Actively Recruiting
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Led by M.D. Anderson Cancer Center · Updated on 2026-03-09
40
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.
CONDITIONS
Official Title
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of intermediate, high, or very high risk MDS by IPSS-R, untreated or with up to 2 prior treatments (Arm 1)
- Diagnosis of relapsed or refractory AML receiving first or second salvage treatment (Arm 2)
- ECOG performance status of 0, 1, or 2
- Allowed temporary prior treatments such as apheresis, limited dose cytarabine, or hydrea during eligibility evaluation
- At least 2 weeks or 5 half-lives interval from prior treatment before starting study therapy unless rapid disease progression
- Toxicity from prior therapy resolved to Grade 1 or less, except alopecia and sensory neuropathy Grade 2 or less if not a safety risk
- No other chemotherapeutic agents allowed during study except specified exceptions
- Treated and stable CNS leukemia patients meeting specific criteria
- Adequate renal function with creatinine clearance of 40 mL/min or higher
- Direct bilirubin less than 1.5 times the upper limit of normal unless due to Gilbert's syndrome
- AST or ALT less than or equal to twice the upper limit of normal (up to three times if related to leukemia)
- White blood cell count below 10 x 10^9/L; hydroxyurea allowed to reduce count
- Ability to understand and sign informed consent
- Women must be surgically or biologically sterile, postmenopausal, or have a negative pregnancy test within 72 hours before treatment
- Women of childbearing potential and men must agree to use contraception during and after the study
You will not qualify if you...
- Any other severe or uncontrolled medical condition such as diabetes, cardiovascular disease, renal disease, or active infection
- Receiving active chemotherapy or radiation for another cancer at screening, except maintenance, hormonal, or steroid therapy for well-controlled malignancy
- Prior organ transplant including stem-cell transplant within 3 months before enrollment or active graft versus host disease requiring significant immunosuppression
- Symptomatic or poorly controlled central nervous system leukemia
- Known uncontrolled HIV infection
- Known positive hepatitis B or C infection unless viral load is undetectable within 3 months
- Major surgery within 14 days before starting treatment
- Severe active acute or chronic medical conditions including colitis, inflammatory bowel disease, or psychiatric conditions that increase risk
- Active uncontrolled infections or heart conditions
- Requirement for anti-TNF drugs
- Unwillingness or inability to comply with the study protocol
- Receipt of live vaccine within 28 days before starting treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Gautam Borthakur, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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