plerixafor / Generic mfg. - LARVOL DELTA

Phase 2 Study of Teclistamab-Based Induction Regimens in Patients with Transplant-Eligible (TE) Newly Diagnosed Multiple Myeloma (NDMM): Results from the GMMG-HD10/DSMM-XX (MajesTEC-5) Trial (ASH 2024) - "Daratumumab, a CD38-targeting monoclonal antibody, has shown deep and durable responses and prolonged survival outcomes in combination with lenalidomide and dexamethasone (DRd) and in combination with bortezomib plus lenalidomide and dexamethasone (DVRd), in patients with NDMM...In Cycles 2+, Tec 1.5 mg/kg was given QW in Arm A and 3.0 mg/kg Q4W in Arms A1 and B. SC daratumumab (1800 mg) was administered QW in Cycles 1-2 and Q2W in Cycles 3-6...Among the 23 patients who completed stem cell mobilization, median stem cell yield was 8.7 × 106/kg; 10 (43.5%) patients received plerixafor...Of the patients with MRD assessment at data cut-off, all achieved MRD-negativity (10–5) by the first MRD assessment. Additionally, stem cell mobilization was feasible with Tec-DRd and Tec-DVRd."

Clinical • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukopenia • Multiple Myeloma • Neutropenia • Oncology • Pancreatitis • Transplantation

Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM (clinicaltrials.gov) - P1/2 | N=10 | Enrolling by invitation | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Dermatology • Gene Therapies • Neutropenia

Impact of CXCR4hi neutrophils on airway inflammation in chronic obstructive pulmonary disease (ERS 2026) - "AMD3100 treatment reduced lung inflammation and structural damage. ConclusionCXCR4hi neutrophils specifically accumulate in COPD lungs, driving inflammation and tissue damage through enhanced NETs release, ROS generation, and phagocytosis, highlighting their therapeutic potential."

Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • CXCL12 • CXCR4 • PTPRC

Correlation Between Mobilization Regimen and CD34+ Stem Cell Yield in Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation: A Single-Center Retrospective Analysis (SOHO 2026) - "Interventions: Mobilization regimens included cyclophosphamide plus G-CSF (n = 17); cyclophosphamide plus G-CSF with plerixafor rescue for poor mobilization (n = 8); upfront cyclophosphamide/G-CSF/plerixafor (n = 2); cytarabine plus G-CSF (n = 2); etoposide plus G-CSF with or without plerixafor (n = 2); rescue G-CSF plus plerixafor alone (n = 1); and other complex salvage strategies (n = 1). Cyclophosphamide plus G-CSF with ondemand plerixafor rescue achieved a 100% minimum-yield success rate. Greater lenalidomide exposure was associated with reduced CD34+ yield, supporting earlier mobilization in heavily pretreated patients. Prospective validation in larger cohorts is warranted."

Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology • CD34

Real-World Outcomes of Anti-Cd38-Based Quadruplet Induction Regimens in Newly Diagnosed Multiple Myeloma: A Multinational Latin American Experience. (IMS 2026) - "Frontline regimens included Daratumumab combined with bortezomib, lenalidomide and dexamethasone (D-VRd) in 59%; Daratumumab, bortezomib, thalidomide, dexamethasone (D-VTd) in 36% and Isatuximab CUADS in 5%...However, 1% of collections failed despite plerixafor use in 55% of patients... In this large real-word Latin America experience, anti-CD38-quadruplet induction demonstrated high response depth, frequent MRD negativity, successful stem cell mobilization, and favorable survival outcomes with manageable toxicity. These findings support the feasibility and effectiveness of quadruplet-based strategies for transplant-eligible NDMM patients in Latin America."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Renal Disease • CD34

