Aggressive B-cell Non-Hodgkin Lymphoma (aNHL)Phase 2NCT07883135
Bispecific Antibody-Based Holding/Bridging Therapy Before CAR-T in Aggressive B-Cell Lymphomas
A Phase 2 study testing Glofitamab, Epcoritamab and Polatuzumab Vedotin in people with Aggressive B-cell Non-Hodgkin Lymphoma (aNHL) and Relapsed or Refractory B-cell Lymphoma, run by National Research Center for Hematology, Russia at 1 site in Russia.
Trial summary
This prospective, single-center, open-label study evaluates a short course of CD20×CD3 bispecific antibody-based holding or bridging therapy before CD19-directed CAR T-cell therapy in adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggressive B-cell Non-Hodgkin Lymphoma (aNHL), Relapsed or Refractory B-cell Lymphoma
- What is being tested?
- Glofitamab, Epcoritamab and Polatuzumab Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2026to 1 Aug 2029
- Phase
- Phase 2
- 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
- Age 18 years or older.
- Ability to understand the study requirements and provide written informed consent.
- Histologically confirmed relapsed or refractory aggressive mature B-cell non-Hodgkin lymphoma.
- Failure of at least one prior line of systemic anticancer therapy.
- Documented CD19 expression on tumor cells by immunohistochemistry and/or flow cytometry/immunophenotyping of current disease.
- Considered eligible for CD19-directed CAR T-cell therapy by the treating multidisciplinary team, with no absolute contraindication to CAR T-cell therapy at the time of enrollment.
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- At least one measurable FDG-avid lesion according to Lugano 2014 criteria.
- Baseline PET/CT performed within 28 days before enrollment.
- ECOG performance status 0-2.
- Life expectancy of at least 12 weeks.
- No severe uncontrolled comorbid condition that would preclude protocol therapy.
- Women of childbearing potential must have a negative pregnancy test before study treatment and agree to use highly effective contraception; male participants must agree to follow protocol-specified contraceptive requirements.
Who cannot join
- Prior treatment with a CD20×CD3 bispecific antibody.
- Absence of confirmed CD19 expression on tumor cells.
- No indication for, or any contraindication to, CD19-directed CAR T-cell therapy.
- ECOG performance status ≥3.
- Uncontrolled bacterial, viral, fungal, or opportunistic infection, including sepsis.
- Active hepatitis B or C infection, HIV infection, or syphilis.
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- Concurrent active malignancy not in remission.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Ongoing systemic corticosteroid therapy at a dose equivalent to >10 mg/day of prednisone, except physiologic replacement therapy or protocol-required premedication.
- Clinically significant uncontrolled cardiovascular, pulmonary, neurologic, or psychiatric disease.
- Grade ≥2 peripheral sensory or motor neuropathy according to CTCAE.
- Known hypersensitivity to any study drug or its components.
- Pregnancy or breastfeeding.
- Any other condition that, in the investigator's judgment, would place the participant at unacceptable risk or interfere with study treatment or required study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
National Research Center for Hematology
Moscow, Moscow, 125167
About this study
Official title: A Non-Randomized Prospective Single-Center Open-Label Study With Two Parallel Therapeutic Cohorts to Evaluate the Efficacy and Safety of a CD20×CD3 Bispecific Antibody in Combination With GemOx or Polatuzumab Vedotin as Holding/Bridging Therapy in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphomas Before CAR T-Cell Therapy
This prospective, single-center, open-label study evaluates a short course of CD20×CD3 bispecific antibody-based holding or bridging therapy before CD19-directed CAR T-cell therapy in adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
Participants will receive a CD20×CD3 bispecific antibody in combination with either GemOx or polatuzumab vedotin. Treatment assignment is based on prior therapy. The study will evaluate the antitumor activity and safety of this strategy, the proportion of patients who are able to proceed to planned CAR T-cell therapy, and clinical outcomes after CAR T-cell infusion.
- Being tested
- Glofitamab, Epcoritamab, Polatuzumab Vedotin, Gemcitabine & oxaliplatin, Obinutuzumab
- Keywords
- CAR T-cell therapy, Bispecific antibody, Bridging therapy, Holding therapy, CD20xCD3, Relapsed refractory lymphoma
- Medical subject headings
- Recurrence, Lymphoma, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlofitamabDrug
Glofitamab administered according to the protocol-specified step-up dosing schedule, followed by two full doses in combination with either polatuzumab vedotin or GemOx.
EpcoritamabDrug
Epcoritamab administered according to the protocol-specified step-up dosing schedule, followed by two full doses in combination with either polatuzumab vedotin or GemOx.
Polatuzumab VedotinDrug
Polatuzumab vedotin 1.8 mg/kg administered intravenously once per cycle for two cycles in combination with the protocol-specified CD20xCD3 bispecific antibody.
Gemcitabine & oxaliplatinDrug
Gemcitabine 1000 mg/m² and oxaliplatin 100 mg/m² administered intravenously once every 21 days for two cycles in combination with the protocol-specified CD20xCD3 bispecific antibody.
