Multiple MyelomaPhase 1TACTAMNCT02291848
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
A Phase 1 study testing TAA-specific CTLs and TAA-specific CTLs- fixed dose in people with Multiple Myeloma, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
This study is for patients that have a cancer called Multiple Myeloma, monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM). MGUS and SM have tumor cells that possess nearly identical properties to the cancer cells seen in patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- TAA-specific CTLs and TAA-specific CTLs- fixed dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2015to 22 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Harris Health Ben Taub Hospital
Houston, Texas, 77030
Harris Health Smith Clinic
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active Myeloma (TACTAM)
This study is for patients that have a cancer called Multiple Myeloma, monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM). MGUS and SM have tumor cells that possess nearly identical properties to the cancer cells seen in patients with multiple myeloma.
The investigators would like to target proteins that are expressed by these cells using the patient's own immune cells known as T lymphocytes.This research study uses special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes (CTLs), a new experimental therapy.
Read more
The proteins that investigators are targeting in this study are called tumor associated antigens (TAAs). These are cell proteins that are specific to the cancer cell.They either do not show or show up in low quantities on normal human cells. In this study the investigators are targeting five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different protocol, patients have been treated and so far this treatment has shown to be safe.
Investigators now want to try this treatment in patients with multiple myeloma or if the investigators can arrest the progression of the patient's condition condition (described above) to multiple myeloma.
These TAA-specific CTLs are an investigational product not approved by the Food and Drug Administration.
The purpose of this study is to find the largest safe dose of TAA-specific CTLs, to learn what the side effects are, and to see whether this therapy might help patients with multiple myeloma monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM)
.
Read the detailed description
Up to 390 mL (78 teaspoons) of blood will be collected from the patient on one to three occasions over a two month period. Under certain conditions related to the patient's health, the blood may need to be collected using a process called apheresis. Apheresis is the process where blood is passed through a machine that separates out the components of the blood that is needed. The remainder of the blood is then returned to the patient's body.
Investigators will use this blood to grow T cells. They will first grow a special type of cells called dendritic cells which will cause activity in the T cells. Once these are made the investigator will load them with small pieces of protein called peptides taken from the TAAs that they want to target. This helps to train the T cells to kill cells with TAAs on their surface. Then the investigators expand these TAA-specific CTLs.
The cells will be infused by intravenous (IV) infusion into the patient over 10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Initially, two doses of TAA-specific CTLs will be given two weeks apart. The patient's disease will be assessed pre-infusion and then 6 weeks after the second infusion. If after the second infusion there is a decrease in the patient's disease or it remains stable, the patient can receive up to six (6) additional doses of the TAA-specific CTLs at monthly intervals. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital.
In between the first and second infusions and for 6 weeks after the last infusion, the patient is asked not to receive any other anti-cancer treatments, such as radiation therapy or chemotherapy, with the exception of lenalidomide, thalidomide, pomalidomide, or immune checkpoint inhibitors, such as CTLA4 and/or PD-1/PD-L1 inhibitors. If they do receive any other therapies in-between the first and second infusion of cells, the patient will be taken off treatment and will not be able to receive the second infusion of cells. If the patient bad side effects from the first infusion, he or she will also not be able to receive the second infusion.
This is a dose escalation study. This means that at the beginning, patients will be started on the lowest dose (1 of 3 different levels) of TAA-specific CTLs. Once that dose schedule proves safe, the next group of patients will be started at a higher dose. This process will continue until all 3 dose levels are studied. If the side-effects are too severe, the dose will be lowered or the TAA-specific CTL infusions will be stopped.
For patients with monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM), they will receive a fixed dose of TAA-specific CTLs. This dose Was determined based on data obtained from patients who have multiple myeloma and have received these cells.
Medical Tests Before Treatment
Before being treated, the patient will receive a series of standard medical tests:
- Physical exam.
- Blood tests to measure blood cells, kidney and liver function.
- Measurement of the patient's multiple myeloma, MGUS or SM markers by blood tests and bone marrow biopsy (within 4 weeks before the CTL infusion)
- Measurements of the patient's tumor by routine imaging studies. The investigators will use the imaging study that was used before to follow the patient's tumor: Computerized Tomography (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET/CT), skeletal bone survey. These studies will be done on a case-by-case basis at the descretion of the patient's treating physician.
