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LymphomaPhase 2NCT05891821

Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)

A Phase 2 study testing Balstilimab in people with Lymphoma, run by Immune Oncology Research Institute at 1 site in Armenia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this study is to see if the drug balstilimab is safe and effective in participants with relapsed/refractory lymphomas. Participants will receive balstilimab every 3 weeks and their outcomes will be assessed periodically. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Balstilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteArmenia
Study dates
1 Sep 2023to Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Voluntarily agree to participate by giving written informed consent
  • ≥ 18 years of age
  • Have a histologically confirmed diagnosis of a relapsed/refractory classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) for which no standard therapy is available or standard therapy has failed or the patient does not have access to it.
  • Has a life expectancy of at least 3 months and an ECOG performance status of ≤1 as determined by study Investigator
  • Patients must have sufficient and adequate formalin-fixed tumor tissue sample available that is not older than 3 years; otherwise, a fresh biopsy is required. Archival tissue or fresh biopsy must be from a site not previously irradiated
  • Has adequate organ function defined as the following laboratory values within 7 days of C1D1:
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  • Neutrophils ≥ 1500/μL (Must be stable and off any growth factor within 4 weeks of first study treatment administration)
  • Platelets ≥ 75 × 103/μL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)
  • Hemoglobin ≥ 8.0 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)
  • Creatinine clearance ≥ 30 mL/min as measured or calculated per local institutional standards
  • AST/ALT ≤ 3 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN)
  • Women of childbearing potential (WOCP) must have a negative serum pregnancy test at Screening (within 7 days before first dose of study drug). Non-childbearing potential is defined as (by other than medical reasons):
  • ≥ 50 years of age and has not menstruated for greater than 1 year
  • Whose status is post hysterectomy, bilateral oophorectomy, or tubal ligation
  • WOCP must be willing to use highly effective methods of contraception (defined in the informed consent form [ICF]) throughout the study, starting with the Screening Visit through 90 days after the last dose of study drug Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
  • Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
  • Is willing and able to comply with the requirements of the protocol

Who cannot join

  • Has an inadequate period of time prior to first dose of study treatment that is defined as:
  • Received systemic cytotoxic chemotherapy within 3 weeks before initiation of study treatment
  • Received biological therapy or investigational therapy within 4 weeks or 5 circulating halve-lives, whichever is shorter
  • Received small molecule/tyrosine kinase inhibitors within 2 weeks or 5 circulating half-lives, whichever is shorter
  • Received radiation therapy within 3 weeks before initiation of study treatment, except for palliative radiation therapy, which can be received 2 weeks prior to initiation of study treatment
  • Had major surgery within 4 weeks before initiation of study treatment
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  • Has gone through disease progression after receiving prior therapy with:
  • Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1 and anti-PD-L1 antibodies
  • Has persisting AEs related to prior immunotherapy of NCI-CTCAE v5.0 Grade ≥ 2 severity.
  • Is expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent, radiation therapy, and/or surgical resection)
  • Has known allergy or hypersensitivity to any component of balstilimab, any history of anaphylaxis, or uncontrolled asthma
  • Has active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Note: Patients with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible.
  • Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.
  • Has had an allogeneic tissue/solid organ transplant
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.
  • QTcF (QTc interval corrected using Fridericia's formula) of > 480 ms.
  • Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.
  • Has known untreated hepatitis B/hepatitis C virus (HBV/HCV) or tuberculosis. Active HBV is defined as a known positive hepatitis B surface antigen result. Active HCV is defined by a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay
  • Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.
  • Has other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and/or interpretation of the current study
  • Has known psychiatric or substance use disorders that would interfere with cooperation or compromise participation with the requirements of the study
  • Is legally incapacitated or has limited legal capacity
  • Is pregnant or breastfeeding
  • Has received a live/attenuated vaccine within 14 days of first dose of study treatment and other vaccines within 48 hours of first dose of study treatment
  • Has other co-morbidities that would alter risk-benefit of providing balstilimab (determined by treating physician's assessment)
  • Is receiving other therapy that would alter risk-benefit of providing balstilimab (determined by treating physician's assessment)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Astghik Voskanyan, MD contact

+374 (10) 283800

astghikvos@gmail.com

Samvel Bardakhchyan, MD, PhD contact

+374 (10) 283800

bardakchyan-5samvel@yandex.ru

Armenia1 site, 1 recruiting

  • Hematology Center named after prof. R. Yeolyan

    Yerevan, 0014

    Astghik Voskanyan, MD, +374 (010) 283800, astghikvos@gmail.com

    Recruiting

Other trials in Armenia

About this study

The goal of this study is to see if the drug balstilimab is safe and effective in participants with relapsed/refractory lymphomas.

