A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Titre officiel

A Phase 1B, Multicentre, Open-label Study to Determine the Safety, Pharmacokinetics and Preliminary Efficacy of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Sommaire:

L’étude CC-99282-CLL-001 est une étude clinique d’augmentation de la dose et d’expansion de phase I du CC-99282 administré en association avec l’obinutuzumab chez des sujets atteints d’une leucémie lymphoïde chronique/d’un petit lymphome lymphocytaire récidivant ou réfractaire.

Description de l'essai

Primary Outcome:

• Dose Limiting Toxicity (DLT)
• Maximum tolerated dose (MTD)
• Adverse Events (AEs)

Secondary Outcome:

• Pharmacokinetics - Cmax
• Pharmacokinetics - AUC
• Pharmacokinetics - Tmax
• Pharmacokinetics - t1/2
• Pharmacokinetics - CL/F
• Pharmacokinetics - V/F
• Objective response rate (ORR)
• Duration of response (DoR)
• Progression free survival
• Overall survival
• Complete response with incomplete marrow recovery (CRi)
• Nodular partial response (nPR)
• Partial response (PR)
• Partial response with lymphocytosis (PRL)

All eligible subjects must be relapsed or refractory to at least 2 prior lines of therapy, one of which must have included an inhibitor of B-cell receptor signaling (approved Bruton's tyrosine kinase inhibitor [BTKi] or Phosphoinositide 3-kinase inhibitor [PI3Ki]) or venetoclax. The dose escalation (Part A) will evaluate the safety, tolerability, and PK of escalating doses of CC-99282 given in combination with intravenous obinutuzumab to determine the MTD and RP2D of CC-99282 when given in combination with obinutuzumab.The dose expansion (Part B) may occur at the MTD established in the dose escalation phase, or at an alternative tolerable dosing schedule, based on review of safety, PK and PD data from Part A.

Voir cet essai sur ClinicalTrials.gov