Clinical Trials /

Study of IV CBL0137 in Previously Treated Hematological Subjects



This clinical trial is a Phase 1, open-label, sequential-group, dose-escalation (Part 1) and cohort-expansion study (Part 2) evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of intravenously (IV) administered CBL0137 in participants with previously treated hematological malignancies.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Multiple Myeloma
  • Small Lymphocytic Leukemia
Recruiting Status:



Phase 1

Trial Eligibility



  • Brief Title: Study of IV CBL0137 in Previously Treated Hematological Subjects
  • Official Title: A Phase 1 Dose-Escalation and Cohort-Expansion Study of Intravenous CBL0137 in Subjects With Previously Treated Hematological Cancers

Clinical Trial IDs

  • ORG STUDY ID: I137-102
  • NCT ID: NCT02931110


  • Hematological Malignancies


CBL0137CuraxinCBL0137 Dose Escalation


This clinical trial is a Phase 1, open-label, sequential-group, dose-escalation (Part 1) and cohort-expansion study (Part 2) evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of intravenously (IV) administered CBL0137 in participants with previously treated hematological malignancies.

Detailed Description

      Part 1 of the study will evaluate the safety and pharmacology of a range of CBL0137 doses
      administered IV in participants with previously treated lymphomas, including diffuse large
      B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), Hodgkin
      lymphoma (HL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), or multiple
      myeloma (MM). Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively
      higher dose levels of CBL0137 using a standard 3+3 dose-escalation design. An additional 6
      participants may be accrued at the maximum tolerated dose (MTD) or at the recommended dose
      (RD) to confirm CBL0137 safety and pharmacology as a prelude to further clinical evaluation.

      Part 2 of the study provides cohort expansion to further explore the safety, pharmacology,
      and clinical activity of CBL0137 monotherapy in participants with specific previously treated
      hematological cancers, including DLBCL, FL, MCL, HL, CLL/SLL, acute lymphoblastic leukemia
      (ALL), acute myeloid leukemia (AML), and MM. Twelve evaluable participants with each disease
      type may be enrolled.

Trial Arms

CBL0137 Dose EscalationExperimentalDose Level 1: 150mg/m2, IV Dose Level 2: 180mg/m2, IV Dose Level 3: 240mg/m2, IV Dose Level 4: 320mg/m2, IV Dose Level 5: 400mg/m2, IV Dose Level 6: 540mg/m2, IV Dose Level 7: 650mg/m2, IV Dose Level 8: 780mg/m2, IV Dose Level 9: 950mg/m2, IV Dose Level 10: 1150mg/m2, IV Dose Level 11: 1400mg/m2, IV Dose Level 12: 1700mg/m2, IV Dose Level 13: 2000mg/m2, IV Dose Level 14: 2400mg/m2, IV Dose Level 15: 2900mg/m2, IV Dose Level 16: 3500mg/m2, IV
  • CBL0137

Eligibility Criteria

        Inclusion Criteria:

          -  Presence of an active hematological malignancy:

               -  Part 1 (Dose Escalation): Diagnosis of B-cell DLBCL, FL, MCL, HL, CLL/SLL, or MM
                  as documented by medical records.

               -  Part 2 (Cohort Expansion): Diagnosis of DLBCL, FL, MCL, HL, CLL/SLL, ALL, MM, or
                  AML as documented in medical records.

          -  Requirement for therapy of the hematological malignancy due to disease-related
             symptoms, lymphadenopathy, organomegaly, extranodal organ involvement, or progressive

          -  Hematological malignancy has been previously treated, has relapsed after or progressed
             during prior therapy, and has limited potential for benefit from currently available
             therapy, including hematopoietic stem cell transplantation.

          -  Presence of measurable disease:

               -  For subjects with DLBCL, FL, MCL, HL, or CLL/SLL: presence of radiographically
                  measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the
                  presence of ≥1 lesion that measures ≥2.0 cm in the longest dimension and ≥1.0 cm
                  in the longest perpendicular dimension as assessed by computed tomography).

               -  For subjects with MM, measurable disease with serum monoclonal immunoglobulin
                  protein (M-protein) ≥1 g/dL, or urine M-protein protein ≥200 mg/24 hours, or
                  involved serum free light chain ≥10 mg/dL.

               -  For subjects with ALL or AML, presence of >5% blasts in the bone marrow (based on
                  a bone marrow aspirate/biopsy sample with ≥200 nucleated cells and the presence
                  of bone marrow spicules) and/or >1 x 109/L blasts in the peripheral blood (with
                  the restriction that peripheral blast count in subjects with AML must be <50 x
                  109/L prior to the start of study therapy).

          -  Completion of all previous therapy (including surgery, radiotherapy, chemotherapy,
             immunotherapy, or investigational therapy) for the treatment of cancer ≥2 weeks before
             the start of study therapy. Note: For subjects with AML, the use of hydroxyurea for
             management of leukocytosis is allowed in Cycle 1 if hydroxyurea is started prior to
             the initiation of study therapy.

        Exclusion Criteria:

          -  Part 2 (Cohort Expansion): History of another malignancy except for the following:
             adequately treated local basal cell or squamous cell carcinoma of the skin; adequately
             treated carcinoma in situ without evidence of disease; adequately treated, papillary,
             noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in
             complete remission; or any other cancer that has been in complete remission for ≥2

          -  Rapidly progressive, clinically unstable central nervous system hematological
             malignancy. Note: Central nervous system evaluation is only required in subjects with
             known or suspected central nervous system malignancy.

          -  Significant cardiovascular disease, including myocardial infarction, arterial
             thromboembolism, or cerebrovascular thromboembolism, within 6 months prior to start of
             study therapy; symptomatic dysrhythmias or unstable dysrhythmias requiring medical
             therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York
             Heart Association Class 3 or 4 congestive heart failure; uncontrolled Grade ≥3
             hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg)
             despite antihypertensive therapy; or history of congenital prolonged QT syndrome.

          -  Significant screening ECG abnormalities, including unstable cardiac arrhythmia
             requiring medication, atrial fibrillation/flutter, left bundle-branch block,
             2nd-degree atrioventricular (AV) block type II, 3rd degree AV block, Grade ≥2
             bradycardia, or QT corrected for heart rate (QTc) >450 msec (for men) or >470 msec
             (for women).

          -  Ongoing risk for bleeding due to active gastrointestinal disease or bleeding

          -  Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper
             respiratory tract infections) at the time of start of study therapy. Note: Subjects
             with localized fungal infections of skin or nails are eligible.

          -  In subjects with prior progenitor cell transplantation, evidence of ongoing
             graft-versus-host disease.

        Please speak with Investigator for the complete Inclusion/Exclusion criteria.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1: Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
Time Frame:At the end of Cycle 1 (each cycle is 21 days)
Safety Issue:
Description:MTD is defined as dose level at which ≥6 subjects have been treated and which is associated with a first-cycle dose-limiting toxicity (DLT) in ≤17% of the participants. RD may be the MTD or may be a lower dose within the tolerable dose range. Selection of the RD will be based on consideration of short- and long-term safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data.


Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Incuron

Trial Keywords

  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma (FL)
  • Mantle cell lymphoma (MCL)
  • Hodgkin lymphoma (HL)
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma
  • Multiple myeloma (MM)
  • Acute lymphoblastic leukemia (ALL)
  • Acute myeloid leukemia (AML)

Last Updated

December 10, 2020