- Pregnancy test (using a blood sample) if the patient is a female who can have children.
Medical Tests After Treatment:
Patients will receive standard medical tests after their infusion:
- Blood tests to measure blood cells, kidney and liver function.
- Measurement of the patient's multiple myeloma, MGUS or SM markers by blood tests and bone marrow biopsy (at 4-6 weeks and 8-12 weeks post 1st CTL infusion).
- Measurements of your tumor by routine imaging studies. We will use the imaging study that was used before to follow your tumor: Computerized Tomography (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET/CT), skeletal bone survey. These studies will be done on a case-by-case basis at the discretion of your treating physician.
The investigators may request a sample of the patient's previous biopsy (e.g. bone marrow or other tissue) that he or she has had or from a biopsy performed at any time while they are on this study. The sample may be used to measure the multiple myeloma, MGUS or SM in the bone marrow, or for research purposes related to this study.
To learn more about the way the TAA-specific CTLs are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each infusion, and at Weeks 1, 2, 4 and 6. Afterwards, blood will be collected at 3, 6, 9 and 12 months after the last infusion. The investigators will use this blood to see how long the TAA-specific CTLs last, and to look at the immune response to the cancer. Patients will then be contacted once a year for up to 4 additional years (total of 5 years follow-up) to evaluate their disease response long-term.
- Conditions
- Multiple Myeloma
- Being tested
- TAA-specific CTLs, TAA-specific CTLs- fixed dose
- Keywords
- Multiple Myeloma, Cytotoxic T-lymphocytes
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAA-specific CTLsBiological
Groups A and B only: Each patient will receive 2 infusions at the same dose, 14 days apart, according to the following dosing schedules:
Dose Level One:
Day 0: 5 x 10^6 cells/m2 and Day 14: 5 x 10^6 cells/m2
Dose Level Two:
Day 0: 1 x 10^7 cells/m2 and Day 14: 1 x 10^7 cells/m2
Dose Level Three:
Day 0 2 x 10^7 cells/m2 and Day 14 2 x 10^7 cells/m2
If patients without measurable disease remain in complete remission or those patients with measurable active disease (for multiple myeloma, MGUS or smoldering myeloma) at the time of infusion have stable disease or a partial response at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number or less (if there is not enough product) than their second infusion.
TAA-specific CTLs- fixed doseBiological
Fixed dose of 2 infusions of 2 x 10^7 cells/m2 administered 2 weeks apart.
If patients without measurable disease remain in complete remission or those patients with measurable active disease (for multiple myeloma, MGUS or smoldering myeloma) at the time of infusion have stable disease or a partial response at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number or less (if there is not enough product) than their second infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients receiving TAA-specific CTLs as therapy for Myeloma Receives: Biological: TAA-specific CTLs |
| Group B | Experimental | Patients receiving TAA-Specific CTLs as adjunctive therapy following autologous or syngeneic transplant for myeloma Receives: Biological: TAA-specific CTLs |
| Group C | Experimental | Patients with high risk MGUS or smoldering myeloma receiving a fixed dose TAA-Specific CTLs Receives: Biological: TAA-specific CTLs- fixed dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Adverse events
To determine the safety of 2 intravenous injections of autologous TAA-specific cytotoxic T-lymphocytes (CTL) in patients with Myeloma as well as those with high risk MGUS/Smoldering myeloma.
Measured: 8 weeks
Secondary outcomes (3)
Expansion of the CTLs
Information on the expansion of the adoptively transferred tumor-specific CTL will be analyzed for the immunological parameters based on multimer analysis, intracellular cytokine staining and ELIspot assays to assess the frequency of cells secreting γ-IFN using the descriptive statistics such as mean, median, standard deviation at each time point.
Measured: 1 year
Persistence of the CTLs
Information on the persistence of the adoptively transferred tumor-specific CTL will be analyzed for the immunological parameters based on multimer analysis, intracellular cytokine staining and ELIspot assays to assess the frequency of cells secreting γ-IFN using the descriptive statistics such as mean, median, standard deviation at each time point.
