Phase 2 Myeloma Trial, Recruiting NCT06066359 Sponsor: M.D. Anderson Cancer Center Condition: Myeloma
Back to Myeloma

Phase 2 Myeloma Trial, Recruiting

NCT06066359
Recruiting Phase 2

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:

  • You have been diagnosed with multiple myeloma, and a tumor sample has tested positive for a specific protein called NY-ESO-1
  • You have a specific genetic marker on your immune cells called HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06 (found through a blood test)
  • Your multiple myeloma has come back or stopped responding to treatment, and you have received at least 2 previous treatment regimens — including at least one from each of three specific drug types (a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody)
  • Your myeloma can still be measured through specific blood, urine, or protein tests, showing the disease is still active
  • You have not received any myeloma treatment within 7 days before the preparation treatment (called lymphodepletion) begins (steroids are still allowed up to that point)
  • You have had a previous stem cell transplant (your own or a donor's), which is allowed
  • You have had previous cell-based therapy, as long as it did not target the NY-ESO-1 protein
  • Your body has recovered from the side effects of your most recent myeloma treatment
  • You are generally able to carry out basic daily activities (a doctor will assess this using a standard scale)
  • Your kidneys are working at a reasonable level (confirm with trial site)
  • Your liver function test results are within acceptable ranges
  • Your bilirubin (a liver-related chemical) levels are within acceptable limits — slightly higher limits apply if you have a condition called Gilbert's syndrome
  • You do not have liver scarring (cirrhosis) or fluid buildup in the abdomen (ascites)
  • Your heart is pumping blood effectively (at least 50% efficiency on a scan)
  • You do not have significant fluid around your heart or lungs
  • You do not have uncontrolled heart rhythm problems or significant heart symptoms
  • Your blood oxygen level is above 92% while breathing normal air
  • You are between 18 and 80 years old
  • You weigh at least 40 kg (about 88 lbs)
  • Your blood counts (white cells, red cells, and platelets) meet minimum levels — with some flexibility if low counts are caused directly by the myeloma itself
  • You are able and willing to use effective birth control during the study and for at least 3 months after it ends
  • You are willing and able to sign a consent form and agree to long-term follow-up
  • You have relapsed or treatment-resistant plasma cell leukemia and have had at least two previous treatment regimens (confirm with trial site)

Who may not be able to join:

  • You have an active or uncontrolled infection at the time treatment is due to begin
  • You have an autoimmune disease that affects the nervous system, such as multiple sclerosis
  • You have received a live vaccine within the past 30 days
  • You are currently taking antibiotics for an active infection
  • You have had another type of cancer within the last 2 years that was not fully treated with the aim of curing it (some minor skin cancers or cervical conditions may still be acceptable — confirm with trial site)
  • You have had a major operation within 28 days, or a minor operation within 14 days, before the preparation treatment begins — or you have a planned procedure that the doctor believes could put you at risk

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 21 July 2026
Phase 2: approximately ~30% 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: Muzaffar Qazilbash, M D, M.D. Anderson Cancer Center

Phone: (713) 745-3458

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 2
Registry
ClinicalTrials.gov
Start date
30 November 2023
Est. completion
31 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of dose-limiting toxicities (Part A); Overall response rate (Part B)

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: 21 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