Is NCT05625594 recruiting in Duarte, CA?

Yes, NCT05625594 is currently recruiting participants at its Duarte, CA location. This central nervous system lymphoma clinical trial is actively enrolling qualified participants.

How do I join the central nervous system 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.

Central Nervous System Lymphoma Clinical Trial in Duarte, CA

About This Central Nervous System Lymphoma Study in Duarte

This phase I trial tests the safety, side effects, and best dose of intracerebroventricularly (ICV) administered CD19-chimeric antigen receptor (CAR) T cells in treating patients with central nervous system (CNS) lymphoma. CAR T cell therapy 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, CD19, 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. ICV is an injection technique that delivers the CD19-CAR T cells directly into the cerebrospinal fluid (which flows in and around the hollow spaces of the brain and spinal cord, and the thin layers of tissue that cover and protect the brain and spinal cord) in the brain, through a surgically placed catheter. Giving CD19-CAR T cells ICV may be more effective at treating patients with CNS lymphoma than giving them via other methods.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Participant must have the ability to understand and the willingness to sign a written informed consent

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. However, the research participant can proceed with lymphodepletion (if applicable) and CAR T cell infusion only after the translated full consent form is signed

Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable exceptions may be granted with study principal investigator (PI) approval

Age \>= 18 years

Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Documented primary CNS lymphoma. Progression must be determined radiographically. Participant must have measurable disease which could be a measurable lymphomatous mass or, in the case of leptomeningeal only disease, measurable lymphoma cells in CSF by flow cytometry

Patients with secondary CNS lymphoma with CNS only relapse, confirmed by PET-CT, may also be eligible, per PI discretion.

Documented current CD19+ tumor expression if prior CD19 directed therapy was used

Participant must have received and failed or have been intolerant to CNS directed therapy like high dose methotrexate or high dose cytarabine based regimens. Participants are not required to have failed all of these agents if, in the investigator's opinion, they would benefit from treatment on the current protocol

Prior CAR T cell therapy is allowed if at least 3 months have elapsed prior to leukapheresis procedure

If participant received prior CD19-CAR T cells persistence must be evaluated and found to be \<5% prior to leukapheresis procedure

No known contraindications to leukapheresis, steroids or tocilizumab

Participant of reproductive potential must agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment

Total serum bilirubin =\< 2.0 mg/dL (within 14 days of signing the screening and leukapheresis consent)

Patients with Gilbert syndrome may be included if their total bilirubin is =\< 3.0 x upper limit of normal (ULN) and direct bilirubin =\< 1.5 x ULN

Aspartate aminotransferase (AST) =\< 2.5 x ULN (within 14 days of signing the screening and leukapheresis consent)

Alanine aminotransferase (ALT) =\< 2.5 x ULN (within 14 days of signing the screening and leukapheresis consent)

Creatinine clearance of \>= 50 mL/min per the Cockcroft-Gault formula (within 14 days of signing the screening and leukapheresis consent)

Cardiac function (12 lead-electrocardiogram \[ECG\]) without acute abnormalities requiring investigation or intervention (within 14 days of signing the screening and leukapheresis consent)

Absolute neutrophil count \>= 750/uL (within 14 days of signing the screening and leukapheresis consent)

Hemoglobin (Hb) \>= 8 g/dl (within 14 days of signing the screening and leukapheresis consent)

Platelet count \>= 50,000/uL (within 14 days of signing the screening and leukapheresis consent)

Ejection fraction measured by echocardiogram or multigated acquisition scan (MUGA) \> 40% (evaluation within 6 weeks of screening does not need to be repeated) (within 14 days of signing the screening and leukapheresis consent)

Oxygen (O2) saturation \> 92% not requiring oxygen supplementation (within 14 days of signing the screening and leukapheresis consent)

Seronegative for HIV qPCR, HCV\*, active HBV (Surface Antigen Negative), and syphilis (RPR)

If positive, Hepatitis C RNA quantitation must be performed. OR

If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable. Meets other institutional and federal requirements for infectious disease titer requirements Note Infectious disease testing to be performed within 28 days prior to enrollment.

Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days of signing the screening and leukapheresis consent)

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

Exclusion Criteria

Participant has not yet recovered from toxicities of prior therapy

Presence of systemic lymphoma

Participant with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the screening and leukapheresis consent

Participant with known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder

Active autoimmune disease requiring systemic immunosuppressive therapy

Needing dexamethasone more than 4mg/day (or equivalent) within 72 hours prior to leukapheresis or CAR T cell infusion

History of allergic reactions attributed to compounds of similar chemical or biologic composition or other agents used in this study

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

History of stroke or intracranial hemorrhage within 6 months prior to signing the screening and leukapheresis consent

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

Uncontrolled active infection

Active hepatitis B or hepatitis C infection: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded

Subjects who are hepatitis B core antibody positive (or have a known history of hepatitis B virus \[HBV\] infection) should be monitored quarterly with a quantitative PCR test for HBV deoxyribonucleic acid (DNA). HBV monitoring should last until 12 months after last dose of study drug. Any subject with a rising viral load (above lower limit of detection) should discontinue study drug and have antiviral therapy instituted and a consultation with a physician with expertise in managing hepatitis B. Subjects who are core antibody (Ab) positive at study enrollment are strongly recommended to start Entecavir before start and until completion of study treatment

Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded

Human immunodeficiency virus (HIV) infection

Active significant bacterial, fungal or viral (other than those listed) infections

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

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 (NCT05625594) 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.

Central Nervous System Lymphoma Treatment Options in Duarte, CA

If you're searching for central nervous system lymphoma treatment options in Duarte, CA, this clinical trial (NCT05625594) 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 central nervous system 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 central nervous system lymphoma clinical trials near you to find additional studies recruiting in your area.

Central Nervous System Lymphoma Clinical Trial in Duarte, CA

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