Clinical trial
A Phase 1B, Multicenter, 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
Name
CC-99282-CLL-001
Description
CC-99282-CLL-001 study is a Phase IB dose escalation and expansion clinical study of CC-99282 administered in combination with Obinutuzumab in subjects with relapsed or refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Trial arms
Trial start
2020-12-21
Estimated PCD
2024-11-15
Trial end
2025-05-13
Status
Active (not recruiting)
Phase
Early phase I
Treatment
CC-99282
CC-99282
Arms:
CC-99282 + obinutuzumab
Obinutuzumab
Obinutuzumab
Arms:
CC-99282 + obinutuzumab
Size
50
Primary endpoint
Dose Limiting Toxicity (DLT)
Up to Cycle 2 Day 14 (each cycle is 28 days)
Maximum tolerated dose (MTD)
Up to Cycle 2 Day 14 (each cycle is 28 days
Adverse Events (AEs)
From first subjects first visit until 28 days after last subject discontinued study treatment
Eligibility criteria
Inclusion Criteria:
1. Subject is ≥18 years of age
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
3. Must have a documented diagnosis of CLL/SLL requiring treatment (IwCLL Guidelines for the Diagnosis and Treatment of CLL). In addition presence of clinically measurable disease determined by at least one of the factors listed:
* nodal lesion that measures ≥ 1.5 cm in longest dimension (LD) and ≥ 1.0 cm in longest perpendicular dimension (LPD), or
* spleen that measures ≥ 14 cm in longest vertical dimension (LVD) with a minimum of 2 cm enlargement, or
* liver that measures ≥ 20 cm in LVD with a minimum of 2 cm enlargement, or
* peripheral blood B lymphocyte count \> 5000/uL
4. All eligible subjects must be relapsed after or be refractory to \>2 prior lines of therapy one of which must have included an approved BTK inhibitor.
5. Must meet the following laboratory parameters:
1. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3 or ≥ 1000 cells/mm\^3 if secondary to bone marrow involvement by disease, without growth factor support for 7 days (14 days if pegfilgastrim).
2. Platelet count ≥ 75,000 cells/mm\^3 (100 x 10\^9/L) or ≥ 50,000 cells/mm\^3 (50 x 10\^9/L) if secondary to bone marrow involvement by disease, without transfusion for 7 days.
3. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) \< 3.0 x upper limit of normal (ULN).
4. Serum bilirubin \< 1.5 x ULN unless due to Gilbert's syndrome.
5. Calculated creatinine clearance of ≥ 60 ml/min.
Exclusion Criteria:
1. Presence of any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
2. Prior allogeneic stem cell transplant (SCT)/bone marrow transplant within 12 months of signing the ICF. Subjects who received allogeneic SCT ≥ 12 months before signing the ICF may be eligible provided there is no ongoing graft-versus-host disease and no ongoing immune suppression therapy.
3. Subject has received prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to starting CC-99282.
4. Subject has received prior therapy with CRBN-modulating drug (eg, lenalidomide, avadomide/CC-122, pomalidomide) ≤ 4 weeks prior to starting CC-99282.
5. History of second malignancies with life expectancy of ≤ 2 years or requirement of therapy that would confound study results.
6. Peripheral neuropathy ≥ Grade 2.
7. History of hypersensitivity to lenalidomide, pomalidomide, thalidomide.
8. Impaired cardiac function or clinically significant cardiac disease.
9. Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management.
10. Active disease transformation (ie, Richter's Syndrome)
11. Uncontrolled/active autoimmune hemolytic anemia or thrombocytopenia
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-03-14
1 organization
2 products
2 indications
Organization
CelgeneProduct
ObinutuzumabIndication
lymphomaIndication
Non-HodgkinProduct
CC-99282