Lymphoma, T Cell, PeripheralPhase 1NCT07388563
Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
A Phase 1 study testing azacitidine and abatacept in people with Lymphoma, T Cell, Peripheral and T-cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: T-cell lymphoma is a blood cancer that affects immune system cells. People tend to survive less than 1 year if this disease does not respond to treatment (is refractory) or comes back after treatment (relapses). Azacitidine and abatacept are 2 drugs that are used to treat other diseases. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma, T Cell, Peripheral, T-cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- azacitidine and abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any second malignancy that requires current active systemic therapy.
- Latent tuberculosis (TB) infection.
- Active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring anti-infective treatment within 1 day prior to the study treatment initiation.
- 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.
- Any investigational therapy within 2 weeks prior to the study treatment initiation.
- Known allergy or hypersensitivity to any of the study drugs.
Show all 9Show fewer
- Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening.
- 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.
- Uncontrolled intercurrent illness, factors, evaluated by medical history, electrocardiogram (EKG), and physical exam that would potentially increase in risk of participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@mail.nih.gov
About this study
Official title: A Phase I Trial of Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
Background:
T-cell lymphoma is a blood cancer that affects immune system cells. People tend to survive less than 1 year if this disease does not respond to treatment (is refractory) or comes back after treatment (relapses). Azacitidine and abatacept are 2 drugs that are used to treat other diseases. Researchers want to know if these drugs, used together, can help people with T-cell lymphoma.
Read more
Objective:
To learn if azacitidine combined with abatacept can shrink tumors in people with T-cell lymphoma.
Eligibility:
People aged 18 years and older with T-cell lymphoma that either came back or did not respond to treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken.
Azacitidine is injected under the skin of the thigh, abdomen, or upper arm. Abatacept is infused through a needle inserted into a vein in the arm.
Participants will receive the study drugs in 28-day cycles for up to 13 cycles. They will come to the clinic for each treatment. They will come to the clinic on day 1 and day 15 of the first cycle. After that, they will come to the clinic on the first 5 or 7 days of each cycle. Each clinic visit will take no more than 8 hours.
Imaging scans and other tests will be repeated during the study. Participants will have follow-up visits for up to 5 years after they stop taking the study drugs....
Read the detailed description
Background:
- Relapsed or refractory T-cell lymphoma is typically incurable with a median survival of less than 1 year. Angioimmunoblastic T-cell lymphoma (AITL) is the most commonly defined subtype of T-cell lymphoma and has a similarly poor prognosis.
- We have developed the first AITL cell lines that maintain immunophenotypic fidelity with AITL and used these cell lines to identify novel therapies for patients with AITL.
- We found that CD28 blockade with the Food and Drug Administration (FDA)-approved rheumatologic agent abatacept, which blocks CD28 signaling, impaired the proliferation of AITL cell lines, and that injection of abatacept into patient-derived xenograft (PDX) models of AITL significantly prolonged their survival. Based on this we conclude that targeting CD28 with abatacept in AITL is a promising, novel therapeutic approach that warrants clinical testing in people with relapsed/refractory (R/R) T-cell lymphoma.
- Abatacept can be combined with the deoxyribonucleic acid (DNA) methyltransferase inhibitor azacitidine, which has been shown to be preferentially active in patients with a TET2 mutation, the most common genetic abnormality in patients with AITL. We confirmed that azacitidine indeed inhibits AITL cell lines synergistically with abatacept.
Objectives:
- Arm 1: To estimate the maximum tolerated dose (MTD) of the combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma.
- Arm 2: To estimate the complete response rate (CRR) of the combination of azacitidine and abatacept.
Eligibility:
- Participants >= 18 years with relapsed or refractory T-cell lymphoma after initial systemic treatment.
- Adequate organ and marrow function.
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Design:
- This is a non-randomized, open-label, single-site phase I trial evaluating the combination of azacitidine and abatacept.
- Treatment will be delivered in cycles consistent of 28 days.
- During Cycle 0 abatacept will be administered intravenously on Days 1 and 15.
- During Cycles 1-6 abatacept administered on Day 1 will be combined with subcutaneous azacitidine delivered on Days 1-5 or Days 1-7.
- After Cycle 6 participants will be evaluated and participants who have a response will get additional 6 cycles of the monotherapy with azacitidine.
