Clinical trial · Interventional
A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs
A Pilot Study of CDX-301 (rhuFlt3L) With or Without Plerixafor for the Mobilization and Transplantation of Allogeneic Blood Cell Grafts in HLA-Matched Donor/Recipient Sibling Pairs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, multicenter, prospective pilot study of CDX-301 with or without plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol specified hematologic malignancies (recipients) will be enrolled.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Acute Myelogenous Leukemia (AML) | Acute Myeloid Leukemia | ALIAS | 0.85 |
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | CURATED_BROADER | 0.80 |
| For Donors | — | UNRESOLVED | — |
| For Recipients | — | UNRESOLVED | — |
| Hodgkins Disease (HD) | Hodgkin Lymphoma | ALIAS | 0.85 |
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkins Lymphoma (NHL) | Non-Hodgkin Lymphoma | ALIAS |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDX-301 | Drug | — | UNRESOLVED |
| CDX-301 and plerixafor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CDX-301
- interventionNames
- Drug: CDX-301
- type
- EXPERIMENTAL
- label
- CDX-301 and plerixafor
- interventionNames
- Drug: CDX-301 and plerixafor
Primary outcomes (1)
- measure
- Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors.
- timeFrame
- 1 Year
- description
- Safety and tolerability will be evaluated by comparing the treatment regimens in regards to vital sign measurements, physical examinations and adverse event reporting.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Donors: * Read, understood and provided written informed consent and willing to comply with all study requirements and procedures * 6 out of 6 HLA-matched sibling * Negative test for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C * Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures * Subjects should be in generally good health and without significant medical conditions, based upon pre-study medical history, physical examination, electrocardiogram (ECG), chest X- ray, and laboratory tests * Meets all criteria to serve as a mobilized blood cell donor in accordance with all applicable individual Transplant Center criteria Recipient: * Read, understood and provided written informed consent and willing to comply with all study requirements and procedures * 6 out of 6 HLA-matched sibling * Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures Diagnosis of one of following: * Acute Myelogenous Leukemia (AML) in 1st remission or beyond * Acute Lymphoblastic Leukemia (ALL) in 1st remission or beyond * Chronic Myelogenous Leukemia (CML) * Chronic Lymphoblastic Leukemia (CLL), relapsing after at least one prior regimen * Myelodysplastic Syndrome (MDS), either intermediate 1,2, or high risk by IPI Scoring System or transfusion dependent * Non-Hodgkins Lymphoma (NHL) or Hodgkins Disease (HD) in 2nd or greater complete remission, partial remission, or in relapse * Meets all criteria to serve as a transplant recipient in accordance with all applicable individual Transplant Center criteria Exclusion Criteria: Donors: * Unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing * Prior treatment with any rhuFlt3L product * Any vaccination within 4 weeks prior to CDX-301 dosing * Donation of blood within 8 weeks, or donation of plasma within 2 weeks prior to CDX-301 dosing * Any experimental treatment within 4 weeks prior to CDX-301 dosing * Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months prior to CDX-301 dosing. * History of first degree relatives with primary or secondary immunodeficiency to include type 1 diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma or psoriasis * History of tuberculosis infection * Herpes zoster within 3 months prior to starting study drug * Pregnant or nursing Recipient: * Unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing * Prior allogeneic transplant * More than one prior autologous transplant * Prior treatment with any rhuFlt3L product * Any vaccination within 4 weeks prior to transplant * Uncontrolled infection at the time of the transplant conditioning regimen * Pregnant or nursing * Any condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the study outcome
References
Publications (0)
Data not yet available