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Autologous FL vaccine

Phase 1

Lymphoma, Follicular | Monoclonal antibody | Oncology |Icon Plc|Last Updated: Jan 30, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Autologous FL vaccine · 1 trial · 1 indication

Phase 1 1
NCT01022255Autologous Vaccine for Follicular LymphomaLymphoma, Follicular
COMPLETED28 Analytics
PHASE1COMPLETED
Autologous Vaccine for Follicular Lymphoma
Lymphoma, Follicular
NCT0102225528
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Study Endpoints

Primary Endpoints

Proportion of patients with toxicities as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI/CTCAE) version 3.0 grade >/= 3 to the magnICON generated idiotype (Id) vaccine
One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)

Secondary Endpoints

Assessment of humoral idiotype-specific immune responses
One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)
Assessment of cellular idiotype-specific immune responses
One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)
Long-term safety/tolerability as determined by the proportion of patients with toxicities as assessed by the FDA CBER Guidance for Industry Toxicity Grading Scale in Preventive Vaccine Clinical Trials and the NCI/CTCAE version 4.02 grade >/= 3
Up to the conclusion of a 12 cycle vaccination phase (month 16)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Autologous FL vaccineBIOLOGICAL1.0 mg of vaccine subcutaneously (s.c.) on Day 1, and followed by 125 µg GM-CSF s.c. at Day 1 -4, monthly until 8th vaccination, bimonthly until 12th vaccination (month 16)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Subjects with histologically proven follicular lymphoma (grade 1, 2, or 3a), in clinical relapse/progression requiring treatment * Subjects must have had first line treatment consisting of rituximab with or without rituximab maintenance therapy (i.e. rituximab monotherapy, R-C...

Countries:United States
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Frequently asked questions about Autologous FL vaccine

What is Autologous FL vaccine used for?

Autologous FL vaccine is an investigational cancer vaccine being studied for the treatment of follicular lymphoma, a type of non-Hodgkin lymphoma. It is designed to use a patient's own tumor material to stimulate an immune response against the cancer. The vaccine is currently in Phase 1 clinical development.

Who is developing Autologous FL vaccine?

Autologous FL vaccine is being developed by Icon Plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ICLR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational vaccine for follicular lymphoma.

What phase is Autologous FL vaccine in?

Autologous FL vaccine is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. A Phase 1 trial has been completed, which focused on assessing the safety and tolerability of the vaccine in patients with follicular lymphoma.

What clinical trials is Autologous FL vaccine in?

Autologous FL vaccine has been studied in one clinical trial with the identifier NCT01022255, titled 'Autologous Vaccine for Follicular Lymphoma'. This was a Phase 1, uncontrolled study conducted in the United States, enrolling 28 adult patients with follicular lymphoma. The trial has been completed.

Is Autologous FL vaccine a monoclonal antibody?

Autologous FL vaccine is classified as a monoclonal antibody modality, but it is specifically an autologous vaccine. This means it is prepared from the patient's own tumor cells or antigens to trigger an immune response. It is being investigated for the treatment of follicular lymphoma.