Clinical trial
A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL).
Name
CC-99282-NHL-001
Description
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.
Trial arms
Trial start
2019-05-20
Estimated PCD
2026-04-17
Trial end
2027-04-18
Status
Recruiting
Phase
Early phase I
Treatment
CC-99282
Specified dose on specified days
Arms:
Part A: Dose Escalation, Part B: Dose Expansion
Other names:
BMS-986369
Rituximab
Specified dose on specified days
Arms:
Part B: Dose Expansion
Obinutuzumab
Specified dose on specified days
Arms:
Part B: Dose Expansion
Tafasitamab
Specified dose on specified days
Arms:
Part B: Dose Expansion
Valemetostat
Specified dose on specified days
Arms:
Part B: Dose Expansion
Size
438
Primary endpoint
Incidence of Adverse Events (AEs)
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with laboratory abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with vital sign abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with electrocardiogram (ECG) abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with left ventricular ejection fraction (LVEF) assessment abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Number of participants with physical examination abnormalities
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Dose Limiting Toxicity (DLT)
Up to 28 days in Cycle 1
Maximum tolerated dose (MTD)
Up to 28 days in cycle 1
Eligibility criteria
Inclusion Criteria:
* History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria:
* Life expectancy ≤ 2 months
* Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter
* Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)
* Impaired cardiac function or clinically significant cardiac disease
Other protocol-defined inclusion/exclusion criteria apply
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 438, 'type': 'ESTIMATED'}}
Updated at
2024-04-04
1 organization
5 products
2 indications
Organization
CelgeneProduct
CC-99282Indication
lymphomaIndication
Non-HodgkinProduct
RituximabProduct
TafasitamabProduct
ObinutuzumabProduct
Valemetostat