Follicular LymphomaPhase 1NCT05934838
A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas
A Phase 1 study testing Tazemetostat Pill in people with Follicular Lymphoma and B-Cell Lymphoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a clinical trial to evaluate the feasibility and safety of giving tazemetostat followed by standard of care CAR T cell infusion in previously treated diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, B-Cell Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Tazemetostat Pill
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to Sep 2031
- 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
- Confirmed diagnosis of DLBCL, FL, or MCL
- Eligible to receive standard of care CAR T cells
- Have received at least 1 prior therapies
Who cannot join
- Active viral infection with HIV or hepatitis type B or C
- Active, uncontrolled systemic fungal, bacterial or viral infection
- Active treatment for another cancer
- Pregnant or breastfeeding
- Unable to take oral medication
- Certain significant past medical history, such recent stroke, pulmonary embolism, myocardial infarction, congestive heart failure, uncontrolled hypertension, or certain arrhythmias
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10065
About this study
This is a clinical trial to evaluate the feasibility and safety of giving tazemetostat followed by standard of care CAR T cell infusion in previously treated diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). The investigators hypothesis is that this combination has the potential to significantly improve the ability of CART cells to recognize and kill lymphoma cells without a significant impact on safety. Participants will receive the tazemetostat pills before and after receiving their CAR T cell therapy, for up to 12 months after CAR T cell administration. Patients will be followed for up to 5 years.
Read the detailed description
This is a single arm, open label, clinical trial to evaluate the feasibility and safety of oral tazemetostat followed by standard of care CAR T cell infusion in previously treated DLBCL, FL, and MCL. The investigators hypothesis is that this combination has the potential to significantly improve the ability of CART cells to recognize and kill lymphoma cells without a significant impact on safety.
Tazemetostat 800 mg will be given twice daily by mouth for at least 1 week prior to apheresis, during the period between apheresis and CAR T infusion, and following lymphodepletion chemotherapy until Day 7 post-CAR T therapy. Once patients' platelets and neutrophil counts recover, tazemetostat will be resumed. Tazemetostat treatment will continue for up to 6 months in patients with complete responses and up to 12 months in patients with partial responses.
A 3+3 trial design will be implemented for the first six patients enrolled. The regimen will be considered feasible if at least 12 out of 15 subjects are able to receive at least 2 weeks of tazemetostat, generate the CAR T cell product and receive CAR T cell therapy.
- Being tested
- Tazemetostat Pill
- Keywords
- CAR T-cell, Tazemetostat, FL, MCL, DLBCL
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tazemetostat PillDrug
Also called Tazverik
Participants will take 800 mg of tazemetostat twice a day starting 7 days before apheresis and continue to take tazemetostat until lymphodepletion, which is chemotherapy given prior to receiving the CAR T cells. Participants will stop taking tazemetostat after lymphodepletion until after CAR T cell infusion. Once lymphocyte counts increase, tazemetostat will be resumed and tazemetostat will be taken for 6 - 12 months, depending on participant response.
| Study group | Role | What they receive |
|---|---|---|
| Tazemetostat and CAR T-Cell Therapy | Experimental | Tazemetostat is being administered prior to, and following, standard of care CAR T cell therapy. The use of tazemetostat in this way is investigational. Receives: Drug: Tazemetostat Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience adverse events classified per CTCAEv5
Adverse reactions will be graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: From start of treatment until 30 days after the last dose of tazemetostat, for a maximum of approximately 13 months
Secondary outcomes (5)
Number of patients who experience cytokine release syndrome (CRS) by ASTCT Consensus Grading system during therapy
Patients will undergo screening for CRS per American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
Measured: From start of treatment until Day 21 days following CAR T cell infusion
Number of patients who experience immune effector cell neurotoxicity syndrome (ICANS) by ASTCT Consensus Grading system during therapy
Patients will undergo screening for ICANS per American Society for Transplantation and Cellular Therapy (ASTCT) guidelines
Measured: From start of treatment until Day 21 days following CAR T cell infusion
Overall response rate (ORR) reported as per Lugano response criteria
Overall response rate will be reported as the number of participants who achieve a complete or partial response per the Lugano response criteria
Measured: From start of treatment until disease progression or death, for a maximum of approximately 6 years
Mean Progression-Free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of documentation of progression or death from any cause.
Measured: From start of treatment until disease progression or death, for a maximum of approximately 6 years
Mean Overall Survival (OS)
OS is defined as the duration of time from start of treatment to death from any cause.
