Chronic Lymphocytic Leukemia (CLL) Clinical Trial
Official title:
A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies
This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.
Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-5948 in adult patients with relapsed/refractory (R/R) B cell malignancies who have received at least 2 prior lines of therapy, or at least 1 prior line of therapy for Primary Central Nervous System Lymphoma (PCNSL), and for whom no other therapies are known to provide clinical benefit. Indications include: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), Waldenstrom Macroglobulinemia (WM), Marginal Zone Lymphoma (MZL), Follicular Lymphoma (FL), or Primary Central Nervous System Lymphoma (PCNSL). Phase 1b will investigate the efficacy of NX-5948 at the dose(s) selected in Phase 1a in up to 7 expansion arms of patients with histologically confirmed R/R B-cell malignancy indications who have received the specified prior therapies based on indication: - CLL or SLL (two dose levels will be investigated for CLL/SLL) - MCL - MZL - WM - DLBCL - FL - PCNSL/SCNSL ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03588598 -
Safety, Tolerability, and Pharmacokinetics of SHC014748M in Patients With Indolent B-Cell Hematologic Malignancies
|
Phase 1 | |
| Recruiting |
NCT06043011 -
Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
|
||
| Completed |
NCT02265731 -
Study Evaluating Venetoclax in Subjects With Hematological Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT02582879 -
informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
|
||
| Completed |
NCT02553304 -
Molecular Features Underlying Racial Differences in Survival of Taiwanese Chronic Lymphocytic Leukemia Patients
|
||
| Completed |
NCT01419691 -
Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)
|
Phase 2 | |
| Completed |
NCT01188681 -
Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04758975 -
Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL)
|
Phase 2 | |
| Terminated |
NCT02914938 -
A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma
|
Phase 1 | |
| Active, not recruiting |
NCT01976520 -
Vaccine Therapy for Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
|
Phase 1 | |
| Terminated |
NCT01463852 -
A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)
|
Phase 0 | |
| Terminated |
NCT01203930 -
A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL
|
Phase 2 | |
| Recruiting |
NCT02966756 -
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
|
Phase 2 | |
| Active, not recruiting |
NCT05105841 -
Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
|
Phase 2 | |
| Recruiting |
NCT04072458 -
A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies
|
Phase 1 | |
| Withdrawn |
NCT01754870 -
Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy Followed by Maintenance Rituximab (Rituxan®) and Lenalidomide (Revlimid®) in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
|
Phase 2 | |
| Recruiting |
NCT01758042 -
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
| Completed |
NCT01885897 -
IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04830137 -
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
|
Phase 1 | |
| Recruiting |
NCT03547115 -
A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML
|
Phase 1 |