ClinicalTrials.gg
Active, not recruitingNCT03361852Updated Mar 25, 2026

Personalized Neoantigen Cancer Vaccine + Pembrolizumab After Rituximab for Follicular Lymphoma

A Phase 1 interventional study of Rituximab and Neo Vax in Follicular Lymphoma, sponsored by Dana-Farber Cancer Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,185 studies in Lymphoma, Follicular with a site in United States — 127 open to participants now, 216 under way, 20 of them phase 3. Lymphoma, Follicular · United States.

Planned enrollment
743rd of 1,015
20 · median 38
Started
2022
with 35 others
Phase 1
363 of 1,185
35 open now
Primary completion
2026-12
later than 60 of 215 live
Registered
868th of 1,185
by date

Among the 1,185 studies in Lymphoma, Follicular with a site in United States, this one is the 743rd largest by planned enrollment of the 1,015 interventional ones that give a count, is one of 36 that started in 2022, is one of 363 in phase 1, reaches primary completion later than 60 of the 215 other live ones, and was the 868th registered.

Lymphoma, Follicular

1,891 studies on the registry are indexed under Lymphoma, Follicular; 289 are open to participants now.

Browse Lymphoma, Follicular studies →

Open to participants now

127 of the 1,185 studies in Lymphoma, Follicular with a site in United States are open now. Recruiting first, the newest first:

122 more — sign in →

All 127 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 225 Lymphoma, Follicular studies recruiting now, 158 (70%) set no upper age limit and 39 (17%) stop at 75 or younger; 33 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This research study is studying a novel type of FL vaccine as a possible treatment for follicular lymphoma (FL).

The agents involved in this study are:

  • Rituximab
  • Personalized NeoAntigen vaccine
  • Poly-ICLC
  • Pembrolizumab
Read the detailed description

This research study is a Pilot Study, which is the first time investigators are examining the Personalized Neoantigen Vaccine (NeoVax) in patients diagnosed with follicular lymphoma. The FDA (the U.S. Food and Drug Administration) has not approved the Personalized Neoantigen Vaccine as a treatment for any disease.

Patients will receive 4 weekly doses rituximab (a CD20 monoclonal antibody) during NeoVax manufacturing (see below). Patients who have stable disease or achieve a response with rituximab therapy will next receiving NeoVax alone (first 5 patients) or NeoVax in combination with pembrolizumab (a PD-1 monoclonal antibody).

The purpose of this study is to determine if it is possible to make and safely administer a vaccine against FL by using information gained from specific genetic characteristics of the participant's own FL cells. The investigators plan to analyze the specific genetic characteristics of the participant's own FL cells and use that information to produce proteins that may help the participant's immune system recognize and fight FL cells.

This vaccine has already been tested in clinical trials in patients with advanced melanoma (a type of skin cancer) and glioblastoma (a type of brain cancer). The current study will examine the ability of the vaccine to stimulate the participant's immune system when given at several different timepoints, and will examine the participant's blood cells for signs that the FL has changed or decreased.

FL cells will be obtained from a tumor biopsy. The genetic material contained in the FL cells will be examined for the presence of tumor-specific mutations. This information will be used to prepare small protein fragments, which are called "peptides." The vaccine will consist of up to 20 of these peptides as well as a drug called Poly-ICLC. A peptide from the tetanus vaccine will also be included to boost the immune response.

Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity. Poly-ICLC binds proteins on the surface of certain immune cells to make it appear as if a virus is present. When the cells detect the vaccine, they think it is a virus and turn on the immune system. Poly-ICLC will be mixed with NeoAntigen peptides and administered as an injection given underneath the skin. Poly-ICLC is an investigational drug, meaning the FDA has not approved it as a treatment for any disease.