Measured: 1 year
Reduction of the Multiple Myeloma
Comparison of diagnostic imaging studies from pre-infusion to 6 weeks following the second infusion will be summarized. Frequencies and proportions of responders will be summarized overall and by dose levels if there are enough patients per dose level.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2026 (estimated)
- Study completion22 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine, Harris County Hospital District
- Responsible party
- Principal investigator, Martha Mims, Baylor College of Medicine
- Investigators
- Martha Mims, MD, Principal investigator, Baylor College of MedicinePremal Lulla, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291848
- Sponsor's protocol ID
- H-35626, TACTAM
- Acronym
- TACTAM
- Status last verified
- Oct 2026
- First submitted
- 12 Nov 2014
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active Myeloma (TACTAM)
- ClinicalTrials.gov ID
- NCT02291848
- Acronym / sponsor ID
- TACTAM / H-35626, TACTAM
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Cytotoxic T-lymphocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine, Harris County Hospital District
- Study start
- Apr 2015
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 22 Dec 2027 (estimated)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for patients that have a cancer called Multiple Myeloma, monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM). MGUS and SM have tumor cells that possess nearly identical properties to the cancer cells seen in patients with multiple myeloma.
The investigators would like to target proteins that are expressed by these cells using the patient's own immune cells known as T lymphocytes.This research study uses special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes (CTLs), a new experimental therapy.
The proteins that investigators are targeting in this study are called tumor associated antigens (TAAs). These are cell proteins that are specific to the cancer cell.They either do not show or show up in low quantities on normal human cells. In this study the investigators are targeting five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different protocol, patients have been treated and so far this treatment has shown to be safe.
Investigators now want to try this treatment in patients with multiple myeloma or if the investigators can arrest the progression of the patient's condition condition (described above) to multiple myeloma.
These TAA-specific CTLs are an investigational product not approved by the Food and Drug Administration.
The purpose of this study is to find the largest safe dose of TAA-specific CTLs, to learn what the side effects are, and to see whether this therapy might help patients with multiple myeloma monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM)
.
Detailed description
Up to 390 mL (78 teaspoons) of blood will be collected from the patient on one to three occasions over a two month period. Under certain conditions related to the patient's health, the blood may need to be collected using a process called apheresis. Apheresis is the process where blood is passed through a machine that separates out the components of the blood that is needed. The remainder of the blood is then returned to the patient's body.
Investigators will use this blood to grow T cells. They will first grow a special type of cells called dendritic cells which will cause activity in the T cells. Once these are made the investigator will load them with small pieces of protein called peptides taken from the TAAs that they want to target. This helps to train the T cells to kill cells with TAAs on their surface. Then the investigators expand these TAA-specific CTLs.
The cells will be infused by intravenous (IV) infusion into the patient over 10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Initially, two doses of TAA-specific CTLs will be given two weeks apart. The patient's disease will be assessed pre-infusion and then 6 weeks after the second infusion. If after the second infusion there is a decrease in the patient's disease or it remains stable, the patient can receive up to six (6) additional doses of the TAA-specific CTLs at monthly intervals. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital.
In between the first and second infusions and for 6 weeks after the last infusion, the patient is asked not to receive any other anti-cancer treatments, such as radiation therapy or chemotherapy, with the exception of lenalidomide, thalidomide, pomalidomide, or immune checkpoint inhibitors, such as CTLA4 and/or PD-1/PD-L1 inhibitors. If they do receive any other therapies in-between the first and second infusion of cells, the patient will be taken off treatment and will not be able to receive the second infusion of cells. If the patient bad side effects from the first infusion, he or she will also not be able to receive the second infusion.
This is a dose escalation study. This means that at the beginning, patients will be started on the lowest dose (1 of 3 different levels) of TAA-specific CTLs. Once that dose schedule proves safe, the next group of patients will be started at a higher dose. This process will continue until all 3 dose levels are studied. If the side-effects are too severe, the dose will be lowered or the TAA-specific CTL infusions will be stopped.
For patients with monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM), they will receive a fixed dose of TAA-specific CTLs. This dose Was determined based on data obtained from patients who have multiple myeloma and have received these cells.
Medical Tests Before Treatment
Before being treated, the patient will receive a series of standard medical tests:
- Physical exam.
