Clinical trial · Interventional
Study of IV CBL0137 in Previously Treated Hematological Subjects
A Phase 1 Dose-Escalation and Cohort-Expansion Study of Intravenous CBL0137 in Subjects With Previously Treated Hematological Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reasons
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBL0137 | Drug | FACT Complex-targeting Curaxin CBL0137 | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CBL0137 Dose Escalation
- description
- * Dose 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
- interventionNames
- Drug: CBL0137
Primary outcomes (2)
- measure
- Part 1: Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 disease. * 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 years. * 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 diathesis. * 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.
References
Publications (0)
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