Is NCT04892277 recruiting in Rochester, MN?

Yes, NCT04892277 is currently recruiting participants at its Rochester, MN location. This recurrent b-cell non-hodgkin lymphoma clinical trial is actively enrolling qualified participants.

Is participation in this Rochester 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.

Recurrent B-Cell Non-Hodgkin Lymphoma Clinical Trial in Rochester, MN

Q: How do I join the recurrent b-cell non-hodgkin lymphoma clinical trial in Rochester?

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

About This Recurrent B-Cell Non-Hodgkin Lymphoma Study in Rochester

This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19/1563 treatment. IC19/1563 may help treat patients with relapsed/refractory B cell malignancies.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age \>= 18 years

Relapsed or refractory CD19+ B cell malignancies of the one of the following histopathology:

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

Two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable. Exception: Patients with Richter transformation of CLL are eligible if they had \>= one prior treatment, including prior BTK inhibition

Demonstration of progressive or stable disease by positron emission tomography/computed tomography (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.

Measurable disease defined as measurable by CT portion of a PET/CT: To be considered measurable, the must be at least one lesion that has a single diameter of (\>1.5 cm Note: Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy

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

\>= two prior lines of therapy, and/or \>= 6 months of second line prior BTK inhibition (e.g. venetoclax and ibrutinib). Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cgamma2) may be included even if on ibrutinib therapy for less than 6 months.

Demonstration of progressive or stable disease by PET/CT or CT criteria according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL2018) criteria

Measurable disease by CT portion of a PET/CT where at least one lesion has a single diameter of \>1.5 cm or peripheral blood absolute blood lymphocyte count (ALC) of \> 5000. Note: Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Hemoglobin \>= 8.0 g/dL (=\< 14 days prior to registration)

Absolute neutrophil count (ANC) \>= 500/mm\^3 (=\< 14 days prior to registration)

Platelet count \>= 30,000/mm\^3 (=\< 14 days prior to registration)

Total bilirubin =\< 2.0 mg/dL (with the exception of subjects with Gilbert's syndrome. Subjects with Gilbert's syndrome may be included if their total bilirubin is =\< 3.0 x upper limit of normal (ULN) and direct bilirubin =\< 1.5 x ULN) (=\< 14 days prior to registration)

Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 14 days prior to registration)

Prothrombin time (PT) / international normalized ratio (INR) and/or 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 (for patients receiving anticoagulation, there should be no prior history of bleeding, and no recent deep venous thrombosis/pulmonary embolism (DVT/PE) within the last 6 months of enrollment) (=\< 14 days prior to registration)

Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (=\< 14 days prior to registration)

Cardiac ejection fraction \>= 50% and no evidence of clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition scan (MUGA) scan

Baseline oxygen saturation \>= 92% on room air

Negative serum pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only

Women patients of child bearing potential, including women with tubal ligations, must commit to using use 2 highly effective forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) for the duration of the study and for 12 months following IC19/1563 therapy

Provide written informed consent

Willingness to provide mandatory blood specimens for correlative research

Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Exclusion Criteria

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

Pregnant persons

Nursing persons

Women of childbearing potential who are unwilling to employ highly effective contraception

Sexually active males who are not willing to use contraception during the study and for \>= 12 months after IC19/1563 therapy

Patients who are able to obtain market approved CD19 CAR T-cell therapies

Live vaccine =\< 6 weeks prior to start of registration

Autologous stem cell transplant =\< 6 weeks of registration

History of allogenic stem cell transplant if was performed less than 100 days prior to registration, if patients have active graft-versus host disease (GVHD) or are if patients are on chronic immunosuppression. Patients with allogeneic transplantation more than 100 days prior to registration, with no active GVHD and who are not on immunosuppression are eligible

History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement

Any form of primary immunodeficiency such as severe combined immunodeficiency disease

Current need of systemic corticosteroid therapy, in doses over 20 mg /day of prednisone or equivalent forms of steroids

History of severe immediate hypersensitivity reaction to CART19, stem cell infusion dimethyl sulfoxide (DMSO) or any of the CAR-T cryopreservation ingredients

History of malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast) or early stage cancers (Stage I or II), unless disease free for \>= 2 years

Clinically significant active infection (e.g. simple urinary tract infection \[UTI\], bacterial pharyngitis allowed) or currently receiving IV antibiotics or have received IV antibiotics =\< 7 days prior to registration. Note: prophylactic antibiotics, antivirals and antifungals are permitted

Known history of human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or hepatitis C infection. Subjects with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines. Prophylactic antiviral therapy should be considered per institutional guidelines

History of any of the following cardiovascular conditions =\< 6 months:

Class III or IV heart failure as defined by the New York Heart Association (NYHA)

Cardiac angioplasty or stenting

Myocardial infarction

Unstable angina

Or other clinically significant cardiac disease

Any other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that, in the judgment of the investigator, would make the subject inappropriate for entry into the study

Concurrent cancer therapy. The following are exceptions:

Treatment with therapies may continue at time of registration; however, the washout period must be met prior to leukapheresis

Treatment with any other investigational agent may continue at time of registration provided last date of treatment is =\< 14 days prior to leukapheresis.

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 Rochester?

Yes, this clinical trial (NCT04892277) has an active research site in Rochester, MN 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.

Recurrent B-Cell Non-Hodgkin Lymphoma Treatment Options in Rochester, MN

If you're searching for recurrent b-cell non-hodgkin lymphoma treatment options in Rochester, MN, this clinical trial (NCT04892277) 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 Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent 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 recurrent b-cell non-hodgkin lymphoma clinical trials near you to find additional studies recruiting in your area.

Recurrent B-Cell Non-Hodgkin Lymphoma Clinical Trial in Rochester, MN

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