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B-Cell NeoplasmPhase 1NCT04410900

Vaccine Responsiveness After CAR-T Cell Therapy

A Phase 1 study testing Wistar Rabies Virus Strain PM-1503-3M Vaccine and Biospecimen Collection in people with B-Cell Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial will use the inactivated rabies virus vaccine to assess immune function in patients who previously underwent B cell targeted chimeric antigen receptor-modified T cell immunotherapy (CARTx). A cohort of healthy volunteers will also be enrolled as a comparator group. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
B-Cell Neoplasm
What is being tested?
Wistar Rabies Virus Strain PM-1503-3M Vaccine and Biospecimen Collection
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
3 Aug 2020to 31 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • CARTx RECIPIENTS: Patients must be capable of understanding and providing a written informed consent
  • CARTx RECIPIENTS: Patients must be 18 years of age or older, of any gender, race or ethnicity
  • CARTx RECIPIENTS: Patients must have had relapse-free survival for >= 6 months after receiving CARTx for B-cell malignancies
  • CARTx RECIPIENTS: Platelet count > 30,000 / mm^3
  • HEALTHY CONTROLS: Patients must be capable of understanding and providing a written informed consent
  • HEALTHY CONTROLS: Patients must be 18 years of age or older, of any gender, race or ethnicity

Who cannot join

  • CARTx RECIPIENTS: Patients who have received a hematopoietic cell transplant after CARTx
  • CARTx RECIPIENTS: Previously received 1 or more rabies vaccines prior to the first vaccine visit
  • CARTx RECIPIENTS: Patients who have received lymphodepleting therapies after CARTx and within the past 6 months
  • CARTx RECIPIENTS: Patients with signs or symptoms of active infection
  • CARTx RECIPIENTS: Patients who are pregnant or breastfeeding
  • CARTx RECIPIENTS: Patients with previous known allergies to any component of the vaccine
Show all 15Show fewer
  • CARTx RECIPIENTS: Patients who have previously experienced a reaction to any vaccine that required medical attention
  • CARTx RECIPIENTS: Study participants who report a severe adverse event following the first rabies vaccine will not be eligible for a second dose
  • CARTx RECIPIENTS: Receiving corticosteroids > 0.5 mg/kg/day prednisone equivalence in the 7 days prior to first or second vaccination
  • HEALTHY CONTROLS: Previously received 1 or more rabies vaccines
  • HEALTHY CONTROLS: Chronic illness
  • HEALTHY CONTROLS: Signs or symptoms of active infection
  • HEALTHY CONTROLS: Pregnant or breastfeeding
  • HEALTHY CONTROLS: Patients with previous known allergies to any component of the vaccine
  • HEALTHY CONTROLS: Previous reaction to a vaccine that required medical attention

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Rabies Vaccination to Assess Vaccine Responsiveness After B Cell Targeted CAR-T Cell Therapies

This phase I trial will use the inactivated rabies virus vaccine to assess immune function in patients who previously underwent B cell targeted chimeric antigen receptor-modified T cell immunotherapy (CARTx). A cohort of healthy volunteers will also be enrolled as a comparator group. CARTx is a new treatment for patients with B-cell malignancies (cancer of the B-cells), and the long-term effects of CARTx on immune function are not yet well understood. Learning more about vaccine responsiveness in patients who previously underwent CARTx may help doctors better understand immune function. The findings will guide evidence-based strategies for infection prevention to improve outcomes in this rapidly growing population of high-risk individuals.

Read the detailed description

STUDY DESIGN:

This study will be a prospective, open-label clinical trial of primary and secondary vaccination with the inactivated rabies vaccine in patients treated with CARTx for B cell malignancies and healthy individuals. The target enrollment for this trial is 43 CARTx recipients and 10 healthy controls. The study is open to anyone regardless of gender or ethnicity.

OUTLINE:

BOLUS COHORT: Patients receive the inactivated rabies vaccine intramuscularly (IM) on day 1 and 6-10 weeks later. Patients also undergo a blood collection prior to each vaccine, and at approximately 1, 2, and 4 weeks after each vaccination. A final blood collection occurs 6 months after the first immunization. This will include up to 31 participants.