Participants will receive balstilimab every 3 weeks and their outcomes will be assessed periodically.

Read the detailed description

This is a single-arm, open-label phase 2 study to evaluate the safety and efficacy of single agent balstilimab in participants with relapsed/refractory lymphoma. The study will enroll participants with relapsed/refractory classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma. The participants will receive balstilimab (BAL) 300 mg IV every 3 weeks. BAL infusions will be administered within 30 minutes (± 5 min) using an infusion pump.

The total estimated maximum time of study participation for each patient is approximately 49 months across 3 periods:

  • Screening Period: approximately 28 days
  • Treatment Period: up to 24 months, or until any criterion for stopping the study drug or withdrawal from the study occurs
  • Follow-up Period: up to 24 months from last dose of study treatment for every patient who is alive

Study Duration

  • Recruitment: 2 years
  • Treatment: 2 years
  • Follow-up: 2 years
Conditions
Lymphoma
Being tested
Balstilimab
Medical subject headings
Lymphoma

What participants receive

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

  • BalstilimabDrug

    Also called AGEN2034

    An anti-programmed death (ligand) 1 [PD-(L)1] monoclonal antibody

Study groups in NCT05891821
Study groupRoleWhat they receive
BalstilimabExperimental300 mg IV every 3 weeks for a maximum of 24 months
Receives: Drug: Balstilimab

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) assessed per the Lugano criteria

    Measured: First dose to up to 27 months

Secondary outcomes (11)

  1. Duration of Response (DOR)

    DOR is defined as time from first observation of response to first observation of documented disease progression per the Lugano criteria or death within 12 weeks of last tumor assessment

    Measured: First dose to up to 27 months

  2. Disease Control Rate (DCR)

    DCR is defined as the percentage of patients who have achieved complete response, partial response or stable disease per the Lugano criteria

    Measured: First dose to up to 27 months

  3. Duration of Stable Disease (SD)

    Duration of SD is measured from the start of treatment until the criteria for progression are met, per the Lugano criteria

    Measured: First dose to up to 27 months

  4. Time to Response

    Time to Response is defined as the time from the first dose date to first observation of confirmed response per the Lugano criteria

    Measured: First dose to up to 27 months

  5. Progression-Free Survival (PFS) Time

    PFS time is defined as time from first treatment administration to first observation of documented disease progression (or death within 12 weeks after last tumor assessment), per the Lugano criteria

    Measured: First dose to up to 27 months

  6. Overall Survival (OS) Time

    OS Time is defined as time from start of treatment to death

    Measured: First dose to up to 48 months

  7. Baseline expression of PD-L1 association with ORR

    Tumor PD-L1 status will be determined and correlation with ORR will be investigated

    Measured: First dose to up to 48 months

  8. Baseline expression of PD-L1 association with DOR

    Tumor PD-L1 status will be determined and correlation with DOR will be investigated

    Measured: First dose to up to 48 months

  9. Baseline expression of PD-L1 association with PFS

    Tumor PD-L1 status will be determined and correlation with PFS time will be investigated

    Measured: First dose to up to 48 months

  10. Baseline expression of PD-L1 association with OS

    Tumor PD-L1 status will be determined and correlation with OS time will be investigated

    Measured: First dose to up to 48 months

  11. Frequency, severity, and duration of treatment emergent adverse events (TEAEs) and laboratory abnormalities

    TEAEs are reported using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

    Measured: First dose to up to 27 months

Timeline

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

  1. First posted7 Jun 2023
  2. Study start1 Sep 2023
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05891821
Sponsor's protocol ID
IMMONC0001
Status last verified
Jun 2026
First submitted
11 May 2023
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Balstilimab in people with Lymphoma, run by Immune Oncology Research Institute at 1 site in Armenia.

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 18 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. 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 Armenia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Astghik Voskanyan, MD (+374 (10) 283800, astghikvos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: First dose to up to 27 months). 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 NCT05891821.

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 8 Jun 2026.

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