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

NCT05891821 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IMMONC0001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (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

  First dose to up to 27 months

Secondary Outcomes (11)

• Duration of Response (DOR)

  First dose to up to 27 months

• Disease Control Rate (DCR)

  First dose to up to 27 months

• Duration of Stable Disease (SD)

  First dose to up to 27 months

• Time to Response

  First dose to up to 27 months

• Progression-Free Survival (PFS) Time

  First dose to up to 27 months

Study Arms (1)

Balstilimab

EXPERIMENTAL

300 mg IV every 3 weeks for a maximum of 24 months

Drug: Balstilimab

Interventions

Balstilimab DRUG

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

Also known as: AGEN2034

Balstilimab

Eligibility Criteria

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

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• Has gone through disease progression after receiving prior therapy with:
• a. 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.

Sponsors & Collaborators

• Immune Oncology Research Institute: lead
• Agenus Inc.: collaborator

Study Sites (1)

Hematology Center named after prof. R. Yeolyan

Yerevan, 0014, Armenia

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

balstilimab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Gevorg Tamamyan, MD, PhD, DSc

  Immune Oncology Research Institute

  STUDY DIRECTOR

• Samvel Bardakhchyan, MD, PhD

  Immune Oncology Research Institute

  STUDY CHAIR

• Astghik Voskanyan, MD

  Hematology Center named after Prof. R. Yeolyan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Astghik Voskanyan, MD

CONTACT

+374 (10) 283800; astghikvos@gmail.com

Samvel Bardakhchyan, MD, PhD

CONTACT

+374 (10) 283800; bardakchyan-5samvel@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 7, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)