BAFF CAR-T Cells for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for people with blood cancers like certain lymphomas, leukemias, or multiple myeloma that have not responded to standard treatments. Participants should be adults whose cancer has come back or hasn't improved after previous therapies.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- LMY-922
Trial Overview
The study is testing a new treatment called BAFF CAR-T cells (LMY-922), which are specially modified immune cells designed to target and attack hard-to-treat blood cancers. This early-phase trial aims to find a safe dose and see if the treatment works.
How Is the Trial Designed?
12
Treatment groups
Experimental Treatment
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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Who Is Running the Clinical Trial?
Luminary Therapeutics
Lead Sponsor
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