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Monoclonal Antibodies

Loncastuximab Tesirine for B-Cell Lymphoma

Phase 2

Recruiting

Led By Stephen D. Smith

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Group 1: CD19+ relapsed/refractory post-transplant lymphoproliferative disorder (PTLD)

Blood creatinine =< 2.0 x ULN or calculated creatinine clearance >= 50 mL/min by the Cockcroft and Gault equation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests whether a targeted therapy drug shrinks tumors in patients with B-cell malignancies that have come back or does not respond to treatment.

Who is the study for?

Adults with certain B-cell malignancies that have returned or are treatment-resistant can join this trial. They must be over 18, in fairly good health (ECOG PS 0-2), and have normal-ish liver/blood tests. Specific groups include those with CD19+ lymphoma post-transplant, relapsed/refractory non-Hodgkin's excluding some types, or after CAR T-cell therapy/allogeneic transplant. Women/men of childbearing potential must agree to contraception.Check my eligibility

What is being tested?

The trial is testing Loncastuximab Tesirine for shrinking tumors in patients with B-cell malignancies that haven't responded to other treatments. It's a monoclonal antibody targeting CD19 receptors on cancer cells combined with a chemo drug to kill them.See study design

What are the potential side effects?

Possible side effects may include reactions at the infusion site, fatigue, nausea, fever, and low blood cell counts leading to increased infection risk. As it involves chemotherapy linked to an antibody, there might also be typical chemo-related side effects like hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My condition is CD19+ PTLD and it has come back or didn't respond after a transplant.

Select...

My kidney function, measured by creatinine levels or clearance, is within the required range.

Select...

I have a cancerous area or spleen enlargement that can be measured.

Select...

My B-cell NHL has come back or didn't respond to treatment and lacks CD19.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (ORR)

Secondary outcome measures

Clinical benefit rate

Duration or response

Incidence of grade 3-5 drug-related toxicity

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (loncastuximab tesirine)Experimental Treatment1 Intervention

Patients receive loncastuximab tesirine IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Loncastuximab tesirine

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,738 Previous Clinical Trials

1,844,311 Total Patients Enrolled

Stephen D. SmithPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

2 Previous Clinical Trials

53 Total Patients Enrolled

Media Library

Loncastuximab Tesirine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05453396 — Phase 2

Non-Hodgkin's Lymphoma Research Study Groups: Treatment (loncastuximab tesirine)

Non-Hodgkin's Lymphoma Clinical Trial 2023: Loncastuximab Tesirine Highlights & Side Effects. Trial Name: NCT05453396 — Phase 2

Loncastuximab Tesirine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05453396 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Loncastuximab Tesirine obtained regulatory clearance from the FDA?

"There is some evidence of Loncastuximab Tesirine's safety, so it earned a score of 2. The lack of efficacy data precludes the medication from receiving higher mark."

Answered by AI

Is this research currently open to participants?

"This investigation is not currently recruiting study participants, as it was last updated on November 2nd 2022. However, there are 3609 other medical trials actively searching for patients to enroll in their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies

2023. "Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05453396.