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Phase classification, Enrollment change, Trial termination: Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML (clinicaltrials.gov) - Jan 28, 2025
P1, N=16, Terminated,
Phase classification: P1/2 --> P1 | N=102 --> 16 | Active, not recruiting --> Terminated; The decision to discontinue LAVA-051clinical trial follows a recent review of the competitive landscape that has continued to evolve (Business decision). The decision is not due to safety concerns.
- |||||||||| MODULE 5: Chimeric Antigen Receptor (CAR) T-Cell Therapy and Other Novel Strategies for CLL (Manchester Grand Hyatt San Diego, Seaport Ballroom EFGH; In-Person; Virtual) - Oct 5, 2024 - Abstract #ASH2024ASH_79;
The decision is not due to safety concerns. This program is supported by educational grants from AstraZeneca Pharmaceuticals LP, BeiGene Ltd and Eli Lilly.Biological rationale for the investigation of CD19- directed CAR T-cell therapy for CLL Published efficacy and safety findings with lisocabtagene maraleucel (liso-cel) for R/R CLL from the Phase I/II TRANSCEND CLL 004 trial FDA approval of liso-cel for CLL previously treated with a BTK inhibitor and a Bcl-2 inhibitor; current clinical role and optimal patient selection Early findings with other CAR T-cell-based approaches (eg, liso-cel in combination with ibrutinib, brexucabtagene autoleucel, rapcabtagene autoleucel) for heavily pretreated CLL Antitumor activity observed with bispecific antibody therapy (eg, epcoritamab, NVG-111, LAVA-051) for CLL, including in patients with Richter's transformation Other promising agents and strategies under investigation for CLL
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Enrollment closed: Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML (clinicaltrials.gov) - Jun 22, 2023
P1/2, N=102, Active, not recruiting,
This program is supported by educational grants from AstraZeneca Pharmaceuticals LP, BeiGene Ltd and Eli Lilly.Biological rationale for the investigation of CD19- directed CAR T-cell therapy for CLL Published efficacy and safety findings with lisocabtagene maraleucel (liso-cel) for R/R CLL from the Phase I/II TRANSCEND CLL 004 trial FDA approval of liso-cel for CLL previously treated with a BTK inhibitor and a Bcl-2 inhibitor; current clinical role and optimal patient selection Early findings with other CAR T-cell-based approaches (eg, liso-cel in combination with ibrutinib, brexucabtagene autoleucel, rapcabtagene autoleucel) for heavily pretreated CLL Antitumor activity observed with bispecific antibody therapy (eg, epcoritamab, NVG-111, LAVA-051) for CLL, including in patients with Richter's transformation Other promising agents and strategies under investigation for CLL Recruiting --> Active, not recruiting
- |||||||||| LAVA-051 / LAVA Therap
Journal: A bispecific T (Pubmed Central) - Mar 4, 2023
bsTCE in NHPs shows V?9V?2-T cell engagement and excellent tolerability. Based on these results, CD1d-V?2 bsTCE (LAVA-051) is now evaluated in a phase 1/2a study in patients with therapy refractory CLL, MM, or AML.
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Trial completion date, Trial primary completion date: Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML (clinicaltrials.gov) - Jan 11, 2023
P1/2, N=102, Recruiting,
Based on these results, CD1d-V?2 bsTCE (LAVA-051) is now evaluated in a phase 1/2a study in patients with therapy refractory CLL, MM, or AML. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
- |||||||||| LAVA-051 / LAVA Therap
Bispecific Vγ9Vδ2-T and Type 1 NKT Cell Engager Lava-051 As First-in-Class Clinical Candidate to Target CD1d Expressing CLL, MM and AML (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3885;
P1/2
In this study, we demonstrate that the CD1d-Vδ2 bsVHH LAVA-051 triggers activation of both type 1 NKT and Vγ9Vδ2-T cells, which translates directly into antitumor activity. Based on the expression of CD1d in CLL, MM, and AML, the strong preclinical activity of LAVA-051 against CD1d-expresssing tumors, and the favorable tolerability profile of the surrogate engager in NHP, LAVA-051 is currently evaluated in a first-in-human clinical Phase 1/2a study in patients with CD1d-expressing CLL, MM, or AML refractory to prior therapy (NCT04887259).
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Enrollment open: Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML (clinicaltrials.gov) - May 24, 2021
P1/2, N=55, Recruiting,
Based on the expression of CD1d in CLL, MM, and AML, the strong preclinical activity of LAVA-051 against CD1d-expresssing tumors, and the favorable tolerability profile of the surrogate engager in NHP, LAVA-051 is currently evaluated in a first-in-human clinical Phase 1/2a study in patients with CD1d-expressing CLL, MM, or AML refractory to prior therapy (NCT04887259). Not yet recruiting --> Recruiting
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