The Impact of Pomalidomide-Containing Induction on Stem Cell Mobilization and Engraftment in Newly Diagnosed Multiple Myeloma: A Single Center Experience (IMS 2026) - "While lenalidomide-based regimens have been associated with impaired hematopoietic stem cell (HSC) mobilization, clinical data regarding the potential impact of pomalidomide (POM)-containing induction on mobilization outcomes remains extremely limited... This retrospective cohort study analyzed consecutive NDMM patients who underwent HSC mobilization with high-dose cyclophosphamide (HD-CTX) plus pegylated granulocyte colony-stimulating factor (PEG G-CSF) at a single center between January 2023 and December 2025...However, patients in the POM group received a significantly higher number of plerixafor (PXF) doses (p=0.030)... POM-containing induction significantly reduces total CD34+ collection yields and increases PXF requirements. However, it does not preclude the successful harvest of the minimum HSC doses required for transplantation, nor does it compromise post-transplant engraftment. For patients receiving POM-based induction, a risk-adapted mobilization strategy..."

Clinical • Hematological Malignancies • Multiple Myeloma

An open-label, multi-center Phase 2 study to assess the safety and efficacy of burixafor (GPC-100) and propranolol with G-CSF for the mobilization of hematopoietic progenitor cells in patients with multiple myeloma (ASH 2025) - P2 | "Mediantimes to neutrophil and platelet engraftment were 11 days (range 11-17 days) and 15 days (range 11-27days), respectively.ConclusionsBurixafor, in combination with propranolol and G-CSF, demonstrated an excellent safety profile andeffectively mobilized sufficient HPCs for AHCT, including patients previously treated with lenalidomideand daratumumab. Notably, burixafor enabled same-day administration with leukapheresis, offering akey advantage over other CXCR4 inhibitors, such as plerixafor and motixafortide through its rapidmobilization kinetics. Its favorable safety profile, characterized by minimal adverse events, supporting itspotential clinical utility."

Clinical • IO biomarker • P2 data • Cardiovascular • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypotension • Multiple Myeloma • Musculoskeletal Diseases • Musculoskeletal Pain • CD34 • CXCR4

Real-world outcomes of CD34⁺ mobilization and early autologous hematopoietic stem cell transplantation recovery after daratumumab-based induction. (PubMed, Hematol Transfus Cell Ther) - "In this real-world cohort, no significant differences in CD34⁺ mobilization, apheresis outcomes, engraftment, or early post-autologous hematopoietic stem cell transplantation complications were observed based on prior daratumumab exposure. These findings support the safety and feasibility of autologous hematopoietic stem cell transplantation following anti-CD38-based induction regimens, including those incorporating lenalidomide."

Journal • Real-world evidence • Bone Marrow Transplantation • Critical care • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Transplantation • CD34

CXCR4-directed liposomal co-delivery of cytarabine and AMD3100 for redox-associated chemosensitization in acute myeloid leukemia. (PubMed, Colloids Surf B Biointerfaces) - "Here, we developed CTCE-9908-functionalized, cytarabine (Ara-C) and the CXCR4 antagonist AMD3100-coloaded liposomes (C-AM@Lipo) for integrating CXCR4-directed uptake enhancement with redox-associated chemosensitization. DiR-based biodistribution analysis showed enhanced femoral accumulation, while extended safety evaluation demonstrated preserved bone marrow cellularity and no evident hematological or hepatorenal toxicity. Collectively, this study establishes a coordinated liposomal strategy linking CXCR4-associated uptake enhancement with Ara-C/AMD3100 co-delivery and redox-associated chemosensitization for improved AML therapy."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • CXCR4

First-Line Anti-Cd38-Based Quadruplet Induction in Transplant-Eligible Newly Diagnosed Multiple Myeloma: Real-World Results from the Argentine Multiple Myeloma Group (GAMM) (IMS 2026) - "Daratumumab was used in 183 patients (95%) and isatuximab in 10 (5%)...Median CD34+ collection was 5.1 × 10⁶/kg (IQR, 3.5–6.8), plerixafor was required in 112 patients (58%), and collection failure occurred in 2... First-line anti-CD38-based induction followed by ASCT achieved high rates of deep response and encouraging survival in this real-world Argentine cohort, with post-ASCT MRD negativity identifying patients with superior outcomes"

Clinical • Real-world • Real-world evidence • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Metabolic Disorders • Multiple Myeloma • Plasmacytoma • Renal Disease • Transplantation • CD34

