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DRUG:

Allocetra (HLA-matched donor mononuclear enriched leukocytes)

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Other names: leukocyte stem cell therapy, autologous apoptotic cell-based therapy, non-HLA-matched allogeneic peripheral blood mononuclear cells
Associations
Trials
Company:
Enlivex Therap
Drug class:
Immunomodulator
Related drugs:
Associations
Trials
4ms
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients (clinicaltrials.gov)
P2, N=148, Completed, Enlivex Therapeutics Ltd. | Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Dec 2024
Trial completion • Trial completion date
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Allocetra (HLA-matched donor mononuclear enriched leukocytes)
4ms
ENX-CL-06-001: Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis (clinicaltrials.gov)
P1, N=6, Recruiting, Enlivex Therapeutics Ltd. | Trial completion date: Jan 2026 --> Sep 2026
Trial completion date
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Allocetra (HLA-matched donor mononuclear enriched leukocytes)
4ms
ENX-CL-05-001: Study of Intra-articular Allocetra in Knee Osteoarthritis (clinicaltrials.gov)
P1/2, N=160, Active, not recruiting, Enlivex Therapeutics Ltd. | Trial primary completion date: Jun 2025 --> Sep 2025
Trial primary completion date
|
Allocetra (HLA-matched donor mononuclear enriched leukocytes)
7ms
ENX-CL-05-001: Study of Intra-articular Allocetra in Knee Osteoarthritis (clinicaltrials.gov)
P1/2, N=160, Active, not recruiting, Enlivex Therapeutics Ltd. | Recruiting --> Active, not recruiting
Enrollment closed
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Allocetra (HLA-matched donor mononuclear enriched leukocytes)
1year
Enrollment open
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Allocetra (HLA-matched donor mononuclear enriched leukocytes)
over1year
Apoptotic Cell-Based Therapy for the Modification of the Inflammatory Response to Hemorrhagic Shock. (PubMed, Mil Med)
In a pressure-control hemorrhagic shock model in rats, apoptotic cell infusion showed preliminary signs of a uniform attenuated cytokine response. Apoptotic cell-based therapies might serve as a novel immunomodulatory therapy for hemorrhagic shock.
Journal
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL1B (Interleukin 1, beta)
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Allocetra (HLA-matched donor mononuclear enriched leukocytes)
over1year
New P1 trial
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Allocetra (HLA-matched donor mononuclear enriched leukocytes)
over1year
New P1/2 trial
|
Allocetra (HLA-matched donor mononuclear enriched leukocytes)
over1year
Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis (clinicaltrials.gov)
P1/2, N=9, Terminated, Enlivex Therapeutics RDO Ltd. | Trial completion date: Sep 2024 --> Mar 2024 | Recruiting --> Terminated | Trial primary completion date: Oct 2023 --> Mar 2024; Sponsor decision
Trial completion date • Trial termination • Trial primary completion date
|
Allocetra (HLA-matched donor mononuclear enriched leukocytes)
over1year
A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy (clinicaltrials.gov)
P1/2, N=14, Terminated, Enlivex Therapeutics RDO Ltd. | N=72 --> 14 | Trial completion date: Dec 2024 --> Apr 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Apr 2024; Sponsor decision
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
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Opdivo (nivolumab) • Tevimbra (tislelizumab-jsgr) • Allocetra (HLA-matched donor mononuclear enriched leukocytes)
over1year
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients (clinicaltrials.gov)
P2, N=160, Active, not recruiting, Enlivex Therapeutics Ltd. | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2024 --> Dec 2024
Enrollment closed • Trial primary completion date
|
Allocetra (HLA-matched donor mononuclear enriched leukocytes)
over1year
A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients With Severe or Critical COVID-19 With Associated Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov)
P2, N=12, Terminated, Enlivex Therapeutics Ltd. | Phase classification: P2b --> P2 | Trial completion date: Sep 2023 --> Mar 2024 | Active, not recruiting --> Terminated; strategic reprioritization
Phase classification • Trial completion date • Trial termination
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Allocetra (HLA-matched donor mononuclear enriched leukocytes)