Non-Hodgkin LymphomaPhase 1NCT07679919
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies
A Phase 1 study testing LMY-922 in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Luminary Therapeutics at 1 site in United States.
Trial summary
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, 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 to 75 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Hairy Cell Leukemia
- What is being tested?
- LMY-922
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female 18-75 years of age. 2. Patient with:
- NHL: Histologically confirmed B cell NHL (including but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, MCL, marginal zone lymphoma (MZL)) i. Relapsed after 2 or more lines of therapy, or ii. Have disease refractory to prior 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), and iii. Measurable disease per Lugano Revised Response Criteria for Malignant Lymphoma
- or
- CLL: histologically confirmed CLL i. Relapsed after 2 or more lines of therapy ii. Previous therapies prescribed must have included a Bruton's tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor, iii. Measurable disease and active disease: Active disease as defined by the iwCLL criteria, meeting at least one of the following criteria:
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia. Cutoff levels of Hb <10 g/dL or platelet counts <100 × 10^9/L are generally regarded as indication for treatment.
- Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
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- Massive nodes (i.e., ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine, etc.).
- Disease-related symptoms as defined by any of the following:
- Unintentional weight loss ≥10% within the previous 6 months.
- Significant fatigue (i.e., Eastern Cooperative Oncology Group (ECOG) performance scale 2 or worse; cannot work or unable to perform usual activities).
- Fevers ≥ 38.0°C for 2 or more weeks without evidence of infection.
- Night sweats for ≥1 month without evidence of infection.
- or
- HCL: histologically confirmed HCL i. Relapsed after at least one line of therapy, which must have included a purine nucleoside (eg. fludarabine, cladribine or pentostatin) and moxetumomab pasudotox.
- Need for treatment as evidenced by any one of the following: Absolute Neutrophil Count (ANC) <1 × 10^3/mcL, Hb <10g/dL, platelet count <100 × 10^3/mcL, leukemia cell count >5 × 10^3/mcL, symptomatic splenomegaly, or enlarging HCL mass >2 cm in short axis.
- or
- MM: histologically confirmed MM i. Relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
- Measurable disease per IMWG uniform response criteria 3. Adequate organ function as defined by:
- Creatinine clearance more than or equal to 45 ml/min calculated by the Cockcroft - Gault formula
- Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.
- Adequate pulmonary function with pulse oximetry ≥ 92% on room air.
- Total Bilirubin < 1.5× the institutional upper limit of normal (<2.5× if caused by the baseline cancer and in patients with Gilbert's syndrome).
- Alanine aminotransferase (ALT (Serum Glutamic-Pyruvic Transaminase (SGPT))) and Aspartate Aminotransferase (AST (Serum Glutamic-Oxaloacetic Transaminase (SGOT) < 2.5× the institutional upper limit of normal.
- 4. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
- 5. 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 1 year after CAR-T cell infusion.
- A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- The reliability of sexual abstinence should be evaluated in relation to the duration
- of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- 6. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 1 year after CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 1 year after CAR-T cell infusion to avoid potential embryonal or fetal exposure.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- 7. Body weight of at least 55kg for patients treated at dose level 3 (450 × million BAFF+ CAR cells) and at least 37kg for all other dose levels.
Who cannot join
- Second active (i.e., currently requires antineoplastic therapy) non-B cell lineage malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).
- Renal failure requiring regular dialysis.
- Uncontrolled pulmonary disease or infection.
- Cardiovascular disorders including symptomatic congestive heart failure, 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 systemic treatment.
- HIV seropositive with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months of enrollment, or has not been on an established antiretroviral therapy (ART) for at least four weeks with an HIV viral load less than 400 copies/mL.
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- Pregnant or breastfeeding women are excluded from this study (breastfeeding should be discontinued), because there is an unknown, but potential risk for adverse events in fetuses and nursing infants secondary to treatment of the mother with LMY-922 and lymphodepleting chemotherapy. Women of childbearing potential must have a negative serum pregnancy test.
- Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
- Patients with history of clinically relevant central nervous system (CNS) pathology such as uncontrolled epilepsy, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia, and Parkinson's disease.
- Subjects with uncontrolled intercurrent or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients receiving a live vaccine within 2 weeks prior to screening.
