Clinical trial · Interventional
Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy
Phase 1/2 Study to Evaluate the Safety, Feasibility, and Efficacy of FP-1201 (Intravenous Interferon-Beta-1a) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed before opening to accrual, no participants enrolled
Summary
Brief summary (as posted)
This phase I/II trial tests the safety and how well intravenous interferon-beta-1a (FP-1201) works in preventing toxicities after CD19-directed chimeric antigen receptor (CAR) T-cell therapy in patients with B-cell cancers that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Interferon beta-1a is in a class of medications called immunomodulators. It works by protecting the lining of blood vessels, and preventing brain inflammation. Giving FP-1201 may prevent cytokine release syndrome (CRS) and immune effector cell associated-neurotoxicity syndrome (ICANS) toxicities in patients receiving CD19 CAR T-cell therapy with recurrent or refractory B-cell malignancies.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent B Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Recurrent B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
| Refractory B Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Refractory B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Bone Marrow Aspiration | Procedure | — | UNRESOLVED |
| Bone Marrow Biopsy | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Echocardiography | Procedure | — | UNRESOLVED |
| Interferon Beta-1A | Biological | Interferon Beta-1a | ALIAS |
| Lumbar Puncture | Procedure | — | UNRESOLVED |
| Multigated Acquisition Scan |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention (interferon beta-1A [FP-1201])
- description
- Patients undergo leukapheresis prior to treatment and receive FP-1201 IV for 3 days every 24 hours from day -3 through day -1 or for 5 days every 24 hours from day -5 through day -1 or on day -5, day -3, and day -1. Patients may receive lymphodepletion chemotherapy with either cyclophosphamide IV and fludarabine IV on days -5, -4, -3 followed by axi-cel IV or brexu-cel IV on day 0 or fludarabine IV over 30 minutes on days -4, -3, and -2 and cyclophosphamide IV over 60 minutes on day -2 followed by brexu-cel IV on day 0. Patients undergo x-ray imaging and ECHO or MUGA during screening. Patients also undergo CT or PET/CT as well as LP for CSF collection and/or bone marrow aspiration and biopsy as clinically indicated during screening and follow-up. Patients undergo blood sample collection on study and during follow-up as well as a tissue biopsy during screening and follow-up.
- interventionNames
- Biological: Interferon Beta-1A
- Procedure: X-Ray Imaging
- Procedure: Echocardiography
- Procedure: Multigated Acquisition Scan
- Procedure: Computed Tomography
- Procedure: Positron Emission Tomography
- Procedure: Lumbar Puncture
- Procedure: Bone Marrow Aspiration
- Procedure: Bone Marrow Biopsy
- Procedure: Biospecimen Collection
- Procedure: Biopsy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be 18 years of age or older * Karnofsky performance status of \>= 60% * Participants eligible for treatment with axi-cel or brexu-cel * Negative serum pregnancy test within 2 weeks of enrollment for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year * Fertile male and female participants must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last dose of FP-1201 * Ability to understand and provide informed consent Exclusion Criteria: * Known hypersensitivity to natural or recombinant interferon beta, albumin or any other component of the formulation * Estimated creatinine clearance (Cockcroft and Gault) =\< 60 mL/min * Significant proteinuria defined as 2+ or 3+ proteinuria or urinary protein \>= 1g/24h * Severe hepatic dysfunction defined as group C of the National Cancer Institute Organ Dysfunction Working Group hepatic impairment criteria (total bilirubin \> 3x upper limit of normal \[ULN\] with any aspartate aminotransferase \[AST\] or alanine transaminase \[AL\]T value), or AST or ALT \> 3x ULN, unless due to malignancy or Gilbert's syndrome in the opinion of the principal investigator (PI) or designee * Participants with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing, as clinically indicated. Those with an forced expiratory volume in the first second (FEV1) of \< 50 % of predicted or diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected) \< 40% will be excluded * Significant cardiovascular abnormalities as defined by any one of the following: * New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension * Uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of \< 35% * Uncontrolled serious and active infection * Corticosteroid use (\> 20mg/day of prednisone, or equivalent) within 7 days prior to first FP-1201 administration
References
Publications (0)
Data not yet available