The purpose of this study is to evaluate the safety and efficacy of Zola-cel (BMS-986353), in participants with chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Specified dose of specified days
Specified dose of specified days
Specified dose on specified days
Local Institution - 101
Boston, Massachusetts, United States
Local Institution - 103
Houston, Texas, United States
Local Institution - 102
Seattle, Washington, United States
Local Institution - 201
Odense, Denmark
Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately Month 36
Cohort 1 Part A: Number of participants with serious AEs (SAEs)
Time frame: Up to approximately Month 36
Cohort 1 Part A: Number of participants with AEs of special interest (AESI)
Time frame: Up to approximately Month 36
Cohort 1 Part A: Number of participants with clinically significant laboratory abnormalities
Time frame: Up to approximately Month 36
Cohort 1 Part B: Hematologic Complete Response (CR)
Time frame: Up to approximately Month 6
Cohort 1 PART B: Hematologic Overall Response (OR)
Time frame: Up to approximately Month 6
Cohort 1 PART A and Cohort 2: Hematologic CR and OR
Time frame: Up to approximately Month 6
Cohort 1 PART B and Cohort 2: Number of participants with TEAEs
Time frame: Up to approximately Month 36
Cohort 1 PART B and Cohort 2: Number of participants with SAEs
Time frame: Up to approximately Month 36
Cohort 1 PART B and Cohort 2: Number of participants with AESIs
Time frame: Up to approximately Month 36
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Local Institution - 301
Magdeburg, Saxony-Anhalt, Germany
Local Institution - 302
Erlangen, Germany
Local Institution - 401
London, Greater London, United Kingdom
Local Institution - 402
Sheffield, United Kingdom
Cohort 1 PART B and Cohort 2: Number of participants with clinically significant laboratory abnormalities
Time frame: Up to approximately Month 36
Number of participants with Hematologic PR
Time frame: Up to approximately Month 6
Number of participants with Hematologic CR
Time frame: Up to approximately Month 36
Number of participants with Hematologic PR
Time frame: Up to approximately Month 36
Number of participants with Hematologic OR
Time frame: Up to approximately Month 36
Number of participants with Best Overall Response (BOR)
Time frame: Up to approximately Month 36
Number of participants with durable CR, PR and OR
Time frame: Up to approximately 12 months from Zola-cel infusion
Time to First Response (TTR)
Time frame: Up to approximately Month 36
Time to First Complete Response (TTCR)
Time frame: Up to approximately Month 36
Duration of response (DOR)
Time frame: Up to approximately Month 36
Treatment-free Remission (TFR)
Time frame: Up to approximately Month 36
Proportion of participants who requires rescue therapy for ITP or AIHA
Time frame: Up to approximately Month 36
Time to first administration of rescue therapy for ITP or AIHA
Time frame: Up to approximately Month 36
Proportion of AIHA participants who experience hemolysis features
Time frame: Up to approximately Month 36
Number of AIHA participants with cold agglutinin disease (CAD) who experience acrocyanosis
Time frame: Up to approximately Month 36
Change from baseline in hemolysis indicators in AIHA participants
Time frame: Up to approximately Month 36
Proportion of ITP participants with WHO-classified bleeding events as assessed by WHO bleeding scale
Time frame: Up to approximately Month 36
Change from baseline in 36-Item Short Form Health Questionnaire version 2 (SF-36 v2)
Time frame: Up to approximately Month 36
Change from baseline in Patient Global Impression of Severity (PGI-S) Fatigue score
Time frame: Up to approximately Month 36
Patient Global Impression of Change (PGI-C) Fatigue mean score
Time frame: Up to approximately Month 36
Change from baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP - PAQ) score
Time frame: Up to approximately Month 36
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score
Time frame: Up to approximately Month 36