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Supercharged immune cells take aim at myeloma

NCT ID NCT02291848

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This early-stage trial tests whether specially trained immune cells can safely target and attack multiple myeloma, as well as its early forms MGUS and smoldering myeloma. Up to 36 participants will receive two infusions of their own T cells that have been engineered to recognize five proteins found on cancer cells. The main goal is to find the safest dose and watch for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAA-specific cytotoxic T-lymphocytes (immune cells)
What this could lead to
If it works, this could point toward a new way to control multiple myeloma or stop early forms from progressing.
What could go wrong
This is a very early Phase 1 trial with only 36 participants, so it may not work or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Apr 2015

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Procurement Inclusion Criteria * Any patient, at least 18 yrs old regardless of sex, with a diagnosis of high risk MGUS/smoldering myeloma or patients with a diagnosis of Multiple myeloma after receiving at least one treatment regimen OR * Any patient, ≥ 18 yrs old regardless of sex with a diagnosis of high risk MGUS (defined as have 2 of the following: 1. Non IgG MGUS, 2. M protein ≥ 1.5 g/dl, 3. Abnormal free light chain ratio (\<0.26 for lambda restricted disease or \>1.65 for kappa restricted disease) or a diagnosis of smoldering myeloma. * Patients with life expectancy greater than or equal to 6 weeks. * Hgb greater than or equal to 7.0 (transfusions allowed). * Patient able to give informed consent. Treatment Inclusion Criteria \- Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least one treatment regimen. If patient has received an autologous or syngeneic SCT they must be \>90 days post-transplant (Group A) OR Following autologous or syngeneic SCT (as adjuvant therapy) and \<90 days post transplant (Group B) OR Any patient ≥ 18 yrs old regardless of sex with a diagnosis of high risk MGUS/Smoldering myeloma (definition of high risk MGUS/smoldering myeloma provided in protocol) (Group C) * Patients with life expectancy greater than or equal to 6 weeks. * Pulse oximetry of \>93% on room air in patients who previously received radiation therapy. * Patients with a Karnofsky score of greater than or equal to 50. * Patients with bilirubin less than or equal to 2 times upper limit of normal, AST less than or equal to 3 times upper limit of normal, and Hgb greater than or equal to 7.0 (transfusion allowed). * Engrafted post transplant (ANC \>500) and ANC \>500 at the time of infusion if applicable. * Patients with a creatinine less than or equal to 2x upper limit of normal for age. * Patients should have been off other investigational therapy for one month prior to entry in this study. * Patients should have been off conventional therapy for at least 48 hours prior to entry in this study (except for lenalidomide, thalidomide, pomalidomide or immune checkpoint inhibitors such as CTLA4 and/or PD-1/PD-L1 inhibitors) * Patient able to give informed consent. * Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation. Procurement Exclusion Criteria * Patients with severe active infection. * Patients with active HIV infection at time of procurement (can be pending at the time of blood draw). Treatment Exclusion Criteria * Patients with severe active infection. * Patients receiving systemic corticosteroid within 48 hours of CTL infusion. * Pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Harris Health Ben Taub Hospital

    Houston, Texas, 77030, United States

  • Harris Health Smith Clinic

    Houston, Texas, 77030, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

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