- Conditions
- Lymphoma, T Cell, Peripheral, T-cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Monomorphic Epitheliotropic Intestinal T-cell Lymphoma, Adult T-cell Leukemia/Lymphoma
- Being tested
- azacitidine, abatacept
- Keywords
- Selective Costimulation Modulators, Immunomodulators, Biological Therapy, Chemotherapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azacitidineDrug
Days 1-5 or 1-7 of every cycle (12 cycles): azacitidine subcutaneous or IV at the dose of 75 mg/m2
abataceptDrug
Cycle 0, Days 1 and 15: abatacept IV infusions at the dose of 5 mg/kg or 10 mg/kg. Cycles 1-6, Day 1: abatacept IV infusions at the dose of 5 mg/kg or 10 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Escalating/de-escalating doses of azacitidine + abatacept Receives: Drug: azacitidine; Drug: abatacept |
| Arm 2 | Experimental | MTD of azacitidine + abatacept if less than 12 participants are enrolled in Arm 1 Receives: Drug: azacitidine; Drug: abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm 2: To estimate the CRR of the combination of azacitidine and abatacept.
Complete response rate (CRR) will be evaluated in Arm 2 in participants treated at MTD. CRR will be estimated along with a 95% confidence interval (CI).
Measured: Day 1 of Cycles 1, 4, 7, 10, EOT/PD visit, every 3 months for years 1-2, every 6 months for years 3-4, once a year for year 5.
Arm 1: To estimate the MTD of the combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma.
MTD will be determined based on the DLT profile during the DLT window in Arm 1 56 days (cycles 0-1).
Measured: 56 days (cycles 0-1)
Secondary outcomes (2)
To determine the ORR defined as CR + PR to the combination of azacitidine and abatacept
ORR will be estimated along with a 95% CI. Every report of response rates will contain all participants included in the study.
Measured: Day 1 of every cycle then at the EOT/PD visit, every 3 months for years 1-2, every 6 months for years 3-4, then once a year until progression, initiation of another line of therapy, or 5 years since treatment initiation.
To determine the safety profile of a combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma
The number and frequency of adverse events for participants as assessed per CTCAE version 6. Safety will be analyzed by reporting the number of patients experiencing toxicity, classified by type and maximum grade to the experimental regimen.
Measured: Day 1 through 30 days after the last study intervention was administered or before the initiation of a new anti-cancer treatment, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start26 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T Cell, PeripheralStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Samuel Y Ng, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388563
- Sponsor's protocol ID
- 10002363
- Other IDs
- 002363-C
- Status last verified
- 14 Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07388563
- Acronym / sponsor ID
- 10002363
- Conditions
- Lymphoma, T Cell, Peripheral, T-cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Monomorphic Epitheliotropic Intestinal T-cell Lymphoma, Adult T-cell Leukemia/Lymphoma
- Keywords
- Selective Costimulation Modulators, Immunomodulators, Biological Therapy, Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
T-cell lymphoma is a blood cancer that affects immune system cells. People tend to survive less than 1 year if this disease does not respond to treatment (is refractory) or comes back after treatment (relapses). Azacitidine and abatacept are 2 drugs that are used to treat other diseases. Researchers want to know if these drugs, used together, can help people with T-cell lymphoma.
Objective:
To learn if azacitidine combined with abatacept can shrink tumors in people with T-cell lymphoma.
Eligibility:
People aged 18 years and older with T-cell lymphoma that either came back or did not respond to treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken.
Azacitidine is injected under the skin of the thigh, abdomen, or upper arm. Abatacept is infused through a needle inserted into a vein in the arm.
Participants will receive the study drugs in 28-day cycles for up to 13 cycles. They will come to the clinic for each treatment. They will come to the clinic on day 1 and day 15 of the first cycle. After that, they will come to the clinic on the first 5 or 7 days of each cycle. Each clinic visit will take no more than 8 hours.
Imaging scans and other tests will be repeated during the study. Participants will have follow-up visits for up to 5 years after they stop taking the study drugs....
Detailed description
Background:
- Relapsed or refractory T-cell lymphoma is typically incurable with a median survival of less than 1 year. Angioimmunoblastic T-cell lymphoma (AITL) is the most commonly defined subtype of T-cell lymphoma and has a similarly poor prognosis.
- We have developed the first AITL cell lines that maintain immunophenotypic fidelity with AITL and used these cell lines to identify novel therapies for patients with AITL.
- We found that CD28 blockade with the Food and Drug Administration (FDA)-approved rheumatologic agent abatacept, which blocks CD28 signaling, impaired the proliferation of AITL cell lines, and that injection of abatacept into patient-derived xenograft (PDX) models of AITL significantly prolonged their survival. Based on this we conclude that targeting CD28 with abatacept in AITL is a promising, novel therapeutic approach that warrants clinical testing in people with relapsed/refractory (R/R) T-cell lymphoma.