ObinutuzumabDrug
Obinutuzumab 1000 mg administered intravenously as protocol-specified pretreatment before initiation of glofitamab step-up dosing.
| Study group | Role | What they receive |
|---|---|---|
| CD20xCD3 Bispecific Antibody + Polatuzumab Vedotin | Experimental | Participants with prior platinum-containing therapy will receive a CD20xCD3 bispecific antibody (glofitamab or epcoritamab) in combination with polatuzumab vedotin as holding or bridging therapy before planned CD19-directed CAR T-cell therapy. Receives: Drug: Glofitamab; Drug: Epcoritamab; Drug: Polatuzumab Vedotin; Drug: Obinutuzumab |
| CD20xCD3 Bispecific Antibody + GemOx | Experimental | Participants without prior platinum-containing therapy will receive a CD20xCD3 bispecific antibody (glofitamab or epcoritamab) in combination with GemOx as holding or bridging therapy before planned CD19-directed CAR T-cell therapy. Receives: Drug: Glofitamab; Drug: Epcoritamab; Drug: Gemcitabine & oxaliplatin; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate After Two Cycles of Holding/Bridging Therapy
Proportion of participants achieving a complete or partial metabolic response according to Lugano 2014 criteria using the Deauville 5-point scale.
Measured: 14 to 21 days after completion of the second 21-day combination cycle, before leukapheresis in the holding pathway or before lymphodepletion in the bridging pathway.
Secondary outcomes (6)
Proportion of Participants Receiving CAR T-Cell Infusion
Number and proportion of enrolled participants who receive the planned CAR T-cell infusion.
Measured: Assessed at the time of planned CAR T-cell infusion, following completion of holding/bridging therapy.
Incidence and Severity of Adverse Events During Holding/Bridging Therapy
Number and proportion of participants with adverse events (AEs), Grade 3 or higher AEs, serious adverse events (SAEs), cytokine release syndrome (CRS), ICANS, infections, cytopenias, peripheral neuropathy, treatment delays, treatment discontinuations, and deaths. AEs will be graded according to CTCAE v6.0; CRS and ICANS will be graded according to ASTCT 2019 criteria.
Measured: From the first dose of study treatment through the start of lymphodepletion, up to approximately 12 weeks
Safety of CAR T-Cell Therapy After Bispecific Antibody-Based Holding/Bridging Therapy
Number and proportion of participants experiencing cytokine release syndrome (CRS), ICANS, IEC-HS, cytopenias, infections, Grade 3 or higher adverse events, and serious adverse events after CAR T-cell infusion. CRS, ICANS, and IEC-HS will be assessed according to ASTCT criteria, and adverse events will be graded according to CTCAE v6.0.
Measured: From CAR T-cell infusion through Day +90; primary safety assessment through Day +28 with additional assessment through Day +90.
Objective Response Rate After CAR T-Cell Therapy
Proportion of participants achieving a complete or partial metabolic response according to Lugano 2014 criteria.
Measured: Day +28 and Day +90 after CAR T-cell infusion
Event-Free Survival
Time from CAR T-cell infusion to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first.
Measured: Up to 12 months after CAR T-cell infusion
Overall Survival
Time from CAR T-cell infusion to death from any cause.
Measured: Up to 12 months after CAR T-cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startSep 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive B-cell Non-Hodgkin Lymphoma (aNHL)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Elena Parovichnikova, MD, DSc, Principal investigator, National Research Center for Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883135
- Sponsor's protocol ID
- R/R-B-aNHL-2026
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Non-Randomized Prospective Single-Center Open-Label Study With Two Parallel Therapeutic Cohorts to Evaluate the Efficacy and Safety of a CD20×CD3 Bispecific Antibody in Combination With GemOx or Polatuzumab Vedotin as Holding/Bridging Therapy in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphomas Before CAR T-Cell Therapy
- ClinicalTrials.gov ID
- NCT07883135
- Acronym / sponsor ID
- R/R-B-aNHL-2026
- Keywords
- CAR T-cell therapy, Bispecific antibody, Bridging therapy, Holding therapy, CD20xCD3, Relapsed refractory lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Study start
- Sep 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 20 Oct 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.
