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IVIG for Infection Prevention After CAR-T-Cell Therapy

StatusRecruiting
PhasePhase 2
Started2024-06-10
View on ClinicalTrials.gov ↗

Amendment history

2026-06-25
Study Status, Study Description, Arms and Interventions, Eligibility v20
Eligibility criteria+180 characters
[...] b) Serum total IgG < 600mg/dL within the prior three months Note, if there are additional results ≥ 600 mg/dL within the prior three months, but the patient is receiving IVIG, they remain eligible SUBSEQUENT INFUSIONS: Received an FDA-approved CD19-CAR T-ce [...] r persistence or relapse of the patient's primary malignancy for which they underwent CARTx SUBSEQUENT INFUSIONS: Receipt of bone marrow transplant (allogeneic or autologous) after CARTx SUBSEQUENT INFUSIONS: Any serious adverse event (SAE), clin [...]
Study description+116 characters
[...] lying disease, or subsequent hematopoietic cell transplant. Doses 3, 4, and 5 are highly encouraged but not required. Patients also undergo blood sample collection throughout the [...] lying disease, or subsequent hematopoietic cell transplant. Doses 3, 4, and 5 are highly encouraged but not required. Patients also undergo blood sample collection throughout the [...]
2026-04-20
Study Status v19
Primary completion pushed: 2027-07-31 → 2028-07-31
2026-04-01
Study Status, Contacts/Locations v18
Study sites6→7
2026-01-28
Study Status, Contacts/Locations v17
Study sites5→6
2025-10-13
Study Status v16
Re-verified, no change to tracked fields
Show 15 earlier versions
2025-10-01
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 5 sites
2025-04-18
Study Status, Conditions, Eligibility v14
Eligibility criteria+70 characters
[...] (FDA)-approved CD19-CAR T-cell product for the treatment of lymphomahematologic malignancies. Patients receiving an FDA-approved product are eligible ev [...] ti-tumor treatment such as acalabrutinib) Serum total IgG < 500mg600mg/dL within the prior three months SUBSEQUENT INFUSIONS: Rece [...] n FDA-approved CD19-CAR T-cell product for the treatment of lymphomahematologic malignancies Exclusion Criteria: SelectivePrimary congenital selective IgA deficiency Prior serious adverse event/s related to int [...] eeting criteria for grade 3 or higher SUBSEQUENT INFUSIONS: SelectivePrimary congenital selective IgA defici [...]
2024-12-26
Study Status, Study Description, Outcome Measures, Eligibility v13
Eligibility criteria-1 characters
[...] proved CD19-CAR T-cell product for the treatment of lymphoma. Exclusion Criteria: Selective IgA deficiency Prior serious [...]
2024-10-16
Study Status, Contacts/Locations v12
Study sitesdetails revised at 3 of 5 sites
2024-06-27
Study Status, Eligibility v11
Eligibility criteria-2 characters
[...] anti-tumor treatment such as acalabrutinib) Serum total IgG =< 400 mg500mg/dL within the prior three months SUBSEQUENT INFUSIONS: Rece [...]
2024-06-10
Study Status v10
Re-verified, no change to tracked fields
2024-05-10
Study Status v9
Start date2024-05-08→2024-06-10
2024-04-08
Study Status v8
Start date2024-04-07→2024-05-08
2024-03-07
Study Status v7
Start date2024-03-07→2024-04-07
2024-02-08
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility v6
Start date2024-02-29→2024-03-07
InterventionsAnti-CD19-targeting CAR-T Cells (Biological), Biospecimen Collection (Procedure), Electronic Health Record Review (Other), Immune Globulin…→Anti-CD19 CAR T Cells Preparation (Biological), Biospecimen Collection (Procedure), Electronic Health Record Review (Other), Immune…
Eligibility criteria+537 characters
[...] proved CD19-CAR T-cell product for the treatment of lymphoma. Patients receiving an FDA-approved product are eligible even if the product is being administered as part of a clinical trial or expanded access program (e.g., product is 'out of specification'; concomitant anti-tumor treatment such as acalabrutinib) Serum total IgG =< 400 mg/dL within the prior three months SUBSEQUENT INFUSIONS: Received an FDA-approved CD19-CAR T-cell product for the treatment of lymphoma. Exclusion Criteria: Selective IgA deficiency Prior serious a [...] e best interest of the patient to participate in this study SUBSEQ [...] [...]
Secondary endpoints10 to 11 entries
CAR T-cell persistenceexpansion: area under the curve (AUC) CAR T-cell persistence
2024-01-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start date2024-03-01→2024-02-29
Study sitesdetails revised at 5 of 5 sites
2024-01-24
Study Status v4
Re-verified, no change to tracked fields
2023-12-07
Study Status v3
Start date2023-12-01→2024-03-01
2023-08-10
Study Status, Contacts/Locations v2
Study sites1→5
2023-07-21
Study Status, Outcome Measures v1
Secondary endpoints11 to 10 entries
CAR T-cell expansion
2023-07-17
Original filing
This phase II trial compares the effects of immunoglobulin replacement therapy with a placebo for preventing infectious complications in patients receiving CD19 chimeric antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in patients who receive CD19 CAR-T cell therapy. This is a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high. Immunoglobulin replacement therapy works by replacing the body's immunoglobulin G (IgG) antibodies with donor blood product derived IgG antibodies that may help prevent infection. IgG antibodies are often depleted as a result of CAR-T therapy. Giving immunoglobulin replacement therapy may prevent infectious complications in patients receiving CD19 CAR-T cell therapy.
Trial Details
NCT Number NCT05952804
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Takeda, National Cancer Institute (NCI)
Conditions Hematologic Malignancies
Enrollment 150 participants
Start Date 2024-06-10
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-29