- Abatacept can be combined with the deoxyribonucleic acid (DNA) methyltransferase inhibitor azacitidine, which has been shown to be preferentially active in patients with a TET2 mutation, the most common genetic abnormality in patients with AITL. We confirmed that azacitidine indeed inhibits AITL cell lines synergistically with abatacept.
Objectives:
- Arm 1: To estimate the maximum tolerated dose (MTD) of the combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma.
- Arm 2: To estimate the complete response rate (CRR) of the combination of azacitidine and abatacept.
Eligibility:
- Participants >= 18 years with relapsed or refractory T-cell lymphoma after initial systemic treatment.
- Adequate organ and marrow function.
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Design:
- This is a non-randomized, open-label, single-site phase I trial evaluating the combination of azacitidine and abatacept.
- Treatment will be delivered in cycles consistent of 28 days.
- During Cycle 0 abatacept will be administered intravenously on Days 1 and 15.
- During Cycles 1-6 abatacept administered on Day 1 will be combined with subcutaneous azacitidine delivered on Days 1-5 or Days 1-7.
- After Cycle 6 participants will be evaluated and participants who have a response will get additional 6 cycles of the monotherapy with azacitidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: azacitidine, Drug: abataceptEscalating/de-escalating doses of azacitidine + abatacept |
| Arm 2 | Experimental | Drug: azacitidine, Drug: abataceptMTD of azacitidine + abatacept if less than 12 participants are enrolled in Arm 1 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Any second malignancy that requires current active systemic therapy.
- Latent tuberculosis (TB) infection.
- Active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring anti-infective treatment within 1 day prior to the study treatment initiation.
- 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.
- Any investigational therapy within 2 weeks prior to the study treatment initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| azacitidineDays 1-5 or 1-7 of every cycle (12 cycles): azacitidine subcutaneous or IV at the dose of 75 mg/m2 | Drug | Arm 1, Arm 2 |
| abataceptCycle 0, Days 1 and 15: abatacept IV infusions at the dose of 5 mg/kg or 10 mg/kg. Cycles 1-6, Day 1: abatacept IV infusions at the dose of 5 mg/kg or 10 mg/kg. | Drug | Arm 1, Arm 2 |
Primary outcome
Arm 2: To estimate the CRR of the combination of azacitidine and abatacept.
Time frame: Day 1 of Cycles 1, 4, 7, 10, EOT/PD visit, every 3 months for years 1-2, every 6 months for years 3-4, once a year for year 5.
Complete response rate (CRR) will be evaluated in Arm 2 in participants treated at MTD. CRR will be estimated along with a 95% confidence interval (CI).
Arm 1: To estimate the MTD of the combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma.
Time frame: 56 days (cycles 0-1)
MTD will be determined based on the DLT profile during the DLT window in Arm 1 56 days (cycles 0-1).
2 secondary outcomes
To determine the ORR defined as CR + PR to the combination of azacitidine and abatacept
Time frame: Day 1 of every cycle then at the EOT/PD visit, every 3 months for years 1-2, every 6 months for years 3-4, then once a year until progression, initiation of another line of therapy, or 5 years since treatment initiation.
To determine the safety profile of a combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma
Time frame: Day 1 through 30 days after the last study intervention was administered or before the initiation of a new anti-cancer treatment, whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.
Related trials for Lymphoma, T Cell, Peripheral
Active, not recruitingPhase 1
Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma
Advanced Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
Active, not recruitingPhase 2
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Peripheral T-cell Lymphomas, Lymphoproliferative Disorders
RecruitingPhase 3
Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
Lymphoma, T-Cell, Peripheral
RecruitingPhase 2
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
Acute Leukemia, Acute Lymphoblastic Leukemia
RecruitingPhase 2
Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas
Follicular Helper T-Cell Lymphoma, Peripheral T-Cell Lymphoma, Not Otherwise Specified
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Y Ng, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing azacitidine and abatacept in people with Lymphoma, T Cell, Peripheral and T-cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact National Cancer Institute Referral Offic ((888) 624-1937, ncimo_referrals@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm 2: To estimate the CRR of the combination of azacitidine and abatacept. (time frame: Day 1 of Cycles 1, 4, 7, 10, EOT/PD visit, every 3 months for years 1-2, every 6 months for years 3-4, once a year for year 5.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.