Salt Lake City, UTNCT06788964Now EnrollingIRB Ready

Relapsed or Refractory Large B-cell Lymphoma Clinical Trial in Salt Lake City, UT

Access cutting-edge relapsed or refractory large b-cell lymphoma treatment through this clinical trial at a research site in Salt Lake City. Study-provided care at no cost to qualified participants.

Sponsored by University of Utah

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Expert Care in Salt Lake City

Access relapsed or refractory large b-cell lymphoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related relapsed or refractory large b-cell lymphoma treatment provided free

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Check if you qualify for this relapsed or refractory large b-cell lymphoma clinical trial in Salt Lake City, UT

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Why Participate?

  • No-Cost Study Care

  • Local to Salt Lake City

    Convenient for UT residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Salt Lake City site if eligible
  4. 4Begin participation

About This Relapsed or Refractory Large B-cell Lymphoma Study in Salt Lake City

The purpose of this clinical trial is to learn if the study treatment Loncastuximab tesirine and Rituximab is safe and efficient before standard of care chimeric antigen receptor T-cell (CAR-T) therapy in patients with relapsed or refractory large B-cell lymphoma.

Sponsor: University of Utah

Who Can Participate

Inclusion Criteria

Subject aged ≥ 18 years.
Intended to receive commercial CD19-directed CAR-T cell therapy (axi-cel and liso-cel).
Need for bridging therapy as deemed clinically necessary by the treating physician.
Relapsed or refractory DLBCL, tFL or PMBCL as defined by the 2016 World Health Organization classification (including patients with DLBCL transformed from indolent lymphoma), or high-grade B-cell lymphoma (HGBL), not otherwise specified, and HGBL with MYC and BCL2 and/or BCL6 rearrangements. --Relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) disease following at least one multi-agent systemic treatment regimen.
Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening PET-CT.
ECOG Performance Status ≤ 2.
Time between prior anticancer therapy and first dose of lonca-R as below
Autologous hematopoietic cell transplantation - At least 30 days
Allogeneic hematopoietic cell transplantation - At least 60 days
Cytotoxic chemotherapy - At least 21 days
Non-cytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days
Adequate organ function as defined as:
Hematologic:
Absolute neutrophil count (ANC) ≥ 1000/mm3
Platelet count ≥ 75,000/mm3
Hemoglobin ≥ 8 g/dL
Bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN with document liver involvement and/ or Gilbert's disease
Transaminases (AST or ALT) ≤ 3 x ULN or ≤ 5 x ULN with documented liver involvement
Estimated creatinine clearance ≥ 60 mL/min by Cockcroft-Gault formula.
For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
Women \< 50 years of age:
Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥ 50 years of age:
Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
Had radiation-induced menopause with last menses \>1 year ago; or
Had chemotherapy-induced menopause with last menses \>1 year ago; or
Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and the lactation requirements as described in Sections 5.41.1 and 5.4.2.
Subjects or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.
Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria

Previous treatment with any anti-CD19 therapy including lonca or prior CD19 CAR T-cell therapy
Subjects receiving investigational CAR-T products
Major surgery within 4 weeks prior to starting study therapy.
History of bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.
Subjects with chronic liver disease with hepatic impairment Child-Pugh class C
Pregnant or lactating or intending to become pregnant during the study
Active graft-versus-host disease
Post-transplantation lymphoproliferative disorders
Active autoimmune disease which, in the opinion of the investigator, may negatively impact subject safety or interfere with study participation.
The diagnosis of another malignancy which, in the opinion of the investigator, is likely to negatively impact subject safety or interfere with study participation.
Subjects with known CNS involvement.
Significant medical diseases or conditions including those requiring substantial changes in concomitant medications, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to the following conditions:
Cardiovascular disorders:
Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
Myocardial infarction (MI) within 6 months before the first dose.
QTc prolongation defined as a QTcF \> 480 ms.
Congenital long QT syndrome or a corrected QT measure (QTc) interval of \>480 ms at screening (unless secondary to pacemaker or bundle branch block).
Severe pulmonary disease
Uncontrolled diabetes mellitus
Severely immunocompromised state
Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening
HIV infection.
Subjects with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Subjects who are Hepatitis B core antibody positive must take prophylaxis with entecavir or equivalent and be willing to undergo monthly Hepatitis B DNA PCR testing. Subjects with active Hep C patients may be enrolled if other parameters precluding hepatic impairment are met and they are not undergoing active therapy for hepatitis C.
Known prior severe hypersensitivity to a CD19 antibody, lonca (including SG3249) or any of its excipients, or history of positive serum human ADA to a CD19 antibody.
Subjects taking prohibited medications as described in Section 6.8.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.

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 Salt Lake City?

Yes, this clinical trial (NCT06788964) has an active research site in Salt Lake City, UT 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.

Relapsed or Refractory Large B-cell Lymphoma Treatment Options in Salt Lake City, UT

If you're searching for relapsed or refractory large b-cell lymphoma treatment options in Salt Lake City, UT, this clinical trial (NCT06788964) 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 Salt Lake City research site is actively enrolling participants for this clinical trial. You'll receive care from experienced relapsed or refractory large b-cell 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 relapsed or refractory large b-cell lymphoma clinical trials near you to find additional studies recruiting in your area.

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