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Follicular LymphomaPhase 1NCT05003141

PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies

A Phase 1 study testing PSB202 in people with Follicular Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Qilu Puget Sound Biotherapeutics (dba Sound Biologics) at 5 sites in 3 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

Product: PSB202 is a novel biological entity consisting of two engineered monoclonal antibodies, an Fc-enhanced humanized type II anti-CD20 IgG1 (PSB102) and a humanized anti-CD37 IgG1 (PSB107), that target B-cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PSB202
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
5 sitesin 3 countries
Study dates
15 Nov 2021to Jan 2024
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

  • Phase 1a (dose escalation):
  • Histologically confirmed CD20+ expressing indolent NHL (defined below), CLL or WM, failed or intolerant to standard of care therapies;
  • Relapsed/refractory following at least 2 prior lines of standard of care treatment. Prior treatments received must be documented on the enrollment request form. For FL, prior treatment must have included at least 1 rituximab containing regimen.
  • First three dose levels: in the opinion of the investigator, able to tolerate potentially subtherapeutic doses of PSB202 for the duration of a 28-day DLT observation window.
  • Phase 1b - Dose Expansion:
  • Histologically confirmed CD20+ expression. For CD37+, if unavailable from the chart at screening, CD37+ expression may be documented from a new or archived blood specimen after enrollment.
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  • Relapsed indolent NHL: histologies that may be included are CLL/SLL, MZL, MALT-lymphoma, follicular NHL, MCL or WM failed, relapsed/refractory or intolerant to at least 2 standard of care therapies. (APPENDIX B). For FL, prior treatment must have included rituximab. MCL must have received a prior alkylating agent.
  • Patients must have documented disease progression after at least two prior standard-of-care regimens.
  • Patients must have measurable disease.
  • All Patients:
  • Signed Informed Consent;
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Last dose of any anti-CD20 antibody therapy must have been >4 weeks before the first dose of PSB202
  • Patients with a medical history of Covid-19 positivity at within 6 months prior to enrollment, must be retested within 7 days of enrollment and confirm Covid-19 negativity by a PCR-test.
  • At least 18 years of age. There is no upper age restriction.
  • Four weeks wash-out from any other prior cancer therapy, including rituximab or BTK-inhibitors. However, some heavily pretreated patients are at risk for significant morbidity from accelerated disease progression or "flare" when treatment is discontinued prior to the initiation of subsequent effective therapy. Absent residual toxicity and with documented Medical Monitor approval, such patients may receive study drug after five drug half-lives have passed following discontinuation of the immediate pre-study therapy.
  • Adequate hematologic and coagulation status, defined as the following on C1D1 before treatment:
  • Absolute neutrophil count (ANC) ≥ 0.75 billion/L; not requiring growth factors; after the DLT period, growth factor support is allowed and considered supportive care.
  • Platelet count ≥75 billion/L not requiring transfusion support; if there is documented bone marrow involvement, platelet transfusions may be used up to 7 days prior to C1D1 to achieve this threshold.
  • Hemoglobin (Hb) ≥9 mg/dL not requiring transfusion support or growth factors. After the DLT period, growth factor support is allowed and considered supportive care.
  • Adequate coagulation, defined as aPTT and PT (INR) not greater than 1.5 × upper limit of normal (ULN) (patients appropriately anticoagulated for a preexisting medical condition [e.g., atrial fibrillation] may be eligible with documented Sponsor approval).
  • Adequate hepatic function, defined as:
  • ALT or AST ≤2.5 X the ULN or ≤5 X ULN with documented liver involvement.
  • Total bilirubin ≤1.5 X ULN or ≤3 X ULN with documented liver involvement and/or Gilbert's Disease
  • Adequate renal function, with estimated glomerular filtration rate (eGFR) ≥50 mL/minute.
  • Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
  • Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment; this may include barrier methods such as condom or diaphragm with spermicidal gel.