03

Conditions studied

  • Follicular Lymphoma

Keywords

  • Follicular Lymphoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of grade I-IIIA follicular lymphoma (pathology must be confirmed at DFCI/BWH)
  • Planned treatment with 4 weekly doses of rituximab.
  • No prior systemic therapy for follicular lymphoma; prior radiation with palliative or curative intent is allowed if radiation occurred more than 3 months prior to study entry
  • Patient must have by Cheson criteria
  • Age ≥ 18 years.
  • performance status \< 2.
  • Participants must have normal organ and marrow function as defined below:

    • > 9 gm/dl (ESAs or transfusion are not allowed) [greater than 8 gm/dl if there is lymphoma involvement of the bone marrow]
    • > 1000 (greater than 750 if there is lymphoma involvement of the bone marrow)
    • count >100,000 (greater than 50,000 if there is lymphoma involvement of the bone marrow]
    • (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) \< 1.5 x unless subject is on anticoagulation as long as PT or aPTT is within intended therapeutic range of anticoagulant used
    • (SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal (\< 5 x ULN if there are hepatic )
    • Creatinine \< 1.5 x ULN or measured or calculated ( can also be used in place of creatinine clearance) > 30 ml/min for subject with creatinine > 1.5 x institutional ULN
    • total less than institutional 1.5 x ULN (or a direct bilirubin \< ULN if total bilirubin is >1.5 x ULN)
  • The effects of NeoVax and poly-ICLC on the developing human fetus are unknown. For this reason, women of (WOCBP) must have a negative pregnancy test (serum) before entry onto the trial and within 7 days prior to start of study vaccination.
  • Female patients enrolled in the study, who are not free from menses for >2 years, post hysterectomy / oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of to prevent pregnancy or to abstain from sexual activity throughout the study, starting with visit 1 through 4 weeks after the last dose of study therapy. Approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception. Male participants need to agree to use an adequate method of contraception
  • Patient is agreeable to allow tumor (from peripheral blood, lymph node, or effusion) and normal tissue (from saliva) samples to be submitted for complete exome and transcriptome sequencing.
  • Ability to understand and the willingness to sign a written document.

Additional Inclusion Criteria for Treatment Registration

  • Participants must meet the following criteria (in addition to the above) to be eligible to proceed to receive vaccine treatment on the study:
  • At least 7 immunizing peptides can be designed
  • Continue to meet inclusion and exclusion criteria for Screening Registration (note: and serologies do not need to be repeated unless there is a clinical concern that an exposure has occurred since the screening phase).
  • Achieved a CR, PR, or SD with no residual mass greater than 5 cm per Lugano criteria following single agent rituximab per

Exclusion criteria

Exclusion Criteria:

  • Recovered from all AEs due to rituximab to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
  • Prior systemic therapy for follicular lymphoma with the exception of 4 weekly doses of rituximab as proscribed per protocol
  • Radiation with palliative or curative intent within 90 days of study screening
  • Has received prior therapy with an , anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Participants who are receiving any other agents.
  • Previous bone marrow or stem cell transplant
  • Concomitant therapy with or immunomodulatory agents; chronic use of systemic at doses of 10 mg of prednisone (or equivalent) for indications other than treatment of follicular lymphoma is acceptable. Use of higher doses of corticosteroids after initial registration is acceptable if tapered to 10 mg of prednisone (or equivalent) or les at least 7 days prior to NeoVax administration so long as the corticosteroids were not administered for follicular lymphoma.
  • Use of a non-oncology vaccine therapy for prevention of infectious diseases within 2 weeks prior to any NeoVax administration.
  • History of severe allergic reactions attributed to any vaccine therapy for the prevention of infectious diseases.
  • Active, known, or suspected disease or immunosuppressive conditions with the exception of vitiligo, type 1 diabetes, residual autoimmune-related hypothyroidism requiring hormone replacement, or psoriasis not requiring systemic treatment.
  • Progressive disease or stable disease with residual tumor mass > 5 cm by CT scan (measured as long axis) following 4 weekly doses of rituximab (for treatment phase only).
  • Any documented transformation to diffuse large B cell lymphoma or grade 3Bfollicular lymphoma.
  • Currently requiring chronic intravenous immunoglobulin G (IVIG)
  • Active infection with or C (see Study Calendar in Section 10 for screening assays).
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
  • Any underlying medical condition, psychiatric condition or social situation that in the opinion of the investigator would compromise study administration as per protocol or compromise the assessment of AEs.
  • Pregnant women are excluded from this study because personalized neoantigen peptides and poly-ICLC are agents with unknown risks to the developing fetus. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with personalized neoantigen peptides and poly-ICLC, nursing women are excluded from this study.
  • Individuals with history of an invasive are ineligible except for the following circumstances: a) individuals with a history of invasive malignancy are eligible if they have been disease -free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; b) individuals with the following cancers are eligible if diagnosed and treated: carcinoma in situ of the breast, oral cavity or cervix and basal cell or squamous cell carcinoma of the skin; c) individuals with prostate cancer managed with active surveillance that is not expected to limit their survival to \<10 years.
  • Participants with known CNS involvement
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to poly-ICLC.
  • -positive participants including those on combination antiretroviral therapy are ineligible because assessment of immunologic endpoints may be confounded by HIV-induced alterations in patient immune status and functio
Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Neo Vax

