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Lymphoma, Non-Hodgkin Lymphoma, B-CellPhase 1NCT05312801

Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma

A Phase 1 study testing BAFF CAR-T in people with Lymphoma, Non-Hodgkin Lymphoma, B-Cell, run by Luminary Therapeutics at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin Lymphoma, B-Cell
What is being tested?
BAFF CAR-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
21 Nov 2023to 2 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or disease refractory to chemotherapy (defined as progressive disease or stable disease lasting ≤6 months, as best response to most recent chemotherapy regimen; or disease progression or recurrence ≤12 months after prior autologous stem cell transplantation (ASCT).
  • No evidence of central nervous system (CNS) lymphoma.
  • Male or female > 18 years of age.
  • Eastern Cooperative Oncology Group Performance status ≤ 2.
  • At least one measurable lesion.
  • >2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis.
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  • Total bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's syndrome).
  • Aspartate aminotransferase/alanine transferase ≤ 2.5 X institutional upper limit of normal.
  • Serum creatinine < 1.5 mg/dL.
  • Cardiac ejection fraction of >50%, and no evidence of pericardial effusion, as determined by an echocardiogram.
  • Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
  • Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.

Who cannot join

  • ASCT within 6 weeks of informed consent.
  • History of allogeneic hematopoietic stem cell transplantation.
  • Active graft-versus-host disease.
  • Active central nervous system or meningeal involvement by lymphoma or leukemia.
  • Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).
  • Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.
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  • New York Heart Association class IV congestive heart failure.
  • Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.
  • Active infection requiring intravenous systemic treatment.
  • HIV seropositivity.
  • Pregnant or breastfeeding women.
  • Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
  • Serologic status reflecting active hepatitis B or C infection.
  • Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.
  • Subjects with uncontrolled intercurrent illness.
  • Known additional malignancies which require systemic treatment.
  • History of autoimmune disease with requirement of immunosuppressive medications (other than low dose steroids) within 6 months.

Trial locations and contacts

2 sites in 1 country.

Paolo F. Caimi, MD contact

216 445-4635

CAIMIP@ccf.org

United States2 sites, 2 recruiting

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

    Leland Metheny, MD, 2168440139, Leland.Metheny@uhhospitals.org

    Not yet recruiting

  • Taussig Cancer Institute | Cleveland Clinic

    Cleveland, Ohio, 44195

    Paolo F Caimi, MD, caimip@ccf.org

    Kimberly Grundey, MSN RN, 2164424583, mailto:GRUNDEK@ccf.org

    Recruiting

Other trials in United States

About this study

Official title: LMY-920 for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment.

This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.

Read the detailed description

LMY-920 is an autologous CAR-T cell therapy consisting of autologous cluster of differentiation 4 (CD4) positive and cluster of differentiation 8 (CD8) positive human T cells that are genetically engineered using the non-viral transposon system to express the BAFF-ligand CAR-T that target BAFF receptor family members to eliminate malignant B cells.

BAFF receptor family includes B-cell activating factor receptor (BR3), B-cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI). These receptors are present on non-Hodgkin lymphoma.

The goal of LMY-920-001 phase 1 study is to find recommended phase 2 dose of LMY-920 for treatment of patients with relapsed or refractory non-Hodgkin lymphoma.

Being tested
BAFF CAR-T
Keywords
non-Hodgkin lymphoma.
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAFF CAR-TDrug

    Also called LMY-920

    Autologous CAR-T cell therapy expressing the BAFF-ligand.

Study groups in NCT05312801
Study groupRoleWhat they receive
LMY-920 dose escalationExperimentalOpen label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.
Receives: Drug: BAFF CAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine recommended phase II dose of human LMY-920.

    Maximum tolerated dose.

    Measured: 24 months

Secondary outcomes (8)

  1. To establish toxicity profile for the infusion of LMY-920.

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. All adverse events during study will be collected, categorized, and graded. Attribution of relatedness to the investigational agent will be assigned.

    Measured: 24 months

  2. To determine the objective response rate .

    Response rate.

    Measured: 24 months

  3. To determine the complete response rate.

    Response rate.

    Measured: 24 months

  4. To determine the duration of response.

    Duration of response.

    Measured: 24 months

  5. To determine the progression-free survival.

    Progression-free survival.

    Measured: 24 months

  6. To determine the overall survival.

    Overall survival.

    Measured: 24 months

  7. To determine incidence of adverse events.

    Incidence of adverse events.

    Measured: 24 months

  8. To determine incidence of anti- LMY-920 antibodies.

    Incidence of anti- LMY-920 antibodies.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2022
  2. Study start21 Nov 2023
  3. Primary completion1 May 2025 (estimated)
  4. Study completion2 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Open label, dose escalation study. Dose Levels 1. 1 x 10 million BAFF+ CAR cells/kg 2. 2 x 10 million BAFF+ CAR cells/kg 3. 4 x 10 million BAFF+ CAR cells/kg 4. 8 x 10 million BAFF+ CAR cells/kg
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312801
Sponsor's protocol ID
LMY-920-001
Status last verified
Oct 2024
First submitted
24 Mar 2022
Last updated
21 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAFF CAR-T in people with Lymphoma, Non-Hodgkin Lymphoma, B-Cell, run by Luminary Therapeutics at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paolo F. Caimi, MD (216 445-4635, CAIMIP@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine recommended phase II dose of human LMY-920. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05312801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.

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