FRACTIONAL DOSE COHORT: Patients receive the inactivated rabies vaccine fractionated primary dose IM on days 1, 3, 7, 10, 14, and 17 and the second dose 6-10 weeks later. Patients also undergo a blood collection prior to each vaccine, and at approximately 1, 2, and 4 weeks after each vaccination. A final blood collection occurs 6 months after the first immunization. This will include up to 12 participants.

Conditions
B-Cell Neoplasm
Being tested
Wistar Rabies Virus Strain PM-1503-3M Vaccine, Biospecimen Collection
Keywords
CAR T cells, infection, vaccine, immunity
Medical subject headings
Lymphoma, B-Cell, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wistar Rabies Virus Strain PM-1503-3M VaccineBiological

    Also called Imovax Rabies

    Given IM

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected

    Undergo collection of blood samples

Study groups in NCT04410900
Study groupRoleWhat they receive
Experimental (anti-rabies vaccine, collection of blood)ExperimentalBOLUS COHORT: Patients receive the inactivated rabies vaccine IM on day 1 and 6-10 weeks later. Patients also undergo a blood collection prior to each vaccine, and at approximately 1, 2, and 4 weeks after each vaccination. A final blood collection occurs 6 months after the first immunization. FRACTIONAL DOSE COHORT: Patients receive the inactivated rabies vaccine fractionated primary dose IM on days 1, 3, 7, 10, 14, and 17 and the second dose 6-10 weeks later. Patients also undergo a blood collection prior to each vaccine, and at approximately 1, 2, and 4 weeks after each vaccination. A final blood collection occurs 6 months after the first immunization.
Receives: Biological: Wistar Rabies Virus Strain PM-1503-3M Vaccine; Procedure: Biospecimen Collection
Control (anti-rabies vaccine, collection of blood)Active comparatorPatients receive anti-rabies vaccine IM on day 1 and 6-10 weeks later. Patients also undergo collection of blood samples at baseline, and at approximately 1, 2, and 4 weeks after each vaccination. There will be an additional blood draw 6 months (+/- 14 days) after the first immunization.
Receives: Biological: Wistar Rabies Virus Strain PM-1503-3M Vaccine; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with positive vaccine response

    This will be defined as a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/ml at week 4 post-secondary immunization. This RVNA titer is considered to be evidence of an adequate immune response by the World Health Organization. Will estimate with 95% confidence intervals.

    Measured: 4 weeks after the secondary vaccination

Secondary outcomes (4)

  1. Proportion of participants with sustained vaccine response

    This will be defined as a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/ml at 6 months following the primary vaccination in participants who also receive secondary vaccination per-protocol

    Measured: 6 months after the primary vaccination

  2. Longitudinal rabies virus neutralizing antibody (RVNA) titers

    Will compare quantitative levels of RVNA (log10 IU/mL) between CAR-T cell therapy and healthy participants at weekly intervals after each vaccination and at 6 months after primary vaccination.

    Measured: From baseline (prior to primary vaccination) through 6 months after primary vaccination based on measurements at weeks 0, 1, 2, 4, 6, 7, 8, 10, and 24.

  3. Longitudinal rabies virus binding IgM antibody titers

    Will compare quantitative levels of anti-rabies virus IgM between CAR-T cell therapy and healthy participants at weekly intervals after each vaccination and at 6 months after primary vaccination.

    Measured: From baseline (prior to primary vaccination) through 6 months after primary vaccination based on measurements at weeks 0, 1, 2, 4, 6, 7, 8, 10, and 24.

  4. Longitudinal rabies virus binding IgG antibody titers

    Will compare quantitative levels of anti-rabies virus IgG between CAR-T cell therapy and healthy participants at weekly intervals after each vaccination and at 6 months after primary vaccination.

    Measured: From baseline (prior to primary vaccination) through 6 months after primary vaccination based on measurements at weeks 0, 1, 2, 4, 6, 7, 8, 10, and 24.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start3 Aug 2020
  3. Primary completion28 Apr 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410900
Sponsor's protocol ID
RG1007238
Other IDs
NCI-2020-03444, 10411
Status last verified
Sep 2025
First submitted
28 May 2020
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in a future article will be shared, after deidentification (text, tables, figures, and appendices).

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Wistar Rabies Virus Strain PM-1503-3M Vaccine and Biospecimen Collection in people with B-Cell Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with positive vaccine response (time frame: 4 weeks after the secondary vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04410900.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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