This prospective, single-center, open-label study evaluates a short course of CD20×CD3 bispecific antibody-based holding or bridging therapy before CD19-directed CAR T-cell therapy in adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
Participants will receive a CD20×CD3 bispecific antibody in combination with either GemOx or polatuzumab vedotin. Treatment assignment is based on prior therapy. The study will evaluate the antitumor activity and safety of this strategy, the proportion of patients who are able to proceed to planned CAR T-cell therapy, and clinical outcomes after CAR T-cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD20xCD3 Bispecific Antibody + Polatuzumab Vedotin | Experimental | Drug: Glofitamab, Drug: Epcoritamab, Drug: Polatuzumab Vedotin, Drug: ObinutuzumabParticipants with prior platinum-containing therapy will receive a CD20xCD3 bispecific antibody (glofitamab or epcoritamab) in combination with polatuzumab vedotin as holding or bridging therapy before planned CD19-directed CAR T-cell therapy. |
| CD20xCD3 Bispecific Antibody + GemOx | Experimental | Drug: Glofitamab, Drug: Epcoritamab, Drug: Gemcitabine & oxaliplatin, Drug: ObinutuzumabParticipants without prior platinum-containing therapy will receive a CD20xCD3 bispecific antibody (glofitamab or epcoritamab) in combination with GemOx as holding or bridging therapy before planned CD19-directed CAR T-cell therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 years or older.
- Ability to understand the study requirements and provide written informed consent.
- Histologically confirmed relapsed or refractory aggressive mature B-cell non-Hodgkin lymphoma.
- Failure of at least one prior line of systemic anticancer therapy.
- Documented CD19 expression on tumor cells by immunohistochemistry and/or flow cytometry/immunophenotyping of current disease.
Key exclusion criteria (14 listed)
- Prior treatment with a CD20×CD3 bispecific antibody.
- Absence of confirmed CD19 expression on tumor cells.
- No indication for, or any contraindication to, CD19-directed CAR T-cell therapy.
- ECOG performance status ≥3.
- Uncontrolled bacterial, viral, fungal, or opportunistic infection, including sepsis.
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 |
|---|---|---|
| GlofitamabGlofitamab administered according to the protocol-specified step-up dosing schedule, followed by two full doses in combination with either polatuzumab vedotin or GemOx. | Drug | CD20xCD3 Bispecific Antibody + GemOx, CD20xCD3 Bispecific Antibody + Polatuzumab Vedotin |
| EpcoritamabEpcoritamab administered according to the protocol-specified step-up dosing schedule, followed by two full doses in combination with either polatuzumab vedotin or GemOx. | Drug | CD20xCD3 Bispecific Antibody + GemOx, CD20xCD3 Bispecific Antibody + Polatuzumab Vedotin |
| Polatuzumab VedotinPolatuzumab vedotin 1.8 mg/kg administered intravenously once per cycle for two cycles in combination with the protocol-specified CD20xCD3 bispecific antibody. | Drug | CD20xCD3 Bispecific Antibody + Polatuzumab Vedotin |
| Gemcitabine & oxaliplatinGemcitabine 1000 mg/m² and oxaliplatin 100 mg/m² administered intravenously once every 21 days for two cycles in combination with the protocol-specified CD20xCD3 bispecific antibody. | Drug | CD20xCD3 Bispecific Antibody + GemOx |
| ObinutuzumabObinutuzumab 1000 mg administered intravenously as protocol-specified pretreatment before initiation of glofitamab step-up dosing. | Drug | CD20xCD3 Bispecific Antibody + GemOx, CD20xCD3 Bispecific Antibody + Polatuzumab Vedotin |
Primary outcome
Objective Response Rate After Two Cycles of Holding/Bridging Therapy
Time frame: 14 to 21 days after completion of the second 21-day combination cycle, before leukapheresis in the holding pathway or before lymphodepletion in the bridging pathway.
Proportion of participants achieving a complete or partial metabolic response according to Lugano 2014 criteria using the Deauville 5-point scale.
6 secondary outcomes
Proportion of Participants Receiving CAR T-Cell Infusion
Time frame: Assessed at the time of planned CAR T-cell infusion, following completion of holding/bridging therapy.
Incidence and Severity of Adverse Events During Holding/Bridging Therapy
Time frame: From the first dose of study treatment through the start of lymphodepletion, up to approximately 12 weeks
Safety of CAR T-Cell Therapy After Bispecific Antibody-Based Holding/Bridging Therapy
Time frame: From CAR T-cell infusion through Day +90; primary safety assessment through Day +28 with additional assessment through Day +90.
Objective Response Rate After CAR T-Cell Therapy
Time frame: Day +28 and Day +90 after CAR T-cell infusion
Event-Free Survival
Time frame: Up to 12 months after CAR T-cell infusion
Overall Survival
Time frame: Up to 12 months after CAR T-cell infusion
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.
- Individual participant dataSharing planned: No
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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.
Elena Parovichnikova, MD, DSc principal investigator
National Research Center for Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glofitamab, Epcoritamab and Polatuzumab Vedotin in people with Aggressive B-cell Non-Hodgkin Lymphoma (aNHL) and Relapsed or Refractory B-cell Lymphoma, run by National Research Center for Hematology, Russia at 1 site in Russia.
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 12 inclusion and 14 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 Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Runiza Abdurashidova, MD, PhD (+7 495 612-23-61, runiza.abdurashidova@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate After Two Cycles of Holding/Bridging Therapy (time frame: 14 to 21 days after completion of the second 21-day combination cycle, before leukapheresis in the holding pathway or before lymphodepletion in the bridging pathway.). 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.