    * Neo Vax is injected into up to 4 different anatomic site. * NeoVax may be administered within +/- 1 day of the scheduled administration date for days 4 and 8, * Within +/-3 days of the scheduled administration date for days 15 and 22 * Within +/-7 days of days 78 and 134. * Participants will receive Rituximab weekly x 4 weeks per institutional standard

    Drug: Rituximab · Biological: Neo Vax

  • Experimental
    NeoVax and pembrolizumab

    * Neo Vax is injected into up to 4 different anatomic site. * NeoVax may be administered within +/- 1 day of the scheduled administration date for days 4 and 8, * Within +/-3 days of the scheduled administration date for days 15 and 22 * Within +/-7 days of days 78 and 134. * Patients will receive pembrolizumab every 3 weeks starting on day 78 * Participants will receive Rituximab weekly x 4 weeks per institutional standard

    Drug: Rituximab · Biological: Neo Vax · Drug: Pembrolizumab

Interventions

  • Rituximab is classified as a monoclonal antibody. It works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells

    Also known as: Rituxan

  • BiologicalNeo Vax

    Neo Vax is an experimental "viral mimic" and an activator of immunity.

  • Pembrolizumab is a monoclonal antibody that targets PD-1. It is a type of immunotherapy

06

What researchers measure

Primary outcomes

  1. Feasibility of Neovax following 4 weekly doses of rituximab assessed by the following

    The proportion of all enrolled patients for whom sequencing and analysis leads to identification of at least 7 actionable peptides to initiate vaccine production and, of the patients who generate at least 7 actionable peptides, the proportion for whom the time from sample collection to vaccine availability is less than 12 weeks.

    Time frame: 2 years

Secondary outcomes

  1. The proportion of participants who achieve an IFN-γ T cell response to one or more of the peptide pools

    The induction of IFN-γ T-cell response will be based on ELISPOT assessments taken prior to vaccine administration and at week 16 from both peripheral blood draws and bone marrow biopsies. The proportion of patients who achieve more than 55 SFU/106 PBMC or 3 times their baseline level will be presented with a 90% exact binomial confidence interval. Based on a cohort of size 10, the confidence interval will be no wider than 0.55. It is possible that the maximal response will occur at a different sampling time point or will vary between participants. Thus, this time point may vary from week 16.

    Time frame: 2 years

  2. The proportion of participants who convert from PR to CR

    The investigators will report the proportion of patients converting from SD to CR/PR or from PR to CR based upon Lugano criteria in a descriptive fashion.

    Time frame: 2 years

  3. The proportion of participants who convert from SD to PR/CR

    The investigators will report the proportion of patients converting from SD to CR/PR or from SD to PR or CR based upon Lugano criteria in a descriptive fashion.

    Time frame: 2 years

  4. Best Objective Response

    The investigators will report the best objective response (CR, PR, SD, or PD) based upon Lugano criteria in a descriptive fashion.

    Time frame: 2 years

  5. To describe the safety and tolerability of NeoVax following 4 weekly doses of rituximab in patient with previously untreated follicular lymphoma

    The investigators will report toxicity in a descriptive fashion using CTCAE version 4.0

    Time frame: 2 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2022 (actual). Primary completion is estimated for Dec 2026, 57 months after the start.

Of 89 non-industry phase 1 interventional studies under Lymphoma, Follicular, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 99. This study's planned 57 months is close to that.

Counting every sponsor, half of 173 studies reached it within 51 months; a quarter within 30 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2017
First posted
Dec 5, 2017
StartActual
Mar 14, 2022
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 26, 2033
Last update
Mar 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03361852
Responsible party
Reid Merryman, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Dec 5, 2017
Start date
Mar 14, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 26, 2033 (estimated)
Last update
Mar 25, 2026

Study contacts

Reid W Merryman, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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