Chemo-Free Mobilization with Upfront Plerixafor Improves Efficiency and Reduces Procedural Burden in Multiple Myeloma (IMS 2026) - "In the era of novel induction therapies, particularly lenalidomide and anti-CD38 monoclonal antibodies, impaired mobilization has become increasingly recognized, highlighting the need for optimized strategies in routine clinical practice...Patients received either upfront plerixafor plus G-CSF (PLE group, n=98) or cyclophosphamide plus G-CSF (CY group, n=122)... In this large real-world cohort, upfront plerixafor provided superior mobilization efficiency with reduced toxicity and procedural burden compared with chemotherapy-based strategies, without compromising transplant outcomes. These findings support a shift toward chemo-free mobilization approaches and suggest potential benefits in healthcare resource utilization, particularly in the context of modern induction therapies. This pragmatic strategy may have broad applicability across diverse clinical settings."

Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • CD34

Stem Cell Mobilization Characteristics for Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma (NDMM) Treated with Carfilzomib, Lenalidomide, Dexamethasone, and Daratumumab (KRd-Dara) (ASH 2022) - P2 | "Induction treatment consisted of 28-day cycles of KRd-Dara with intravenous carfilzomib, 20/56 mg/m2 (days 1, 8, and 15); lenalidomide orally, 25 mg (days 1-21); dexamethasone weekly; daratumumab (subcutaneous) per standard approved dosing schedule. The stem cell mobilization failure rate was high in patients collecting after 7 or 8 cycles KRd-Dara. Second remobilization with G-CSF and plerixafor was successful in only 1 of the 4 patients. We have modified stage 2 of the protocol to allow stem cell collection after cycle 3 of KRd-Dara induction."

Clinical • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • CD34

Phase II study of novel CXCR2 agonist and Plerixafor for rapid stem cell mobilization in patients with multiple myeloma. (PubMed, Blood Cancer J) - P2 | "MGTA-145 or GROβT, a CXCR2 agonist, has shown promising activity for hematopoietic stem cell (HSC) mobilization with plerixafor in pre-clinical studies and healthy volunteers...Lenalidomide and anti-CD38 antibody were part of induction therapy in 92% (n = 23) and 24% (n = 6) of patients, respectively...74% (17 of 23) of grafts with this regimen were minimal residual disease negative by next generation flow cytometry. Graft composition for HSCs and immune cells were similar to a contemporaneous cohort mobilized with G-CSF and plerixafor."

Journal • P2 data • Hematological Malignancies • Multiple Myeloma • Oncology • Pain • Transplantation • CD34 • CXCR2

Daratumumab monotherapy versus active monitoring in patients with high-risk smoldering multiple myeloma: Aquila outcomes based on mayo 2018/IMWG 2020 risk stratification, IMWG 2020 plus cytogenetic criteria, and age (ASH 2025) - P3 | "Similarity was also observed inTEAE incidence rate when looking into <65, 65 to <75, and ≥75 y subgroups (82.7%, 81.1%, and 87.5% withActMon; 96.2%, 98.5%, and 95.2% with Dara); however, serious TEAEs were more frequently observed inolder ActMon pts (12.2%, 18.9%, and 50.0% with ActMon; 24.8%, 35.8%, and 28.6% with Dara).Across all pts treated/monitored in AQUILA, 23 (11.9%) and 41 (20.9%) pts in the Dara and ActMon arms,respectively, received autologous stem cell transplant as part of their first tx after progressing to activeMM, with very limited plerixafor use (Dara, 3 [1.6%] vs ActMon, 9 [4.6%]). In this analysis, pts with high-risk SMM from the phase 3 AQUILA study treated with Dara monotherapyexperienced long-term PFS benefit across IMWG 2020 subgroups, with the most pronounced benefit inthe high-risk subgroup. No notable differences in PFS or safety were observed across age subgroups.Early Dara tx for high-risk SMM did not have a detrimental impact on..."

