Phase 1 Myeloma Trial, Recruiting NCT07377435 Sponsor: David Avigan Condition: Myeloma
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Phase 1 Myeloma Trial, Recruiting

NCT07377435
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are eligible to receive standard CAR T-cell therapy for multiple myeloma that has come back or stopped responding to treatment
  • People aged 18 or older
  • People who are reasonably able to carry out daily activities (assessed using a standard medical scale — confirm with trial site)
  • People whose bone marrow test, taken within 30 days before joining, shows 20% or more of a type of abnormal cell called plasma cells
  • People whose liver and kidneys are functioning well enough to meet specific levels set by the trial (confirm exact values with trial site)
  • People who agree to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) throughout the trial and for 6 months after treatment ends — this applies to both women and men who could potentially have children
  • People who are able to understand and sign a written consent form agreeing to take part

Additional criteria that must be met before receiving the vaccine part of the trial:

  • All serious side effects from CAR T-cell therapy must have resolved
  • The trial team must have been able to successfully produce at least 2 doses of the vaccine
  • The myeloma must not have gotten worse after CAR T-cell therapy
  • Daily functioning must still meet the same activity level as at the start (confirm with trial site)
  • Liver, kidney, blood cell, and platelet levels must still meet specific thresholds set by the trial (confirm exact values with trial site)
  • No other myeloma treatments must have been given after the CAR T-cell therapy

Who may not be able to join:

  • People who are currently taking part in another clinical drug trial
  • People who have a condition called Plasma Cell Leukemia
  • People who have active, uncontrolled HIV, hepatitis C, or hepatitis B infections
  • People who have had a heart attack within the last 6 months, or who have serious heart conditions such as severe heart failure, uncontrolled chest pain, or dangerous irregular heart rhythms
  • People who are pregnant or breastfeeding
  • People who have previously had an organ transplant and still require medication to suppress their immune system
  • People with other serious ongoing illnesses — including active infections, unstable heart conditions, or mental health or personal circumstances that could make it difficult to follow the trial requirements
  • People who have had a bad reaction or intolerance to CAR T-related medications or a substance called GM-CSF

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Jacalyn Rosenblatt, MD, Beth Israel Deaconess Medical Center

Phone: 617-667-9920

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
David Avigan
Registry
ClinicalTrials.gov
Start date
30 January 2026
Est. completion
1 March 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Treatment Limiting Toxicity (TLT) Rate; Vaccine/Granulocyte-Macrophage Colony-Stimulating Factor(GM-CSF)-Related Adverse Event (AE) Rate; Grade 3 or 4 Cytokine Release Syndrome (CRS) Rate; Grade 3 or 4 Immune-effector Cell-associated Neurotoxicity (ICANS) Rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov