Azacitidine and abatacept for relapsed or refractory T-cell lymphoma
Official title: A Phase I Trial of Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
Run by National Institutes of Health Clinical Center (CC) · NCT07388563 · Data updated 2026-11-12
This study tests a combination of azacitidine and abatacept to see if it can shrink tumors in adults whose T-cell lymphoma has come back or not responded to treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | prednisone |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | March 26, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07388563 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with relapsed or refractory T-cell lymphoma, including PTCL, NOS, AITL, TFH lymphoma, ALCL, EATL, MEITL, ATLL, or other TCL, who have evaluable disease and adequate organ function.
✕Probably not a fit
Patients with disease that does not respond to the therapy or who cannot tolerate the combination due to toxicity may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional trial at the NIH Clinical Center evaluating the combination of azacitidine and abatacept for relapsed or refractory T-cell lymphoma. The study aims to determine the maximum tolerated dose and the rate of complete tumor responses. Participants will undergo screening with physical exams, blood tests, heart function tests, imaging, and possibly tumor tissue sampling. Azacitidine is given subcutaneously and abatacept is delivered by IV infusion. The trial includes adults with various T-cell lymphoma subtypes and requires evaluable disease and adequate organ function.
Why it matters
Potential benefit: If successful, the combination could offer a new treatment option that might shrink tumors and extend disease control for some patients.
How similar studies have gone: Preclinical and early data suggested that targeting CD28 with abatacept and combining with azacitidine could be active in T-cell lymphoma, supporting clinical testing in humans.
Who can join: the full rules
Show full inclusion / exclusion criteria
-INCLUSION CRITERIA
1. Participants must have a histologically or cytologically confirmed T-cell lymphoma confirmed by the Laboratory of Pathology (LP), NCI. The one of the following T-cell lymphomas are included:
* Peripheral T-cell lymphoma not otherwise specified (PTCL, NOS)
* Angioimmunoblastic T-cell lymphoma (AITL)
* T-follicular helper (TFH) lymphoma
* Anaplastic large cell lymphoma (ALCL)
* Enteropathy-associated T-cell lymphoma (EATL)
* Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)
* Adult T-cell leukemia/lymphoma (ATLL)
* Other T-cell lymphoma (TCL)
2. Participants must have a disease that is relapsed or refractory after initial systemic treatment.
3. Participants must have evaluable disease on screening imaging or by laboratory assessment.
4. Age \>= 18 years.
5. ECOG performance status \<= 2.
6. Participants must have adequate organ and marrow function as defined below:
* Absolute neutrophil count (ANC) / \>= 1,000 cells/mcL OR \>= 500 cells/mcL if bone marrow involvement with lymphoma
* Platelets / \>= 50,000 cells/mcL OR \>= 25,000 cells/mcL if bone marrow involvement with lymphoma
* Hemoglobin / \>= 8 g/dL (transfusions permitted)
* Renal function / Serum creatinine \<= 2 mg/dL OR Glomerular filtration rate (GFR) \>= 40 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease (MDRD).
Note: there is no limit if involved by lymphoma.
If not on target, a 24-hour urine creatinine clearance can be used to directly measure creatinine clearance.
* Total bilirubin / \<= 1.5 x upper limit of normal (ULN)
* Aspartate Aminotransferase (AST) / \<= 3.0 x ULN
* Alanine Aminotransferase (ALT) / \<= 3.0 x ULN
* Prothrombin time (PT) / \<1.5 x ULN
* Activated partial thromboplastin time (aPTT) / \<1.5 x ULN; \< 5.0 x ULN if the aPTT is prolonged because of a positive Lupus Anticoagulant
International normalized ratio (INR) / \<1.5 x ULN
7. Participants, seropositive for human immunodeficiency virus (HIV), must have an undetectable HIV viral load.
8. Participants, seropositive for hepatitis C virus (HCV) infection, must have been treated and have an undetectable HCV viral load.
9. Participants who are hepatitis B core antibody (HBcAb) positive must have a hepatitis B virus (HBV) viral load result \<100 IU/mL. Note: participants who are hepatitis B surface antigen (HBsAg) positive are excluded.
10. Participants with detectable Epstein-Barr virus (EBV) or Cytomegalovirus (CMV) by polymerase chain reaction will be eligible provided they do not have end organ dysfunction from EBV or CMV infection.
11. Participants with pulmonary disease such as chronic obstructive pulmonary disease and non-infectious liver disease who otherwise meet the requirements.
12. Women of child-bearing potential (WOCBP) must agree to use effective methods of contraception (barrier, hormonal, surgical sterilization, abstinence) during the study treatment and for 6 months after the completion of the study treatment. Note: WOCBP is defined as any woman who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.
Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) during the study treatment and for 3 months after the completion of the study treatment. These men must not freeze or donate sperm within the same period.
13. Nursing participants must be willing to discontinue nursing from study treatment initiation through six (6) months after the last dose of the study drug(s).
14. Ability of the participant to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
1. Any second malignancy that requires current active systemic therapy.
2. Latent tuberculosis (TB) infection.
3. Active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring anti-infective treatment within 1 day prior to the study treatment initiation.
4. Anti-cancer therapy within 2 weeks prior to the study treatment initiation. Note: systemic steroids are allowed if \<= 100 mg/per day of prednisone (or equivalent) and were used for \<= 7 days during 2 weeks before the study treatment initiation.
5. Any investigational therapy within 2 weeks prior to the study treatment initiation.
6. Known allergy or hypersensitivity to any of the study drugs.
7. Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening.
8. Active central nervous system involvement with lymphoma. Previously treated central nervous system involvement with lymphoma will be allowed if \>3 months since end of treatment.
9. Uncontrolled intercurrent illness, factors, evaluated by medical history, electrocardiogram (EKG), and physical exam that would potentially increase in risk of participant.
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Samuel Y Ng, M.D. — National Cancer Institute (NCI)
- Study coordinator: National Cancer Institute Referral Offic
- Email: ncimo_referrals@mail.nih.gov
- Phone: (888) 624-1937
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.