CORAL Study: Loncastuximab Tesirine and Rituximab Before CAR-T for Lymphoma
This study, called CORAL, is looking at whether giving two drugs, Loncastuximab Tesirine and Rituximab, is safe and works well as a "bridging therapy" before standard CAR-T cell therapy for people with large B-cell lymphoma that has come back or not responded to previous treatments. You might be able to join if you are at least 18 years old, have this type of lymphoma, and your doctor thinks you need bridging therapy before CAR-T. The researchers will know if the treatment is successful by looking at how many people have a complete response to CAR-T therapy about one month later, and by checking for side effects like low blood counts (cytopenias) during that same time. The study is currently unclear on its recruitment status and plans to enroll 29 participants.
- Study design
- This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 29 participants.
- What's involved
- You would receive Loncastuximab Tesirine and Rituximab intravenously for 1 to 6 cycles, with each cycle lasting 21 days, before your standard CAR-T cell therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes like complete response and severity of low blood counts about one month after CAR-T administration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06788964
Loncastuximab Tesirine and Rituximab as Bridging Therapy Before Standard-of-care CAR-T Therapy in Patients With Large B-cell Lymphoma (CORAL)
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of UtahInvestigator-initiated
~29 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Loncastuximab TesirineRituximab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The complete response (CR) rate at D30 post CAR-T(+/- 7 days) post CAR-T administration per Lugano 2014 criteria.
Measured over 1 month
+3 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesUtah1
Study leadership
- Narendranath Epperla, MD, MS, FACP · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Hepatic:
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
Renal:
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
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.
What this trial measures
- The complete response (CR) rate at D30 post CAR-T(+/- 7 days) post CAR-T administration per Lugano 2014 criteria.1 month
To evaluate the efficacy of SOC CAR T-cell therapy in patients with R/R large B-cell lymphoma following bridging with lonca-R.
- Duration of cytopenias post CAR-T (as defined by the NIH CTCAE, version 5.0) D30 post CAR-T (+/- 7 days).1 month
To evaluate toxicities post CAR-T
- Severity of cytopenias post CAR-T (as defined by the NIH CTCAE, version 5.0) D30 (+/- 7 days).1 month
To evaluate toxicities post CAR-T
- Rate of infections D30 (+/- 7 days).1 month
To evaluate toxicities post CAR-T