Clinical • Monotherapy • Hematological Malignancies • Multiple Myeloma • Smoldering Multiple Myeloma • CD34

Role of Targeted Immune Therapies in Relapsed/Refractory Hodgkin Lymphoma—A Multicenter, Lower-Middle-Income Country Experience From Various Transplant Centers in Pakistan (SOHO 2026) - "Successful stem cell mobilization was achieved with GCSF alone in 91.1% of patients, whereas 11.11% required a combination of G-CSF and plerixafor. Brentuximab vedotin and nivolumab are both effective and well-tolerated in a young, heavily pretreated cohort of patients with R/R HL in Pakistan. Survival outcomes were improved with manageable toxicity profiles as bridging treatments prior to autologous stem cell transplantation, with encouraging posttransplant results. auto-SCT: autologous stem cell transplantation, CR: complete response, CTCAE: Common Terminology Criteria for Adverse Events, EOT: end of therapy, GCSF: granulocyte colony-stimulating factor, HL: Hodgkin lymphoma, LMIC: low- and middle-income country, OS: overall survival, PD, progressive disease, PET: positron emission tomography, PFS: progression-free survival, PR: partial response, SD: stable disease."

Clinical • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Stem cell mobilization yields with daratumumab and lenalidomide-containing quadruplet induction therapy in newly diagnosed multiple myeloma: findings from the MASTER and GRIFFIN trials. (PubMed, Transplant Cell Ther) - "Four cycles of daratumumab and lenalidomide-based quadruplet induction therapy had minimal impact on stem cell mobilization and allowed predictable stem cell harvesting and engraftment in all patients who underwent ASCT. Upfront plerixafor strategy may be considered, but many patients were successfully collected with the G-CSF alone or using rescue plerixafor."

Journal • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Efficacy and safety of Isa-KRd induction before response-adapted consolidation in transplant eligible newly diagnosed multiple myeloma: an interim analysis of the IFM2020-02 MIDAS study. (IMW 2024) - P3 | "The phase 3 IFM2020-02 MIDAS (Minimal Residual Disease [MRD] Adapted Strategy) study (NCT04934475) assessed an MRD-driven consolidation and maintenance strategy after isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) induction...Peripheral stem cells (PSCs) were collected after 3 cycles, G-CSF and plerixafor mobilization... Isa-KRd induction resulted in deep responses and high MRD negativity rates; and permitted PSCs to be collected for ASCT(s). No new safety signals were observed. The ongoing MIDAS study needs further follow-up for final analysis."

Clinical • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Pain • Thrombocytopenia • Transplantation • CD34

Combination of CXCR4 antagonist and anti-PD1 therapy results in significant mobilization and increased infiltration of myeloid cells into the metastatic liver microenvironment of PDAC (AACR 2023) - P2 | "Based on these findings, we have conducted a phase 2 trial evaluating the effects of plerixafor, a CXCR4 antagonist, and cemiplimab, a PD1 inhibitor antibody, in patients with metastatic PDAC who have progressed after one line of systemic chemotherapy (NCT04177810). This implicates a potential mode of resistance against CXCR4-targeted therapies. Furthermore, these observations reinforce the value of ongoing research efforts in the field to subvert the recruitment or immunosuppressive function of myeloid cells, which would be particularly relevant in the setting of CXCR4 antagonism."

IO biomarker • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CCR2 • CD34 • CXCL12 • CXCR2

SCDHCT: Reduced Intensity Transplantation for Severe Sickle Cell Disease (clinicaltrials.gov) - P2 | N=46 | Active, not recruiting | Sponsor: St. Jude Children's Research Hospital | Suspended ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Hematological Disorders • Sickle Cell Disease • Transplantation

Genetic Engineering of Hematopoietic Progenitor Stem Cells for Targeted IFN-α Immunotherapy Reprogramming the Solid Tumor Microenvironment: A First-in-Man Study in Glioblastoma Multiforme (NCT03866109) (ASH 2023) - P1/2 | "Autologous CD34+ HSPC are mobilized with lenograstim and plerixafor, collected by apheresis, purified and ex vivo modified with a lentiviral vector. So far, up to 3 million Temferon cells/kg have been co-administered with a fixed dose of non-manipulated CD34+ supporter cells following a sub-myeloablative conditioning regimen (Thiotepa + BCNU or Busulfan or Busulfan alone)... These data show that Temferon is safe and biologically active at the tumor site and favors anti-tumor immunity. The results provide initial evidence of Temferon's potential to modulate the TME of GBM patients and to counteract disease progression and improve the survival of uMGMT GBM patients."