- Blood tests to measure blood cells, kidney and liver function.
- Measurement of the patient's multiple myeloma, MGUS or SM markers by blood tests and bone marrow biopsy (within 4 weeks before the CTL infusion)
- Measurements of the patient's tumor by routine imaging studies. The investigators will use the imaging study that was used before to follow the patient's tumor: Computerized Tomography (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET/CT), skeletal bone survey. These studies will be done on a case-by-case basis at the descretion of the patient's treating physician.
- Pregnancy test (using a blood sample) if the patient is a female who can have children.
Medical Tests After Treatment:
Patients will receive standard medical tests after their infusion:
- Blood tests to measure blood cells, kidney and liver function.
- Measurement of the patient's multiple myeloma, MGUS or SM markers by blood tests and bone marrow biopsy (at 4-6 weeks and 8-12 weeks post 1st CTL infusion).
- Measurements of your tumor by routine imaging studies. We will use the imaging study that was used before to follow your tumor: Computerized Tomography (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET/CT), skeletal bone survey. These studies will be done on a case-by-case basis at the discretion of your treating physician.
The investigators may request a sample of the patient's previous biopsy (e.g. bone marrow or other tissue) that he or she has had or from a biopsy performed at any time while they are on this study. The sample may be used to measure the multiple myeloma, MGUS or SM in the bone marrow, or for research purposes related to this study.
To learn more about the way the TAA-specific CTLs are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each infusion, and at Weeks 1, 2, 4 and 6. Afterwards, blood will be collected at 3, 6, 9 and 12 months after the last infusion. The investigators will use this blood to see how long the TAA-specific CTLs last, and to look at the immune response to the cancer. Patients will then be contacted once a year for up to 4 additional years (total of 5 years follow-up) to evaluate their disease response long-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: TAA-specific CTLsPatients receiving TAA-specific CTLs as therapy for Myeloma |
| Group B | Experimental | Biological: TAA-specific CTLsPatients receiving TAA-Specific CTLs as adjunctive therapy following autologous or syngeneic transplant for myeloma |
| Group C | Experimental | Biological: TAA-specific CTLs- fixed dosePatients with high risk MGUS or smoldering myeloma receiving a fixed dose TAA-Specific CTLs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAA-specific CTLsGroups A and B only: Each patient will receive 2 infusions at the same dose, 14 days apart, according to the following dosing schedules: Dose Level One: Day 0: 5 x 10^6 cells/m2 and Day 14: 5 x 10^6 cells/m2 Dose Level Two: Day 0: 1 x 10^7 cells/m2 and Day 14: 1 x 10^7 cells/m2 Dose Level Three: Day 0 2 x 10^7 cells/m2 and Day 14 2 x 10^7 cells/m2 If patients without measurable disease remain in complete remission or those patients with measurable active disease (for multiple myeloma, MGUS or smoldering myeloma) at the time of infusion have stable disease or a partial response at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number or less (if there is not enough product) than their second infusion. | Biological | Group A, Group B |
| TAA-specific CTLs- fixed doseFixed dose of 2 infusions of 2 x 10^7 cells/m2 administered 2 weeks apart. If patients without measurable disease remain in complete remission or those patients with measurable active disease (for multiple myeloma, MGUS or smoldering myeloma) at the time of infusion have stable disease or a partial response at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number or less (if there is not enough product) than their second infusion. | Biological | Group C |
Primary outcome
Number of Patients with Adverse events
Time frame: 8 weeks
To determine the safety of 2 intravenous injections of autologous TAA-specific cytotoxic T-lymphocytes (CTL) in patients with Myeloma as well as those with high risk MGUS/Smoldering myeloma.
3 secondary outcomes
Expansion of the CTLs
Time frame: 1 year
Persistence of the CTLs
Time frame: 1 year
Reduction of the Multiple Myeloma
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Mims, MD principal investigator
Baylor College of Medicine
Premal Lulla, MD principal investigator
The Methodist Hospital Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAA-specific CTLs and TAA-specific CTLs- fixed dose in people with Multiple Myeloma, run by Baylor College of Medicine at 3 sites 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?
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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Patients with Adverse events (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.