Is NCT04545762 recruiting in San Francisco, CA?

Yes, NCT04545762 is currently recruiting participants at its San Francisco, CA location. This refractory non-hodgkin lymphoma clinical trial is actively enrolling qualified participants.

Is participation in this San Francisco 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.

Refractory Non-Hodgkin Lymphoma Clinical Trial in San Francisco, CA

Q: How do I join the refractory non-hodgkin lymphoma clinical trial in San Francisco?

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

Who Can Participate

Inclusion Criteria

Dose expansion Cohorts: Cohort B (Burkitt):

Participants must have a diagnosis of relapsed or refractory Burkitt Lymphoma

Participants with Burkitt lymphoma must have relapsed or failed to respond to at least 1 prior line of multiagent chemoimmunotherapy with prior exposure to both an anti-CD20 antibody agent and an anthracycline.

No significant circulating disease, defined as an elevated total lymphocyte count above the upper limit of normal (ULN) due to the presence of malignant cells.

Participants must have measurable disease as defined below:

Participants with Burkitt Lymphoma must have Positron Emission Tomography (PET)-positive disease according to "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification" Cohort M/W (Marginal/Waldenström):

Participants must have a diagnosis of relapsed or refractory Marginal Zone Lymphoma (MZL), or Lymphoplasmacytic Lymphoma (LPL)/Waldenström Macroglobulinemia (WM): o Participants with indolent lymphomas (nodal or extranodal marginal zone lymphoma, and lymphoplasmacytic lymphoma) must have relapsed after or have been refractory to ≥ 2 prior lines of multi-agent chemoimmunotherapy including prior exposure to an anti-CD20 antibody and an alkylating agent.

Participants must have measurable disease as defined below: o Participants with Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia: must either have PET-positive disease according to "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification" or serum monoclonal immunoglobulin M (IgM) paraprotein \> 0.5 g/dL.

Participants with indolent lymphoma (Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma/Waldenström Macroglobulinemia) must have symptomatic disease or steady progression necessitating systemic treatment per investigator discretion. In addition, all participants must meet the following criteria:

CD19-positive by either immunohistochemistry or flow cytometry analysis on any biopsy. If prior anti-CD19 therapy has been administered, CD19-positivity has to be re-established on the most recent biopsy.

Age ≥18 years at the time of consent.

Absolute lymphocyte count \> 100/UL.

Eastern Cooperative Oncology Group (ECOG) performance status \< 2.

Adequate organ function, defined as:

Adequate bone marrow function for apheresis and lymphodepleting chemotherapy

Hemoglobin \>8 gm/dl (transfusions allowed)

Platelets \>50,000/uL (transfusions allowed)

Absolute Neutrophil Count (ANC) \> 500/uL

alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \< 3 x institutional upper limit of normal (ULN) and Total bilirubin \< 1.5 mg/dl x institutional ULN, except with Gilbert's syndrome

Serum Creatinine \< 2 x the institutional ULN

Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \> 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) within 3 months of screening. Repeat testing may occur at Investigator's discretion.

Adequate vascular access for leukapheresis procedure (either peripheral line or surgically placed line).

Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have a negative serum or urine pregnancy test AND agree to use highly effective methods of contraception for 1 year after the last dose of anti-CD19 CAR-T cells.

Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method.

Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

Autologous transplant within 6 weeks of planned CAR-T cell infusion.

Recipient of prior CAR-T cell therapy targeting CD19 outside of this protocol.

Active other malignancy, other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, or breast).

Human immunodeficiency virus (HIV) seropositivity.

Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded.)

Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. NOTE: Women of childbearing potential must have a negative serum or urine pregnancy test.

Participants with history of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.

History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.

Body weight \<40 kilograms(kg). Eligibility for Infusion of Investigational Product: Participants will undergo an evaluation of eligibility on day 1 prior to infusion of anti-CD19 CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions:

No significant laboratory abnormalities. Laboratory result abnormalities that are considered not clinically significant by the principal investigator AND are not the result of a demonstrated active infection or an active central nervous system condition.

ECOG performance status \< 2

No evidence of uncontrolled intercurrent illness including, but not limited to ongoing or active infection, inflammatory response, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations.

No new neurologic symptoms suggestive of an active central nervous system condition, or uncontrolled CNS involvement by lymphoma.

No corticosteroid use within 7 days prior to infusion (with exception of agents used for prevention of emesis during lymphodepletive chemotherapy).

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 San Francisco?

Yes, this clinical trial (NCT04545762) has an active research site in San Francisco, 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.

Refractory Non-Hodgkin Lymphoma Treatment Options in San Francisco, CA

If you're searching for refractory non-hodgkin lymphoma treatment options in San Francisco, CA, this clinical trial (NCT04545762) 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 San Francisco research site is actively enrolling participants for this clinical trial. You'll receive care from experienced refractory 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 refractory non-hodgkin lymphoma clinical trials near you to find additional studies recruiting in your area.

Refractory Non-Hodgkin Lymphoma Clinical Trial in San Francisco, CA

Expert Care in San Francisco

IRB Approved

No-Cost Care

Apply for This San Francisco Location

Why Participate?

Simple Process

About This Refractory Non-Hodgkin Lymphoma Study in San Francisco