Clinical trial · Interventional
Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Study of Safety, Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM). The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety and tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicle Centre Lymphoma Diffuse | Follicular Lymphoma with Predominantly Diffuse Growth Pattern | ALIAS | 0.90 |
| Mantle Zone Lymphoma Refractory/Recurrent | — | UNRESOLVED | — |
| Relapsed or Refractory B Cell Non-Hodgkin Lymphoma | — | UNRESOLVED | — |
| Waldenstrom's Macroglobulinemia | Waldenstrom Macroglobulinemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-1530 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CT-1530
- interventionNames
- Drug: CT-1530
Primary outcomes (1)
- measure
- Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
- timeFrame
- 28 days
- description
- Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-1530 in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Mental-cell lymphoma, Diffuse large B-cell lymphoma, FL and Waldenstrom's Macroglobulinemia
Secondary outcomes (3)
- measure
- Overall Response Rate (ORR) - Phase I
- timeFrame
- Up to 24 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of B cell Non-Hodgkin Lymphoma(according to World Health Organization \[WHO\] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop). * Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment. * Eastern Cooperative Oncology Group performance status of ≤ 1 and a life expectancy of at least 3 months. * Measurable disease as per RECIST v1.1 * Availability of tumor sample * Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10\^9/L and platelets ≥ 50 x 10\^9/L; patients with neutrophils \< 1.0 x 10\^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10\^9/L. * Adequate renal function, as defined by creatinine clearance of ≥ 50 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection). * Adequate liver function, as defined by AST and ALT ≤ 3 x ULN, and bilirubin ≤ 1.5 x ULN (unless documented Gilbert's syndrome). Exclusion Criteria: * Prior allogeneic bone marrow transplant * Autologous stem cell transplant within 3 months of screening * Active central nervous system involvement * Subjects with autoimmune hemolytic anemia or immune thrombocytopenia * Prior treatment with a Btk inhibitor * Active uncontrolled infection * History of malabsorption * Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc. * History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months * History of another currently active cancer * History of major surgery within 4 weeks or minor surgery within 1 week * Other medical or psychiatric illness or organ dysfunction * HIV positive * Positive for Hepatitis B surface antigen or Hepatitis C-virus Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available