Supercharged immune cells take aim at myeloma
NCT ID NCT02291848
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Apr 2015
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Harris Health Ben Taub Hospital
Houston, Texas, 77030, United States
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Harris Health Smith Clinic
Houston, Texas, 77030, United States
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Houston Methodist Hospital
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?