By InvitationPhase 1

CD19.20.22 CAR T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas

United States15 participantsStarted 2024-10-28

Plain-language summary

The goal of this study is to treat patients diagnosed with relapsed or refractory positive B cell lymphoma - positive for 2 or more target antigens - with CAR19.20.22 CAR T-cells. Based on the preclinical characteristics of the LTG2950, CAR19.20.22 tri-specific CAR T-cells the Investigators have developed the following hypotheses to be tested in our phase Ia clinical trial. The Investigators hypothesize that these novel CAR T-cells will show: * good safety and tolerability * a high degree of efficacy * very good persistence * an acceptable level of exhaustion

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: * Age ≥ 18 years * Histologically confirmed relapsed/refractory B cell Lymphoma. Histologies allowed: diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL), Follicular Lymphoma (FL), transformed follicular lymphoma (tFL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Richter's transformation with or without concurrent CLL, Burkitt's lymphoma. * Relapsed or Refractory disease after two lines or more of therapy (except one or more line for MCL) including rituximab and other anti-CD20 antibodies, BTK inhibitors (Mantle Cell Lymphoma only), and anthracycline (specifically for DLBCL, PMBCL, tFL, and Burkitt's lymphoma). * Measurable disease according to Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma \[2\]. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. If the only measurable disease is lymph node disease, at least 1 lymph node should be ≥ 1.5 cm. * Two out of three target antigen expression required (IHC or flow per institutional guidelines) on the most recent biopsy available. We will analyze a tumor sample from the most recent relapse or development of refractory disease state (archival sample within \<6 months) for antigen expression. Alternatively, a new biopsy will be obtained in case archival material is not available. *…

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

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Safety and Tolerability]

Timeframe: From date of enrollment assessed up to 24 months

Efficacy Overall Response Rate in participants

Timeframe: From date of enrollment assessed up to 24 months

Change in CAR19.20.22 T-cell function assessed by multicolor ELISPOT assay using CD19/CD22 protein targets.

Timeframe: From date of enrollment assessed up to 24 months

Persistence of CAR19.20.22 T-cells in peripheral blood measured by qPCR vector copy number and flow cytometry enumeration of CD19 and CD22 CAR-expressing T-cells."

Timeframe: From date of enrollment assessed up to 24 months

Trial details

NCT IDNCT07168486

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

View on ClinicalTrials.gov More B-Cell Lymphoma trials

Plain-language summary

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.

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Safety and Tolerability]

Timeframe: From date of enrollment assessed up to 24 months

Efficacy Overall Response Rate in participants

Timeframe: From date of enrollment assessed up to 24 months

Change in CAR19.20.22 T-cell function assessed by multicolor ELISPOT assay using CD19/CD22 protein targets.

Timeframe: From date of enrollment assessed up to 24 months

Persistence of CAR19.20.22 T-cells in peripheral blood measured by qPCR vector copy number and flow cytometry enumeration of CD19 and CD22 CAR-expressing T-cells."

Timeframe: From date of enrollment assessed up to 24 months