Who cannot join

  • Phase 1a (dose escalation) only:
  • NHL with bulky disease defined as a mass ≥10 cm in longest diameter
  • Transformation (e.g., Richter's transformation, prolymphocytic leukemia, transformed NHL, blastoid lymphoma) prior to planned start of PSB202. In addition, no concurrent investigational therapy is permitted.
  • All patients: Phase 1a (dose escalation) and Phase 1b (dose expansion):
  • Major surgery within 4 weeks prior to planned start of PSB202
  • Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment, except for patients receiving radiation to more than 30% of the bone marrow or receiving whole brain radiotherapy, which must be completed at least 4 weeks prior to the first dose of study treatment
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  • Continuation of certain standard of care anticancer therapies, including hormonal therapy for breast and prostate cancer, and growth factor support after completion of the DLT-period, is allowed.
  • Therapeutic monoclonal antibody treatment must be discontinued a minimum of 4 weeks prior to the first dose of PSB202. PSB202 may be started sooner after prior investigational agent or anticancer therapy if considered by the Investigator to be safe and within the best interest of the patient (e.g., to avoid disease flare) and with documented Sponsor approval.
  • Any unresolved toxicities from prior therapy greater than CTCAE (version 5.0) Grade 2 or greater at the time of starting study treatment except for alopecia.
  • History of autologous stem cell transplant (auto-SCT) or chimeric antigen receptor-modified T cell (CAR-T) therapy within the past 180 days with any of the following: cytopenias from incomplete blood cell count recovery post-transplant, need for anti-cytokine therapy, residual symptoms of neurotoxicity > Grade 1, or ongoing immunosuppressive therapy.
  • Active graft versus host disease (GVHD, including resultant from any prior solid organ transplants, if received), or ongoing immunosuppressive therapy.
  • History of allogeneic stem cell transplant (allo-SCT) or allogeneic CAR-T at any time in the patient's medical history
  • Known central nervous system (CNS) involvement by lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS-disease may be eligible if a clinical rationale is provided by the Investigator and with documented Sponsor approval
  • Active auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
  • Cerebrovascular accident (CVA), Transient ischemic attack (TIA), myocardial infarction, unstable angina, or New York Heart Association (NYHA) class III or IV heart failure < 6 months of study screening; mean ECG QT-interval corrected according to Fridericia's formula (QTcF) > 450 milliseconds (ms) (males) or > 470 ms (females) obtained from three ECGs; uncontrolled arrhythmia < 3 months of study screening. Patients with rate-controlled arrhythmias may be eligible for study entry at discretion of the Investigator.
  • Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the Investigator and the Sponsor makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required.
  • Tested positive for Human Immunodeficiency Virus (HIV) is excluded (due to potential drug-drug interactions between anti-retroviral medications and PSB202 and risk of opportunistic infections). For patients with unknown HIV status, HIV testing will be performed at Screening
  • Active viral hepatitis (B or C, HBsAg, anti-HBs/HBcAb and anti-HCV Ab tests) as demonstrated by positive serology or requiring treatment. Subjects who are anti-HBs/HBcAb (+) without detectable HBV-DNA are eligible. Subjects with a history of Hepatitis C and have received successful curative treatment are eligible.
  • Pregnancy or lactation.
  • Active autoimmune disease or history of autoimmune disease requiring systemic therapy < 2 years prior to screening except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes. Patients with childhood asthma or atopy that has not been active in the 2 years prior to study screening are eligible.
  • History of drug-induced liver injury or cirrhosis
  • History of pneumonitis or interstitial lung disease
  • Patients with significant medical diseases or conditions, as assessed by the Investigator and Sponsor, that would substantially increase the risk-benefit ratio of participating in the study.
  • -

Trial locations and contacts

5 sites in 3 countries.

Jelle W. Kijlstra, MD contact

2069091125

jelle@soundbiologics.com

Joan Sun contact

8622132588

joan.sun@qilu-pharma.com

5 sites in 3 countries

United States2 sites, 2 recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

    Don Stevens, MD

    Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

    Lindsey E Roeker, MD

    Not yet recruiting

Other trials in United States

Australia2 sites, 2 recruiting

  • Epworth Healthcare

    East Melbourne, Victoria, 3002

    Yannacou Costas, MD

    Recruiting

  • One Clinical research

    Perth, Western Australia, 6153

    Peter Tan, MD

    Recruiting

Other trials in Australia

China1 site, 1 recruiting

  • Ruijin Hospital

    Shanghai

    Wei-Li Zhao, MD, PhD, Zhao.Weili@yahoo.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1a/1b Study of PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies

Product: PSB202 is a novel biological entity consisting of two engineered monoclonal antibodies, an Fc-enhanced humanized type II anti-CD20 IgG1 (PSB102) and a humanized anti-CD37 IgG1 (PSB107), that target B-cells. PSB202 is manufactured to work as a single product with the two components of PSB202 enabling a distinct dual target-specific antibody directed cell killing of B-cells.

