BridgeMD
New treatment option for Relapsed CLL
Official title Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
ClinicalTrials.gov ID: NCT06916767
What this study is testing
What is BAFF CAR-T?
BAFF CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed cll.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- CAR-T cell treatment of refractory lymphoma has shown success, particularly with CD-19 targeted CAR-T cells, however, many participants are refractory or relapse after response. Responses are more limited in CLL/SLL, possibly secondary to the suppressive effect of circulating B cells on T cell function.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed chronic lymphocytic leukemia (including small lymphocytic lymphoma)
- Relapsed after 2 or more lines of therapy, including a BTK inhibitor and a BCL2 inhibitor.
- No evidence of CNS lymphoma.
- Male or female ≥ 18 years of age.
- ECOG Performance status ≤ 2 [See Appendix 1].
You likely can't join if
- The presence of any of the following will exclude a participant from study enrollment:
- 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. Participants with untreated brain metastases/CNS disease will be...
- Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast).
See the full eligibility criteria
Who can join
- Histologically confirmed chronic lymphocytic leukemia (including small lymphocytic lymphoma)
- Relapsed after 2 or more lines of therapy, including a BTK inhibitor and a BCL2 inhibitor.
- No evidence of CNS lymphoma.
- Male or female ≥ 18 years of age.
- ECOG Performance status ≤ 2 [See Appendix 1].
- Presence of Presence of active disease for participants with CLL and SLL and presence of measurable disease for participants with SLL. A. CLL/SLL (note that SLL participants must have both measurable disease and active...
- 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 × 109/L are generally regarded as...
- Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
- 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 (ie, ECOG performance scale 2 or worse; cannot work or unable to perform usual activities).
- Fevers ≥100.5°F or 38.0°C for 2 or more weeks without evidence of infection.
- Night sweats for ≥1 month without evidence of infection. B. Measurable disease for participants with SLL: At least one measurable lesion according to Lugano Revised Response Criteria for Malignant Lymphoma.
- \>2 weeks since prior radiation therapy or 5 half-lives for systemic therapy at the time of leukapheresis, whichever is shorter (Note: Obinutuzumab pre-treatment of CLL/SLL participants must start at the latest 14 days...
- Total bilirubin ≤ 1.5 X upper institutional limit of normal (except in participants with Gilbert's syndrome, active hemolysis or disease involvement of the liver).
- AST (SGOT)/ALT ≤ 2.5 X institutional upper limit of normal.
- Calculated creatinine clearance ≥ 30ml/min.
- Cardiac ejection fraction of ≥50%
- Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
- Participants (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...
- 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...
What rules you out
- The presence of any of the following will exclude a participant from study enrollment:
- 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. Participants with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and...
- Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast).
- Known active additional malignancies which require systemic treatment (non-immediately morbid malignancies receiving only low-toxicity regimens such as hormone suppression for prostate or breast cancer may be allowed at...
- Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.
- 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...
- Active infection requiring intravenous systemic treatment.
- HIV seropositivity.
- Pregnant or breastfeeding women are excluded from this study because LMY-920 therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative...
- 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. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase...
- Participants with history of active and clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's...
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities...
- History of autoimmune disease (i.e., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medications (other than low dose steroids) within 6 months. Pre-infusion Safety Check
- Participants will undergo a pre-lymphodepletion safety check in the 48h preceding lymphodepletion with Fludarabine and Cyclophosphamide. The objective of these criteria is to avoid infusion in participants with acutely...
- Participants must continue to meet eligibility criteria prior to initiation of lymphodepletive chemotherapy, with exception of the absolute lymphocyte count. This eligibility re-check will be done up to 48 hours prior...
- Symptoms, signs or laboratory markers of active infection or systemic inflammatory response.
- Symptoms, signs or laboratory markers of an uncontrolled medical condition, including but not limited to decompensation of cardiac or pulmonary conditions. These changes exclude symptoms, signs or laboratory markers of...
- Total bilirubin ≤ 2 times the institutional upper limit of normal unless bilirubin rise is due to Gilbert's syndrome (maximum 2 times normal) or of non - hepatic origin.
- AST (SGOT) and ALT (SGPT) ≤ 4 X institutional upper limit of normal
- Serum Creatinine ≤ 2 X the institutional upper limit of normal
- Participants must have adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
- Absence of clinical signs, symptoms, or laboratory markers of cardiac dysfunction. The following findings at the pre - infusion safety check will require a delay in the infusion until resolved:
- Use of corticosteroids within 2 days prior to day 0 infusion, with the exception of agents used for prevention of emesis during lymphodepletive chemotherapy.
- Neurologic symptoms suggestive of an active central nervous system condition.
- Signs or laboratory markers of active infection or systemic inflammatory response. Participants presenting any of the following findings will NOT receive a LMY- 920 infusion:
- Signs or laboratory markers of active infection or systemic inflammatory response.
- Participants with fever over 38.2 degrees Celsius (detected in 2 separate measurements separated by at least 15 minutes)
- Delay and re-conditioning (if delay is longer than 48 hours) can be considered in participants who have resolution of their symptoms.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.