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CAR T-cell Therapy

CLBR001 + SWI019 for Lymphoma

Phase 1

Waitlist Available

Led By Carolyn Mulroney, MD

Research Sponsored by Calibr, a division of Scripps Research

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

Patients must have received adequate prior therapy including at least two lines of prior therapies including anthracycline or bendamustine-containing chemotherapy, anti-CD20 (cluster of differentiation antigen 20) therapies and/or Brutton's tyrosine kinase (BTK) inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing a new immunotherapy treatment for patients with B cell malignancies who have not responded to other treatments. The treatment involves infusions of CLBR001 cells, followed by cycles of SWI019. The goal is to assess the safety and maximum tolerated dose of the treatment.

Who is the study for?

This trial is for adults with certain types of B-cell malignancies that haven't responded to standard treatments. They must have tried at least two previous therapies, be ineligible for stem cell transplant, and have a life expectancy of at least 12 weeks. Participants need functioning major organs and agree to use birth control.Check my eligibility

What is being tested?

The trial tests CLBR001 + SWI019 as an immunotherapy combo for B-cell malignancies. It aims to find the safest dose by giving patients one infusion of CLBR001 followed by cycles of SWI019 while monitoring safety, tolerability, and how the body processes these drugs.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever or fatigue, organ inflammation, or complications from needle biopsies required in the study. The exact side effects will be studied during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have had at least two prior treatments for my condition, including specific drugs like anthracycline or therapies targeting CD20 or BTK.

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I have been treated with CD19-targeted therapy and my disease is confirmed to be CD19 positive.

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My B cell cancer has come back or didn't respond to treatment.

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I am not eligible for a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events

Number of first cycle dose limiting toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE)

Secondary outcome measures

Apparent elimination half-life (t1/2) of SWI019

Area under the curve (AUC) of SWI019

Clearance (CL) of SWI019

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

CLBR001 + SWI019 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Calibr, a division of Scripps ResearchLead Sponsor

5 Previous Clinical Trials

239 Total Patients Enrolled

Carolyn Mulroney, MDPrincipal InvestigatorUniversity of California, San Diego

Media Library

Chronic Lymphocytic Leukemia Clinical Trial 2023: CLBR001 Highlights & Side Effects. Trial Name: NCT04450069 — Phase 1

Frequently Asked Questions

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

Are individuals still being accepted for participation in this research endeavor?

"Based on the details hosted on clinicaltrials.gov, this trial remains open for enrollment; it was created in August of 2020 and has enjoyed recent updates as recently as July 2022."

Answered by AI

How many participants have thus far enrolled in this medical research?

"Affirmative. Clinicaltrials.gov affirms that this medical study is actively seeking participants, having first been posted on August 14th 2020 and was recently updated July 26th 2022. 36 patients are required to be enrolled from 8 distinct sites of care."

Answered by AI

To what extent can CLBR001 and SWI019 prove deleterious to human health?

"CLBR001 and SWI019 have only been exposed to minimal clinical testing, so their safety score is a 1 on the 1-3 scale."

Answered by AI

How many sites are participating in this investigation throughout the state?

"8 different sites are running this trial, including locations like University of California at San Diego in San Diego, City of Hope National Medical Center in Duarte and Weill Cornell Medical College - New york Presbyterian Hospital in New York. In addition to these 3 sites there are 5 other medical facilities offering the same services."

Answered by AI

What goals are researchers attempting to accomplish through this clinical trial?

"This 35-day trial will measure the number of dose limiting toxicities (DLT) through Common Terminology Criteria for Adverse Events (CTCAE). Subsequent outcomes include overall best objective response by Response Evaluation Criteria in Lymphoma and Lugano criteria, duration of response after CLBR001 and SWI019 administration, as well as maximum drug concentration of SWI019 in a patient's peripheral blood."

Answered by AI