Actively Recruiting
A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
32
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Sobi, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART.
CONDITIONS
Official Title
A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with relapsed or refractory follicular lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma, or high-grade B-cell lymphoma
- Received standard CAR T-cell therapies axi-cel, tisa-cel, or liso-cel
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- In remission after CAR T-cell therapy or have refractory/progressive disease not requiring urgent treatment
- Grade 3-4 cytopenia persisting or starting between day 30 and day 90 after CAR T-cell therapy, defined as neutrophil count <1.0x10^9/L, platelet count <50x10^9/L, or hemoglobin <8 g/dL
- Creatinine clearance ≥30 mL/min
- Serum alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 times upper limit of normal
- Total bilirubin ≤1.5 mg/dL, or ≤3 mg/dL in participants with Gilbert's syndrome
- Baseline oxygen saturation >92% on room air
- Negative pregnancy test for females of childbearing potential
- Willingness to undergo bone marrow biopsy before and after each treatment cycle and at recurrence of severe cytopenia
- Agreement to use adequate contraception prior to study and for 6 months after emapalumab administration
- Ability to understand and sign informed consent
- Tested for latent tuberculosis infection and managed accordingly
You will not qualify if you...
- History of malignancy other than nonmelanoma skin cancer or localized carcinoma unless disease-free for at least 3 years
- History of Richter's transformation of chronic lymphocytic leukemia
- Grade 3-4 cytopenia before starting lymphodepleting chemotherapy for CAR T-cell therapy
- Cytopenia caused by experimental non-commercial CAR T-cell therapy
- Bone marrow evidence of lymphoma, hypersplenism, hemophagocytic lymphohistiocytosis, or second malignancy contributing to cytopenia without other identifiable cause
- Relapsed or progressive disease requiring immediate anti-lymphoma treatment
- Uncontrolled infections requiring intravenous antimicrobial treatment
- Known HIV or active hepatitis B or C infections
- Significant cardiac disease or events within 6 months prior to enrollment
- History of primary immunodeficiency
- Recent symptomatic deep vein thrombosis or pulmonary embolism
- Medical conditions interfering with study treatment assessment
- Severe hypersensitivity to study agents including E. coli-derived proteins
- Receipt of BCG vaccine within 12 weeks or other live vaccines within 4 weeks before screening
- Pregnant or breastfeeding women of childbearing potential
- Unwillingness to use adequate contraception during study and 6 months after
- Inability or unwillingness to complete study visits or comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Paolo Strati, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here