- Concurrent use of high dose systemic steroids and/or immunosuppressive therapies.
- Steroid dose must be weaned to ≤10 mg/day prednisone equivalent prior to CAR-T cell infusion.
- Immunosuppressive medications must be stopped at least 5 half-lives prior to CAR-T cell infusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Taussig Cancer Institute | Cleveland Clinic
Cleveland, Ohio, 44195
Paolo F Caimi, MD, 216 445-4635, CAIMIP@ccf.org
Cancer Answer line, 866-223-8100
About this study
Official title: A Phase 1 Study of Allogeneic (γ/δ) BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, 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 hematologic malignancies, 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 refractory hematologic malignancies using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.
Read the detailed description
LMY-922 is an allogeneic CAR-T cell therapy consisting of allogeneic 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 refractory hematologic malignancies. The goal of LMY-922-002 phase 1 study is to find the recommended phase 2 dose of LMY-922 for treatment of patients with refractory hematologic malignancies.
- Being tested
- LMY-922
- Keywords
- Lymphoma, B-cell
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Hairy Cell, Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMY-922Biological
Also called BAFF CAR-T Cells
Allogeneic CAR-T cell therapy expressing the BAFF-ligand
| Study group | Role | What they receive |
|---|---|---|
| Non-Hodgkin Lymphoma: LMY-922 Dose Level -1 | Experimental | Dose Level -1 of 75 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Non-Hodgkin Lymphoma: LMY-922 Dose Level 1 | Experimental | Dose Level 1 of 150 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Non-Hodgkin Lymphoma: LMY-922 Dose Level 2 | Experimental | Dose Level 2 of 300 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Non-Hodgkin Lymphoma: LMY-922 Dose Level 3 | Experimental | Dose Level 3 of 450 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level -1 | Experimental | Dose Level -1 of 75 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 1 | Experimental | Dose Level 1 of 150 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 2 | Experimental | Dose Level 2 of 300 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 3 | Experimental | Dose Level 3 of 450 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Multiple Myeloma: LMY-922 Dose Level -1 | Experimental | Dose Level -1 of 75 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Multiple Myeloma: LMY-922 Dose Level 1 | Experimental | Dose Level 1 of 150 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Multiple Myeloma: LMY-922 Dose Level 2 | Experimental | Dose Level 2 of 300 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
| Multiple Myeloma: LMY-922 Dose Level 3 | Experimental | Dose Level 3 of 450 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. Receives: Biological: LMY-922 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety profile of LMY-922 in patients with refractory hematologic malignancies.
Incidence and severity of treatment-emergent adverse events
Measured: 12 Months
To determine the Recommended Phase II Dose of LMY-922 in patients with refractory hematologic malignancies.
Incidence of dose limiting toxicities (DLT)
Measured: 12 Months
Secondary outcomes (4)
Response rates for each malignancy
NHL: per Lugano Revised Response Criteria for Malignant Lymphoma; CLL: per 2018 iwCLL criteria; HCL: per Consensus Guidelines for The Diagnosis and Management of Patients with Classic Hairy Cell Leukemia; MM: per IMWG uniform response criteria
Measured: 12 Months
Progression free survival (PFS) for each malignancy
Progression free survival
Measured: 12 Months
Duration of response for each malignancy
Duration of response
Measured: 12 Months
Overall survival (OS) for each malignancy
Overall survival
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luminary Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679919
- Sponsor's protocol ID
- LMY-922-002
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Allogeneic (γ/δ) BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT07679919
- Acronym / sponsor ID
- LMY-922-002
- Keywords
- Lymphoma, B-cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Luminary TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, 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 hematologic malignancies, 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 refractory hematologic malignancies using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.
