Is NCT05432635 recruiting in Duarte, CA?

Yes, NCT05432635 is currently recruiting participants at its Duarte, CA 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 Duarte?

To join this clinical trial in Duarte, 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 Duarte 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 Duarte, CA

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

This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are 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 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. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative.

Assent, when appropriate, will be obtained per institutional guidelines

Agreement to allow the use of archival tissue from diagnostic tumor biopsies.

If unavailable, exceptions may be granted with study PI approval

Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed

Age \>= 18 years

Karnofsky performance status (KPS) \>= 70

Life expectancy \>= 16 weeks at the time of enrollment

Patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma \[DLBCL\], mantle cell lymphoma \[MCL\], or transformed NHL) in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy

Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy

No known contraindications to myeloablative HSCT, leukapheresis, steroids or tocilizumab, smallpox vaccine and any other modified vaccinia Ankara (MVA)-based vaccines

Patient must be CMV seropositive

Total serum bilirubin =\< 2.0 mg/dL

Participants with Gilbert syndrome may be included if their total bilirubin is =\< 3.0

Aspartate aminotransferase (AST) \< 2.5 x upper limits of normal (ULN)

Alanine aminotransferase (ALT) \< 2.5 x ULN

Serum creatinine =\< 2.5 x ULN or estimated creatinine clearance of \>= 40 mL/min per the Cockcroft-Gault formula, and the participant is not on hemodialysis

Absolute neutrophil count \>= 1000/uL (Transfusions and growth factors must not be used to meet this requirement at initial screening)

Hemoglobin (Hb) \>= 8 g/dl (Transfusions and growth factors must not be used to meet this requirement at initial screening)

Platelet count \>= 50,000/uL (\>= 30,000/uL if bone marrow plasma cells are =\> 50 percent of cellularity) (Transfusions and growth factors must not be used to meet this requirement at initial screening)

Left ventricular ejection fraction \>= 45 percent within 8 weeks before enrollment

Oxygen (O2) saturation \> 92% without requiring supplemental oxygen

Women of childbearing potential (WOCBP): negative urine or serum pregnancy test

If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy.

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion Criteria

Prior autologous/allogeneic stem cell transplant

Growth factors within 14 days of enrollment

Platelet transfusions within 7 days of enrollment

Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\< 5 mg /day, or equivalent doses of other corticosteroids) is allowed

Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed

Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy

Any standard contraindications to myeloablative HSCT per standard of care practices at COH

Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening

Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any other active CNS disease. Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\< 5 white blood cells \[WBC\] / mm\^3 and no blasts in cerebrospinal fluid \[CSF\]) will be eligible

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab

Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia

History of stroke or intracranial hemorrhage within 6 months prior to screening

History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \>= 3 years.

Clinically significant uncontrolled illness

Active infection requiring antibiotics

Immunodeficiency virus (human immunodeficiency virus \[HIV\]) positive

Active viral hepatitis

Females only: Pregnant or breastfeeding

Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures

Procedures (including compliance issues related to feasibility/logistics). Prospective participants who, in the opinion of the investigator, may not be able to comply with all study

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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 Duarte?

Yes, this clinical trial (NCT05432635) has an active research site in Duarte, CA 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 Duarte, CA

If you're searching for b-cell non-hodgkin lymphoma treatment options in Duarte, CA, this clinical trial (NCT05432635) 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 Duarte 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 Duarte, CA

Expert Care in Duarte

IRB Approved

No-Cost Care

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