NHLPhase 1NCT06385522
A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System
A Phase 1 study testing BITR2101 in people with NHL and Cutaneous T Cell Lymphoma, run by Boston Immune Technologies and Therapeutics.
Trial summary
The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NHL, Cutaneous T Cell Lymphoma, Peripheral T-cell Lymphoma
- What is being tested?
- BITR2101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed relapsed or refractory B cell NHL (DLBCL, MCL, MZL), PTCL or CTCL (MF or SS subtype) as per 2017 World Health Organization classification after at least 2 prior lines of systemic therapy and have received, or are not eligible for, approved or available treatments expected to provide benefit. CTCL patients should be Stage ≥1B through 4 and Stage 1A (see Appendix 1) with plaque disease without treatment options, in which case the patient should be discussed with the sponsor after submitting documentation of disease stage and treatment history. Patients with indolent lymphoid malignancies (CTCL, MZL) must need new treatment regimen in the opinion of the treating Investigator.
- Age ≥18 years.
- Life expectancy ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Who cannot join
- Patients with prior exposure (up to 12 months) to PD-1/PD-L1 therapies.
- Known hypersensitivity to any excipients that are used in the BITR2101 formulation as noted in Investigator Brochure.
- Autoimmune diseases that have been sufficiently active to require medications in the 3 months before screening, except autoimmune endocrinopathies, such as hypothyroidism, that are stable with hormone-replacement therapy. Including inflammatory diseases such as arthritis, colitis, liver fibrosis, cirrhosis, interstitial fibrosis or chronic obstructive pulmonary disease (COPD). The SRC may allow patients with well controlled arthritis or COPD in the expansion cohort if there is no indication of inflammatory disease flare and no blood cytokine evidence of a systemic inflammatory response in the 3 months prior to enrollment.
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with participating in the protocol.
- History or evidence of clinically significant cardiovascular disease.
- Severe dyspnea, pulmonary dysfunction, or need for continuous supportive oxygen inhalation.
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- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study for the duration of this study or the FU period of an interventional study.
- Prior or current anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy within 4 weeks of the first BITR2101 administration.
- Continuous corticosteroid use exceeding 10 mg/day prednisone or equivalent.
- Other protocol defined Inclusion/Exclusion criteria may apply
About this study
Official title: A Phase 1, First-In-Human, Open-Label, Dose-Escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Intravenous Doses of BITR2101 (Anti-TNFR2) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Including Cutaneous and Peripheral T Cell Lymphoma
The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year.
- Conditions
- NHL, Cutaneous T Cell Lymphoma, Peripheral T-cell Lymphoma
- Being tested
- BITR2101
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BITR2101Biological
TNFR2 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| BITR2101 | Experimental | Not described Receives: Biological: BITR2101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the safety and tolerability of BITR2101 administered intravenously every 3 weeks in order to determine the MTD, if any, and to inform the RDE
Measured: From enrollment to end of treatment, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study startAug 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHLStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Immune Technologies and Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385522
- Sponsor's protocol ID
- BITR2101-C-01
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-In-Human, Open-Label, Dose-Escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Intravenous Doses of BITR2101 (Anti-TNFR2) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Including Cutaneous and Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06385522
- Acronym / sponsor ID
- BITR2101-C-01
- Conditions
- NHL, Cutaneous T Cell Lymphoma, Peripheral T-cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Boston Immune Technologies and TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 26 Apr 2024 (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.
The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BITR2101 | Experimental | Biological: BITR2101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed relapsed or refractory B cell NHL (DLBCL, MCL, MZL), PTCL or CTCL (MF or SS subtype) as per 2017 World Health Organization classification after at least 2 prior lines of systemic therapy and have received, or are not eligible for, approved or available treatments expected to provide benefit. CTCL patients should be Stage ≥1B through 4 and Stage 1A (see Appendix 1) with plaque disease without treatment options, in which case the patient should be discussed with the sponsor after submitting documentation of disease stage and treatment history. Patients with indolent lymphoid malignancies (CTCL, MZL) must need new treatment regimen in the opinion of the treating Investigator.
- Age ≥18 years.
- Life expectancy ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (10 listed)
- Patients with prior exposure (up to 12 months) to PD-1/PD-L1 therapies.
- Known hypersensitivity to any excipients that are used in the BITR2101 formulation as noted in Investigator Brochure.
- Autoimmune diseases that have been sufficiently active to require medications in the 3 months before screening, except autoimmune endocrinopathies, such as hypothyroidism, that are stable with hormone-replacement therapy. Including inflammatory diseases such as arthritis, colitis, liver fibrosis, cirrhosis, interstitial fibrosis or chronic obstructive pulmonary disease (COPD). The SRC may allow patients with well controlled arthritis or COPD in the expansion cohort if there is no indication of inflammatory disease flare and no blood cytokine evidence of a systemic inflammatory response in the 3 months prior to enrollment.
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with participating in the protocol.
- History or evidence of clinically significant cardiovascular disease.
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 |
|---|---|---|
| BITR2101TNFR2 monoclonal antibody | Biological | BITR2101 |
Primary outcome
to assess the safety and tolerability of BITR2101 administered intravenously every 3 weeks in order to determine the MTD, if any, and to inform the RDE
Time frame: From enrollment to end of treatment, up to 2 years
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 8 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BITR2101 in people with NHL and Cutaneous T Cell Lymphoma, run by Boston Immune Technologies and Therapeutics.
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the safety and tolerability of BITR2101 administered intravenously every 3 weeks in order to determine the MTD, if any, and to inform the RDE (time frame: From enrollment to end of treatment, up to 2 years). 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 8 Jul 2025.