Biomarker • IO biomarker • Tumor microenvironment • Brain Cancer • CNS Tumor • Gene Therapies • Glioblastoma • Oncology • Solid Tumor • CD34 • CD8 • IFNA1 • MGMT • PTPRC

Stem Cell Mobilization After Two Cycles in the Anti-Cd38 Era: Does Earlier Timing Improve Apheresis Outcomes? (IMS 2026) - "However, early mobilization after 2 cycles was not associated with differences in mobilization or apheresis outcomes, including poor mobilizer rate (46.3 vs 36%; OR 1.53, 95% CI 0.72-3.24; p=0.27) plerixafor use (43.3% vs 38%; OR 1.53, 95% CI 0.59-2.63; p=0.56), peripheral blood CD34 concentration (19.99 vs 20.79/µL; p=0.77), CD34/Kg yield (3.23 vs 3.12x10 6 /Kg; p=0.65), >1 apheresis day (36.4 vs 32%; OR 1.21, 95% CI 0.56-2.64; p=0.62) or mobilization failure (4.5 vs 8%; OR 0.54, 95% CI 0.12-2.52; p=0.43)... In the anti-CD38 era, stem cell mobilization remains an effective procedure. Our results suggest early mobilization after 2 cycles may reduce G-CSF requirements prior to apheresis, without impacting procedural outcomes or need for rescue mobilization strategies."

Hematological Malignancies • Multiple Myeloma • CD34 • CSF3

Intermediate Dose of Arac as Safe and Effective Savage Therapy for Multiple Myeloma Poor Mobilizers (IMS 2026) - "Granulocyte-colony stimulating factor (G-CSF) with or without cyclophosphamide (Cy) and on demand plerixafor is currently a standard regimen for HSCs mobilization in MM patients, but the HSC collection success rate is still less than 100% (Mina R et al, Haematologica , 2024). We can therefore conclude that, even if in our limited number of poor mobilizers, mobilization with intermediate dose of Ara-C+G-CSF and plerixafor was adequate in all patients and it could be considered an effective and safe savage mobilizing strategy."

Hematological Malignancies • Infectious Disease • Multiple Myeloma • CD34

Preharvest Platelet Counts Predict Response To Plerixafor in Pediatric Patients Undergoing Autologous Stem Cell Transplant. (PubMed, Indian J Hematol Blood Transfus) - "This finding suggests that baseline platelet counts can help predict the effectiveness of plerixafor-mediated stem cell mobilization in this patient population. Further larger prospective studies are warranted to validate these findings and identify additional factors influencing plerixafor response in pediatric patients."

Journal • Bone Marrow Transplantation • Oncology • Pediatrics • Transplantation • CD34

Second autologous hematopoietic stem cell transplantation in multiple myeloma. (PubMed, Indian J Cancer) - "ASCT2 is a feasible salvage strategy in selected Indian patients with MM, yielding favorable outcomes with acceptable toxicity."

Journal • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Transplantation • SLC1A5

Mgta-145 + Plerixafor Provides GCSF-Free Rapid and Reliable Hematopoietic Stem Cell Mobilization for Autologous Stem Cell Transplant in Patients with Multiple Myeloma: A Phase 2 Study (TCT-ASTCT-CIBMTR 2022) - P2 | "At last follow-up, 18 patients have completed transplant with MGTA-145 graft, with melphalan 200 mg/m 2 in 15 patients. This is the first study to evaluate the novel G-CSF-free regimen of MGTA-145 + plerixafor for HSC cell mobilization in hematologic cancers. 88% patients met the primary endpoint. The regimen was well tolerated."

Clinical • P2 data • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Musculoskeletal Pain • Oncology • Pain • Transplantation • CD34 • CSF3 • CXCR2 • THY1