Detailed description
LMY-922 is an allogeneic CAR-T cell therapy consisting of allogeneic 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 refractory hematologic malignancies. The goal of LMY-922-002 phase 1 study is to find the recommended phase 2 dose of LMY-922 for treatment of patients with refractory hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Non-Hodgkin Lymphoma: LMY-922 Dose Level -1 | Experimental | Biological: LMY-922Dose Level -1 of 75 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Non-Hodgkin Lymphoma: LMY-922 Dose Level 1 | Experimental | Biological: LMY-922Dose Level 1 of 150 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Non-Hodgkin Lymphoma: LMY-922 Dose Level 2 | Experimental | Biological: LMY-922Dose Level 2 of 300 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Non-Hodgkin Lymphoma: LMY-922 Dose Level 3 | Experimental | Biological: LMY-922Dose Level 3 of 450 million BAFF+ CAR cells for the non-Hodgkin lymphoma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level -1 | Experimental | Biological: LMY-922Dose Level -1 of 75 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 1 | Experimental | Biological: LMY-922Dose Level 1 of 150 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 2 | Experimental | Biological: LMY-922Dose Level 2 of 300 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 3 | Experimental | Biological: LMY-922Dose Level 3 of 450 million BAFF+ CAR cells for the Chronic Lymphocytic Leukemia / Hairy Cell Leukemia group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Multiple Myeloma: LMY-922 Dose Level -1 | Experimental | Biological: LMY-922Dose Level -1 of 75 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Multiple Myeloma: LMY-922 Dose Level 1 | Experimental | Biological: LMY-922Dose Level 1 of 150 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Multiple Myeloma: LMY-922 Dose Level 2 | Experimental | Biological: LMY-922Dose Level 2 of 300 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
| Multiple Myeloma: LMY-922 Dose Level 3 | Experimental | Biological: LMY-922Dose Level 3 of 450 million BAFF+ CAR cells for the Multiple Myeloma group of an open label, dose escalation study with up to four dose levels of LMY-922. The maximum tolerated dose of LMY-922 will be determined using dose-escalation 3+3 design. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- NHL: Histologically confirmed B cell NHL (including but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, MCL, marginal zone lymphoma (MZL)) i. Relapsed after 2 or more lines of therapy, or ii. Have disease refractory to prior 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), and iii. Measurable disease per Lugano Revised Response Criteria for Malignant Lymphoma
- or
- CLL: histologically confirmed CLL i. Relapsed after 2 or more lines of therapy ii. Previous therapies prescribed must have included a Bruton's tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor, iii. Measurable disease and active disease: Active disease as defined by the iwCLL criteria, meeting at least one of the following criteria:
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia. Cutoff levels of Hb <10 g/dL or platelet counts <100 × 10^9/L are generally regarded as indication for treatment.
- Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
Key exclusion criteria (14 listed)
- Second active (i.e., currently requires antineoplastic therapy) non-B cell lineage malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).
- Renal failure requiring regular dialysis.
- Uncontrolled pulmonary disease or infection.
- Cardiovascular disorders including symptomatic congestive heart failure, 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 systemic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMY-922Also: BAFF CAR-T CellsAllogeneic CAR-T cell therapy expressing the BAFF-ligand | Biological | Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level -1, Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 1, Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 2, Chronic Lymphocytic Leukemia / Hairy Cell Leukemia: LMY-922 Dose Level 3, Multiple Myeloma: LMY-922 Dose Level -1, Multiple Myeloma: LMY-922 Dose Level 1, Multiple Myeloma: LMY-922 Dose Level 2, Multiple Myeloma: LMY-922 Dose Level 3, Non-Hodgkin Lymphoma: LMY-922 Dose Level -1, Non-Hodgkin Lymphoma: LMY-922 Dose Level 1, Non-Hodgkin Lymphoma: LMY-922 Dose Level 2, Non-Hodgkin Lymphoma: LMY-922 Dose Level 3 |
Primary outcome
To assess the safety profile of LMY-922 in patients with refractory hematologic malignancies.
Time frame: 12 Months
Incidence and severity of treatment-emergent adverse events
To determine the Recommended Phase II Dose of LMY-922 in patients with refractory hematologic malignancies.
Time frame: 12 Months
Incidence of dose limiting toxicities (DLT)
4 secondary outcomes
Response rates for each malignancy
Time frame: 12 Months
Progression free survival (PFS) for each malignancy
Time frame: 12 Months
Duration of response for each malignancy
Time frame: 12 Months
Overall survival (OS) for each malignancy
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LMY-922 in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Luminary Therapeutics at 1 site 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 33 inclusion and 14 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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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 assess the safety profile of LMY-922 in patients with refractory hematologic malignancies. (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.