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Trial Title:
A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas
NCT ID:
NCT05934838
Condition:
Follicular Lymphoma
B-Cell Lymphoma
Mantle Cell Lymphoma
Diffuse Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
CAR T-cell
Tazemetostat
FL
MCL
DLBCL
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tazemetostat Pill
Description:
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.
Arm group label:
Tazemetostat and CAR T-Cell Therapy
Other name:
Tazverik
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). 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Confirmed diagnosis of DLBCL, FL, or MCL
- Eligible to receive standard of care CAR T cells
- Have received at least 1 prior therapies
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Weill Cornell Medicine/NewYork-Presbyterian Hospital
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nicole Santos
Phone:
646-962-6827
Email:
nis7058@med.cornell.edu
Contact backup:
Last name:
Samuel Yamshon, MD
Email:
sjy9001@med.cornell.edu
Investigator:
Last name:
Samuel Yamshon, M.D.
Email:
Principal Investigator
Start date:
October 4, 2023
Completion date:
September 2031
Lead sponsor:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Collaborator:
Agency:
Epizyme, Inc.
Agency class:
Industry
Collaborator:
Agency:
Applebaum Foundation
Agency class:
Other
Collaborator:
Agency:
American Society of Clinical Oncology
Agency class:
Other
Source:
Weill Medical College of Cornell University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05934838
