Is NCT06191887 recruiting in Jacksonville, FL?

Yes, NCT06191887 is currently recruiting participants at its Jacksonville, FL location. This b-cell non-hodgkin lymphoma clinical trial is actively enrolling qualified participants.

How do I join the b-cell non-hodgkin lymphoma clinical trial in Jacksonville?

To join this clinical trial in Jacksonville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Jacksonville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

B-Cell Non-Hodgkin Lymphoma Clinical Trial in Jacksonville, FL

About This B-Cell Non-Hodgkin Lymphoma Study in Jacksonville

This phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BAFFR-based chimeric antigen receptor T-cells is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving chemotherapy, such as fludarabine and cyclophosphamide, helps ill cancer cells in the body and helps prepare the body to receive the BAFFR based chimeric antigen receptor T-cells. Giving BAFFR based chimeric antigen receptor T-cells with fludarabine and cyclophosphamide for lymphodepletion may work better for the treatment of patients with relapsed or refractory B-cell hematologic malignancies.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

PRE-REGISTRATION: Age ≥ 18 years

PRE-REGISTRATION: Confirmed diagnosis of 1 of the following relapsed or refractory B-cell hematologic malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or large B cell lymphoma (LBCL) including Richter's transformation from CLL/SLL

For CD19+ B cell malignancies; relapsed or refractory disease is defined by one of the following histopathology:

Biopsy proven SLL or flow cytometry proven CLL; relapsed or refractory disease is defined as:

Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or computed tomography (CT) criteria according to the international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria

Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease is defined as:

Demonstration of progressive or stable disease by PET/CT or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma

PRE-REGISTRATION: Disease Specific prior lines of therapies below:

For CLL/SLL, patients must have received ≥ two prior lines of therapy, and/or ≥ 6 months of second line prior BTK inhibition (e.g. ibrutinib or other such as acalabrutinib or zanubrutinib) and must have failed to respond to venetoclax or be intolerant. Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cγ2) may be included even if on ibrutinib therapy for less than 6 months

These patients may or may not have received prior antibody directed against cluster of differentiation 20 (CD20).

For Follicular Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.

NOTE: Prior cluster of differentiation 19 (CD19) directed chimeric antigen receptor T-cell therapy (CART) must have a 100-day washout period.

For Mantle Cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20, and a BTK inhibitor.

NOTE: Prior CD19 directed CART must have a 100-day washout period.

For Marginal Zone Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.

NOTE: Prior CD19 directed CART must have a 100-day washout period.

For Large B cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20. Prior exposure to CD19 directed CART will be allowed at the discretion of the Principal Investigator.

NOTE: Prior failed CD19 directed CART must have a 100-day washout period

For Richter's Transformation, patients must have received ≥two prior lines of therapy, including an antibody directed against CD20.

100-day washout period starts from the date of the last prior CAR-T infusion.

PRE-REGISTRATION: Measurable disease

REGISTRATION: Positive BAFFR test

REGISTRATION: Measurable disease

REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

REGISTRATION: Hemoglobin ≥ 9.0 g/dL (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration

REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration

REGISTRATION: Platelet count ≥100,000/mm\^3 (unless due to documented marrow involvement with disease) obtained ≤ 14 days prior to registration

REGISTRATION: Total bilirubin ≤ 1.5 x upper limits of normal (ULN) (Subjects with Gilbert's Syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) obtained ≤ 14 days prior to registration

REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) obtained ≤ 14 days prior to registration

REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR) /activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy obtained ≤ 14 days prior to registration

Patients on a stable, maintenance regimen of anticoagulant therapy for ≥ 30 days prior to registration may have PT/INR measurements \> 1.5 X ULN if, in the judgment of the investigator, the patient is suitable for the study

REGISTRATION: Calculated creatinine clearance ≥45 ml/min using the Cockcroft-Gault formula obtained ≤ 14 days prior to registration

REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

REGISTRATION: Provide written informed consent understand and comply with protocol-required study procedures

REGISTARTION: Patients must have an ejection fraction (EF) of ≥ 45%

REGISTRATION: Patients must have pulse ox measurements of \> 92% on room air

REGISTRATION: Willingness to provide mandatory blood specimens for correlative research

REGISTRATION: Willing to return to enrolling institution for study follow-up

Exclusion Criteria

PRE-REGISTRATION: Prior solid organ transplantation

PRE-REGISTRATION: Unstable angina, clinically significant arrhythmia, or myocardial infarction ≤ 6 months of prior to pre-registration, or grade 3 or higher pericardial effusion at the time of pre-registration

PRE-REGISTRATION: Prior anti-BAFF-R therapies

PRE-REGISTRATION: Known contraindication to lymphodepleting (LD) chemotherapy

PRE-REGISTRATION: Use of systemic antitumor therapy or investigational agent ≤ 14 days, prior to pre-registration

PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the BAFF-R

PRE-REGISTRATION: Autologous HCT ≤ 60 days prior to pre-registration

PRE-REGISTRATION: Uncontrolled intercurrent non-cardiac illness including, but not limited to:

Previous or concurrent malignancy

Ongoing or active infection

Psychiatric illness/social situations

Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy \

Persons of childbearing potential who are pregnant or breastfeeding

Life Expectancy of \< 6 weeks

Persons requiring systemic corticosteroids (\>10 mg prednisone or equivalent per day) and/or other immunosuppressive therapy. Patients are allowed to use topical corticosteroids

Any other conditions that would limit compliance with study requirements

PRE-REGISTRATION: Detectable malignant cells from cerebrospinal fluid (CSF) or magnetic resonance imaging (MRI) indicating brain metastases during screening, or a history of central nervous system (CNS) involvement by malignancy (CSF or imaging) with still active disease. Note: Patients with a history of CNS involvement resolving after treatment and without active disease will be considered eligible if other inclusion criteria are met

PRE-REGISTRATION: History of a seizure disorder, major cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

PRE-REGISTRATION: Radiation therapy ≤ 14 days prior to pre-registration

PRE-REGISTRATION: Prior allogeneic hematopoietic stem cell transplant (HCT) in ≤ 6 months prior to pre-registration; patients with active graft versus host disease (GVHD) will not be eligible regardless of duration from prior allogeneic HCT

PRE-REGISTRATION: Human immunodeficiency virus (HIV) positive patients

PRE-REGISTRATION: Subjects with New York Health Association (NYHA) class III or greater heart failure

REGISTRATION: Eligible for auto-HCT based on investigator judgement

REGISTRATION: Presence of active bacterial, viral, or fungal infection that is uncontrolled, based on investigator judgment

REGISTRATION: Patients with active hepatitis B or hepatitis C infections are excluded from the study. Patients who are documented to be HIV positive or proven HIV infection from testing are ineligible for the study. Infectious disease testing (HIV-1, HIV-2, hepatitis C virus (HCV) antibody and polymerase chain reaction (PCR), hepatitis B virus (HBV) surface antigen, HBV surface antibody, HBV core antibody) performed ≤ 45 days prior to registration may be considered for subject eligibility

REGISTRATION: Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥ 5 years prior to registration

REGISTRATION: Persons of childbearing potential who are pregnant or breastfeeding

REGISTRATION: Life expectancy of \< 6 weeks

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Yes, this clinical trial (NCT06191887) has an active research site in Jacksonville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

B-Cell Non-Hodgkin Lymphoma Treatment Options in Jacksonville, FL

If you're searching for b-cell non-hodgkin lymphoma treatment options in Jacksonville, FL, this clinical trial (NCT06191887) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced b-cell non-hodgkin lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all b-cell non-hodgkin lymphoma clinical trials near you to find additional studies recruiting in your area.

B-Cell Non-Hodgkin Lymphoma Clinical Trial in Jacksonville, FL

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