Measured: From start of treatment until death, for a maximum of approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start4 Oct 2023
- Primary completion30 May 2026
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Epizyme, Inc., Applebaum Foundation, American Society of Clinical Oncology
- Responsible party
- Sponsor
- Investigators
- Caitlin K Gribbin, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934838
- Sponsor's protocol ID
- 22-07025095
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas
- ClinicalTrials.gov ID
- NCT05934838
- Acronym / sponsor ID
- 22-07025095
- Keywords
- CAR T-cell, Tazemetostat, FL, MCL, DLBCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Epizyme, Inc., Applebaum Foundation, American Society of Clinical Oncology
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- Sep 2031 (estimated)
- First posted
- 7 Jul 2023 (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 is a clinical trial to evaluate the feasibility and safety of giving tazemetostat followed by standard of care CAR T cell infusion in previously treated diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). The investigators hypothesis is that this combination has the potential to significantly improve the ability of CART cells to recognize and kill lymphoma cells without a significant impact on safety. Participants will receive the tazemetostat pills before and after receiving their CAR T cell therapy, for up to 12 months after CAR T cell administration. Patients will be followed for up to 5 years.
Detailed description
This is a single arm, open label, clinical trial to evaluate the feasibility and safety of oral tazemetostat followed by standard of care CAR T cell infusion in previously treated DLBCL, FL, and MCL. The investigators hypothesis is that this combination has the potential to significantly improve the ability of CART cells to recognize and kill lymphoma cells without a significant impact on safety.
Tazemetostat 800 mg will be given twice daily by mouth for at least 1 week prior to apheresis, during the period between apheresis and CAR T infusion, and following lymphodepletion chemotherapy until Day 7 post-CAR T therapy. Once patients' platelets and neutrophil counts recover, tazemetostat will be resumed. Tazemetostat treatment will continue for up to 6 months in patients with complete responses and up to 12 months in patients with partial responses.
A 3+3 trial design will be implemented for the first six patients enrolled. The regimen will be considered feasible if at least 12 out of 15 subjects are able to receive at least 2 weeks of tazemetostat, generate the CAR T cell product and receive CAR T cell therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tazemetostat and CAR T-Cell Therapy | Experimental | Drug: Tazemetostat PillTazemetostat is being administered prior to, and following, standard of care CAR T cell therapy. The use of tazemetostat in this way is investigational. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of DLBCL, FL, or MCL
- Eligible to receive standard of care CAR T cells
- Have received at least 1 prior therapies
Key exclusion criteria (6 listed)
- Active viral infection with HIV or hepatitis type B or C
- Active, uncontrolled systemic fungal, bacterial or viral infection
- Active treatment for another cancer
- Pregnant or breastfeeding
- Unable to take oral medication
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 |
|---|---|---|
| Tazemetostat PillAlso: TazverikParticipants will take 800 mg of tazemetostat twice a day starting 7 days before apheresis and continue to take tazemetostat until lymphodepletion, which is chemotherapy given prior to receiving the CAR T cells. Participants will stop taking tazemetostat after lymphodepletion until after CAR T cell infusion. Once lymphocyte counts increase, tazemetostat will be resumed and tazemetostat will be taken for 6 - 12 months, depending on participant response. | Drug | Tazemetostat and CAR T-Cell Therapy |
Primary outcome
Number of participants who experience adverse events classified per CTCAEv5
Time frame: From start of treatment until 30 days after the last dose of tazemetostat, for a maximum of approximately 13 months
Adverse reactions will be graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
5 secondary outcomes
Number of patients who experience cytokine release syndrome (CRS) by ASTCT Consensus Grading system during therapy
Time frame: From start of treatment until Day 21 days following CAR T cell infusion
Number of patients who experience immune effector cell neurotoxicity syndrome (ICANS) by ASTCT Consensus Grading system during therapy
Time frame: From start of treatment until Day 21 days following CAR T cell infusion
Overall response rate (ORR) reported as per Lugano response criteria
Time frame: From start of treatment until disease progression or death, for a maximum of approximately 6 years
Mean Progression-Free Survival (PFS)
Time frame: From start of treatment until disease progression or death, for a maximum of approximately 6 years
Mean Overall Survival (OS)
Time frame: From start of treatment until death, for a maximum of approximately 6 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 17 Jun 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. This study is not recruiting at the moment.
Caitlin K Gribbin, M.D. principal investigator
Weill Medical College of Cornell University
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 Tazemetostat Pill in people with Follicular Lymphoma and B-Cell Lymphoma, run by Weill Medical College of Cornell University 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 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?
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?
Number of participants who experience adverse events classified per CTCAEv5 (time frame: From start of treatment until 30 days after the last dose of tazemetostat, for a maximum of approximately 13 months). 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 17 Jun 2026.