pohlman BL, Pashkevich M, Cronier DM, Dang NH, Carpenter SP, Allan BW, Nelson JG, Slapak CA, Smith MR, Link BK, Wooldridge JE, Ganjoo KN. Results of a phase 1 study of AME-133v (LY2469298), an Fc-engineered humanized monoclonal anti-CD20 antibody, in FcgammaRIIIa-genotyped patients with previously treated follicular lymphoma. Clin Cancer Res. 2012 Mar 1;18(5):1395-403. doi: 10.1158/1078-0432.CCR-11-0850. Epub 2012 Jan 5.
PubMed 22223529
Tobinai K, Ogura M, Kobayashi Y, Uchida T, Watanabe T, Oyama T, Maruyama D, Suzuki T, Mori M, Kasai M, Cronier D, Wooldridge JE, Koshiji M. Phase I study of LY2469298, an Fc-engineered humanized anti-CD20 antibody, in patients with relapsed or refractory follicular lymphoma. Cancer Sci. 2011 Feb;102(2):432-8. doi: 10.1111/j.1349-7006.2010.01809.x. Epub 2011 Jan 12.
PubMed 21205069

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study of Subcutaneous Ocaratuzumab (Fab- and Fc-engineered Anti-CD20 Monoclonal Antibody) in Patients With Previously Treated CD20+ B-Cell Malignancies
ClinicalTrials.gov ID: NCT01858181
Acronym / sponsor ID: MEN-001
Conditions: Previously Treated CD20+ B-cell Malignancies
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 9 participants (estimated)
Lead sponsor: Mentrik Biotech, LLCIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Dec 2015 (estimated)
First posted: 21 May 2013 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1	Experimental	Biological: ocaratuzumabSC ocaratuzumab 40 mg weekly x 4 doses
Cohort 2	Experimental	Biological: ocaratuzumabSC ocaratuzumab 80 mg weekly x 4 doses
Cohort 3	Experimental	Biological: ocaratuzumabSC ocaratuzumab 80 mg weekly x 8 doses

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Age >18 years;
Histologically confirmed diagnosis of a CD20+ B-cell malignancy;
Received at least one prior treatment regimen;historically documented CD20-positivity is acceptable;
Appropriate for single agent study drug therapy as prescribed by this protocol;
ECOG performance status 0 to 2;

Key exclusion criteria (12 listed)

Anti-CD20 therapy within 4 weeks of enrollment;
Systemic chemotherapy or immunotherapy within 14 days of enrollment;
Chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or greater;
Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study;
Active infection, chronic or severe infection requiring ongoing antimicrobial therapy.

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
ocaratuzumabAlso: AME-133v, LY2469298	Biological	Cohort 1, Cohort 2, Cohort 3

Primary outcome

Pharmacokinetic parameters following SC ocaratuzumab administration such as area under the curve, maximum serum drug concentration, and elimination half life
Time frame: Every office visit throughout the study for up to 12 months
Pharmacodynamic profile of B-cell depletion and re-population as measured by CD19+ peripheral blood B lymphocyte count
Time frame: Baseline, day 1 and 8, 1 mon, 3 mon, 6 mon, and 12 mon post-treatment

2 secondary outcomes

Safety and tolerability of SC ocaratuzumab administration as described by the incidence of adverse events such as local injection site reactions or laboratory abnormalities
Time frame: Every office visit throughout the study for up to 12 months
Immunogenicity as measured by the incidence, titre of human anti-human antibody (HAHA) immune response
Time frame: Baseline, 1 mon, 2 mon, 3 mon, 6 mon, and 12 mon post-treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
Background: PubMed 22223529Forero-Torres A, de Vos S, Pohlman BL, Pashkevich M, Cronier DM, Dang NH, Carpenter SP, Allan BW, Nelson JG, Slapak CA, Smith MR, Link BK, Wooldridge JE, Ganjoo KN. Results of a phase 1 study of AME-133v (LY2469298), an Fc-engineered humanized monoclonal anti-CD20 antibody, in FcgammaRIIIa-genotyped patients with previously treated follicular lymphoma. Clin Cancer Res. 2012 Mar 1;18(5):1395-403. doi: 10.1158/1078-0432.CCR-11-0850. Epub 2012 Jan 5.
Background: PubMed 21205069Tobinai K, Ogura M, Kobayashi Y, Uchida T, Watanabe T, Oyama T, Maruyama D, Suzuki T, Mori M, Kasai M, Cronier D, Wooldridge JE, Koshiji M. Phase I study of LY2469298, an Fc-engineered humanized anti-CD20 antibody, in patients with relapsed or refractory follicular lymphoma. Cancer Sci. 2011 Feb;102(2):432-8. doi: 10.1111/j.1349-7006.2010.01809.x. Epub 2011 Jan 12.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ocaratuzumab in people with Previously Treated CD20+ B-cell Malignancies, run by Mentrik Biotech, LLC at 1 site in United States.

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 13 inclusion and 12 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 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic parameters following SC ocaratuzumab administration such as area under the curve, maximum serum drug concentration, and elimination half life (time frame: Every office visit throughout the study for up to 12 months). 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?

On the ClinicalTrials.gov record for NCT01858181, which also lists 2 linked publications.

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 3 Mar 2014; AzTrials last refreshed its copy on 7 Nov 2026.