CompletedPhase 1

CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies

United States18 participantsStarted 2020-08-14

Plain-language summary

CLBR001 + SWI019 is an combination investigational immunotherapy being evaluated as a potential treatment for patients diagnosed with B cell malignancies who are refractory or unresponsive to salvage therapy or who cannot be considered for or have progressed after autologous hematopoietic cell transplantation. This first-in-human study will assess the safety and tolerability of CLBR001 + SWI019 and is designed to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD). Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019. The study will also assess the pharmacokinetics and pharmacodynamics of CLBR001 + SWI019.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with relapsed / refractory previously treated B cell malignancies (according to the World Health Organization classification; 2017) * 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 * Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have confirmed CD19+ disease * Patients must be ineligible for allogeneic stem cell transplant (SCT) * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Estimated life expectancy of ≥ 12 weeks from the first day of SWI019 dose administered * Willing to undergo pre- and post-treatment core needle biopsy * Adequate hematological, renal, pulmonary, cardiac, and liver function * Resolved adverse events of any prior therapy to either baseline or CTCAE Grade ≤1 * Women of childbearing potential, a negative pregnancy test and must agree to practice effective birth control * Men sexually active with female partners of child bearing potential must agree to practice effective contraception * Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures Exclusion Criteria: * Patients diagnosed with certain disease histologies including pediatric lymphomas/leukemias, monoclonal gammopathy of undetermined significa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 35 days

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

Timeframe: up to 1 year

Trial details

NCT IDNCT04450069

SponsorCalibr, a division of Scripps Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-06

View on ClinicalTrials.gov More Relapsed/Refractory B-cell Lymphomas trials