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

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Macroglobulinemia and in IgM-MGUS Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia Perifosine in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia Randomised Trial in Waldenstrom’s Macroglobulinaemia A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom’s Macroglobulinemia (WM) Pomalidomide, Dexamethasone and Rituximab in Waldenstrom’s Macroglobulinemia Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Study of Epratuzumab (hLL2) in Patients With Waldenstrom’s Macroglobulinemia A Study for Patients That Have Been Previously Been Treated in Waldenstrom’s Macroglobulinemia or Multiple Myeloma Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

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

Official Title

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

Brief 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. 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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Adverse Events

Secondary Outcome

 Peak Plasma Concentration (Cmax)

Condition

Follicular Lymphoma

Intervention

PSB202

Study Arms / Comparison Groups

 Single-arm, escalating dose levels
Description:  3 + 3 Phase 1 dose escalation design; sequential ascending dose levels.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

110

Start Date

November 15, 2021

Completion Date

January 2024

Primary Completion Date

July 2023

Eligibility Criteria

        Inclusion Criteria:

        Phase 1a (dose escalation):

          1. Histologically confirmed CD20+ expressing indolent NHL (defined below), CLL or WM,
             failed or intolerant to standard of care therapies;

          2. 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.

          3. 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:

          4. 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.

          5. 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.

          6. Patients must have documented disease progression after at least two prior
             standard-of-care regimens.

          7. Patients must have measurable disease.

             All Patients:

          8. Signed Informed Consent;

          9. Eastern Cooperative Oncology Group (ECOG) 0-2

         10. Last dose of any anti-CD20 antibody therapy must have been >4 weeks before the first
             dose of PSB202

         11. 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.

         12. At least 18 years of age. There is no upper age restriction.

         13. 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.

         14. Adequate hematologic and coagulation status, defined as the following on C1D1 before
             treatment:

               1. 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.

               2. 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.

               3. 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.

               4. 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).

         15. Adequate hepatic function, defined as:

               1. ALT or AST ≤2.5 X the ULN or ≤5 X ULN with documented liver involvement.

               2. Total bilirubin ≤1.5 X ULN or ≤3 X ULN with documented liver involvement and/or
                  Gilbert's Disease

               3. Adequate renal function, with estimated glomerular filtration rate (eGFR) ≥50
                  mL/minute.

         16. Ability to comply with outpatient treatment, laboratory monitoring, and required
             clinic visits for the duration of study participation.

         17. 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.

             Exclusion Criteria

             Phase 1a (dose escalation) only:

         18. NHL with bulky disease defined as a mass ≥10 cm in longest diameter

         19. 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):

         20. Major surgery within 4 weeks prior to planned start of PSB202

         21. 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

         22. 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.

         23. 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.

         24. 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.

         25. 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.

         26. Active graft versus host disease (GVHD, including resultant from any prior solid organ
             transplants, if received), or ongoing immunosuppressive therapy.

         27. History of allogeneic stem cell transplant (allo-SCT) or allogeneic CAR-T at any time
             in the patient's medical history

         28. 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

         29. Active auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic
             thrombocytopenic purpura [ITP])

         30. 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.

         31. 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.

         32. 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

         33. 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.

         34. Pregnancy or lactation.

         35. 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.

         36. History of drug-induced liver injury or cirrhosis

         37. History of pneumonitis or interstitial lung disease

         38. 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.

             -
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lindsey E. Roeker, MD, 2069091125, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT05003141

Organization ID

PSB202-01


Responsible Party

Sponsor

Study Sponsor

Qilu Puget Sound Biotherapeutics (dba Sound Biologics)


Study Sponsor

Lindsey E. Roeker, MD, Study Chair, Memorial Sloan-Kettering Cancer Center, New York, NY


Verification Date

March 2022