Study: Multi-center-, International Phase 1a/1b (Escalation/Expansion) study in patients with indolent-, relapsed-, B-cell malignancies. The Phase 1a (Dose Escalation) part of study follows a 3+3 design.

Read the detailed description

Product: PSB202 is a novel biological entity consisting of two engineered monoclonal antibodies, an Fc-enhanced humanized type II anti-CD20 IgG1 (PSB102) and a humanized anti-CD37 IgG1 (PSB107), that target B-cells. PSB202 is manufactured to work as a single product with the two components of PSB202 enabling a distinct dual target-specific antibody directed cell killing of B-cells.

Study: Multi-center-, International Phase 1a/1b (Escalation/Expansion) study in patients with indolent-, relapsed-, CD20+ and CD37+ expressing B-cell malignancies. Phase 1a (Dose Escalation) portion of study follows 3+3 design. Phase 1b (Expansion) enrolls with up to 20 patients in each one of 3 disease-specific cohorts: (1) FL; (2) CLL/SLL, and (3) a mixed indolent B-cell histology cohort comprising WM, indolent phenotype MCL, and MZL.

Primary objectives for Phase 1a are Safety (DLT) and establishing a recommended Phase 1b dose. Primary objective for Phase 1b is establishing preliminary evidence of an anti-lymphoma response in each of the 3 Expansion cohorts, as determined by ORR.

Being tested
PSB202
Keywords
Phase 1, CD20+, CD37+, B-cell malignancy, B-cell lymphoma, monoclonal antibody
Medical subject headings
Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Lymphoma, B-Cell

What participants receive

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

  • PSB202Drug

    PSB202 is an antibody combination product comprised of two full-length monoclonal antibodies, PSB102 and PSB 107, respectively targeting CD20 and CD37. PSB202 is manufactured to work as a single product.

Study groups in NCT05003141
Study groupRoleWhat they receive
Single-arm, escalating dose levelsExperimental3 + 3 Phase 1 dose escalation design; sequential ascending dose levels.
Receives: Drug: PSB202

What is being measured

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

  1. Adverse Events

    Adverse Events, defined and graded per NCI Common Toxicity criteria (V5)

    Measured: Through study completion; up to 27 weeks

  2. Dose Limiting Toxicity (DLT)

    Defined Grade 3, Grade 4, and Grade 5 events occurring during the DLT-observation period

    Measured: 3 weeks

Secondary outcomes (4)

  1. Peak Plasma Concentration (Cmax)

    Cmax for each of the two antibody components of PSB202 (PSB102 and PSB107)

    Measured: 2 months

  2. Area under the Plasma Concentration versus Time Curve (AUC)

    AUC for each of the two antibody components of PSB202 (PSB102 and PSB107)

    Measured: 2 months

  3. Number of Patients with measurable Anti-Lymphoma Response

    International Working Group Criteria (Lugano) for NHL; Hallek Criteria for CLL

    Measured: Up to 27 weeks

  4. Change in CD20+ cell counts

    Surrogate Pharmacodynamic marker: Change in CD20+ cell counts by flow cytometry

    Measured: 2 months

Timeline

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

  1. First posted12 Aug 2021
  2. Study start15 Nov 2021
  3. Primary completionJul 2023 (estimated)
  4. Study completionJan 2024 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Phase 1a: 3+3 dose escalation design Phase 1b: 3 Expansion cohorts (N=20 each). Expansion beyond N=20 in a cohort is predicated on an ORR of at least 35% (Futility threshold) observed in the initial N=20 in the cohort.
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003141
Sponsor's protocol ID
PSB202-01
Status last verified
Mar 2022
First submitted
20 Jul 2021
Last updated
28 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wang L, Liu J, Zhou K, Li Z, Zeng Y, Qian Y, Sun Y, Wu H, Roerker L, Tan P, Ma C, Zhou L, Duan X, Kang X, Zhao WL. A first-in-class bifunctional antibody targeting CD20 and CD37 remodels the immune microenvironment in relapsed or refractory B-cell malignancies. J Hematol Oncol. 2026 May 29;19(1):36. doi: 10.1186/s13045-026-01796-5.

    PubMed 42216090

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PSB202 in people with Follicular Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Qilu Puget Sound Biotherapeutics (dba Sound Biologics) at 5 sites in 3 countries.

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 27 inclusion and 24 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 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Australia, China. 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?

Contact Jelle W. Kijlstra, MD (2069091125, jelle@soundbiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Through study completion; up to 27 weeks). 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 NCT05003141, which also lists 1 linked publication.

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 28 Mar 2022.

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