Hodgkin LymphomaPhase 1TACTALNCT01333046
Administration of TAA-Specific CTLs; Hodgkin or Non-Hodgkin Lymphoma; TACTAL
A Phase 1 study testing Antigen-Escalation Stage, Dose-Escalation Stage and azacytidine and multiTAA T cells Stage in people with Hodgkin Lymphoma and Non-Hodgkin Lymphoma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has come back, or may come back, or has not gone away after treatment, including the standard treatment known for these diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Disease
- What is being tested?
- Antigen-Escalation Stage, Dose-Escalation Stage and azacytidine and multiTAA T cells Stage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- PROCUREMENT:
- Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma.
- Life expectancy of 6 weeks or greater.
- Hgb greater than or equal to 7.0
- Patient and,or parent,guardian able to give informed consent.
- TREATMENT:
Show all 44Show fewer
- Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma:
- Group A: Patients greater than or equal to 18 years old
- with active disease:
- in second or subsequent relapse.
- in first relapse for indolent lymphoma after first-line therapy for relapse.
- or first relapse if immunosuppressive chemotherapy contraindicated.
- primary refractory disease or if persistent disease after first-line therapy of relapse.
- or multiply relapsed patients in remission who are at a high risk of relapse.
- or the lymphoma is a second malignancy e.g. a Richters transformation of CLL after failing front line therapy.
- OR
- Group B: Patients greater than or equal to 18 years old after autologous or syngeneic SCT (as adjuvant therapy).
- OR
- Group C: azacytidine plus multiTAA-T cells Patients greater than or equal to 18 years old
- with active disease in:
- second or subsequent relapse
- first relapse for indolent lymphoma after first line therapy for relapse
- first relapse if immunosuppressive chemotherapy contraindicated
- with primary refractory disease or persistent disease after first line therapy of relapse
- or lymphoma as a second malignancy e.g. a Richters transformation of CLL after failing front line therapy
- OR
- GROUP D: Patients less than 18 yrs old
- with active disease in:
- second or subsequent relapse
- first relapse for indolent lymphoma after first line therapy for relapse
- first relapse if immunosuppressive chemotherapy contraindicated
- with primary refractory disease or persistent disease after first line therapy of relapse
- with lymphoma as a second malignancy e.g. a Richters transformation of CLL after failing front line therapy
- Life expectancy of 6 weeks or greater.
- Pulse oximetry of more than 95 percent on room air in patients who previously received radiation therapy.
- Karnofsky,Lansky score of 50 or greater.
- Creatinine 2X or less of 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 1 week prior to entry in this study, including rituximab.
- Patient and,or parent,guardian 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 should use of at least two forms of contraception unless female has had a hysterectomy or tubal ligation.
- Bilirubin 2X or less of upper limit of normal, AST 3X or less than the upper limit of normal, and Hgb greater than or equal to 7.0
- GROUP C (aza) Only:
- Platelets greater than 25,000
Who cannot join
- PROCUREMENT:
- Patients with severe intercurrent infection.
- Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).
- Patients receiving systemic corticosteroids.
- TREATMENT:
- Patients with severe intercurrent infection.
Show all 17Show fewer
- Patients receiving systemic corticosteroids.
- Pregnant breastfeeding.
- Active viral infection with HIV or hepatitis type B or C. "Active" infection defined as infectious disease testing indicating that patient blood is reactive for Hep B, C and/or HIV and confirmed using PCR to measure viral load.
- GROUP C (aza) Only:
- Abnormal coagulation parameters (PT greater than 15 seconds, PTT greater than 40 seconds, and/or INR greater than 1.5)
- Significant active cardiac disease within the previous 6 months including:
- NYHA class 4 CHF
- Unstable angina
- Myocardial infarction
- Known or suspected hypersensitivity to azacitidine or mannitol
- Patients with advanced malignant hepatic tumors.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active or Relapsed Hodgkin or Non-Hodgkin Lymphoma
Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has come back, or may come back, or has not gone away after treatment, including the standard treatment known for these diseases. This a research study using special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.
This sort of therapy has been used previously to treat Hodgkin or non-Hodgkin lymphomas that show proof of infection with Epstein-Barr virus (EBV), the virus that causes infectious mononucleosis ("mono" or the "kissing disease"). EBV is found in cancer cells of up to half of all patients with Hodgkin's and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed. Investigators tested whether special white blood cells, called T cells, that were trained to kill EBV-infected cells could affect these tumors, and in many patients it was found that giving these trained T cells caused a complete or partial response.
Read more
However, many patients do not have EBV in their lymphoma cells; therefore investigators now want to test whether it is possible to direct these special T cells against other types of proteins on the tumor cell surface with similar promising results. The proteins that will be targeted in this study are called tumor associated antigens (TAAs) - these are cell proteins that are specific to the cancer cell, so they either do not show or show up in low quantities on normal human cells.
In this study, we will target five TAAs which commonly show on lymphoma, called: NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. This will be done by using special types of T cells called cytotoxic T lymphocytes (CTLs) generated in the lab.
In addition, some adult patients will receive a drug called azacytidine before giving the T cells. We hope that the combination helps the T cells work better.
Read the detailed description
The patient will give blood to make TAA-specific cytotoxic T cells in the lab. These cells will be grown and frozen. If the TAA-specific cytotoxic T cells can be made, the time from collection of the blood to manufacture of T cells for administration to the patient is about 1 to 2 months.
There are 4 stages of this study: an antigen-escalation phase, a dose-escalation stage, aza stage and pediatric patients stage.
The antigen-escalation phase will be first. Patients will receive TAA-specific T cells targeting first 1 and then 2 TAAs. Once this schedule proves safe, the next group of patients will receive TAA-specific T cells targeting first 2 and then 3 TAAs. This process will continue until all 4 levels are studied. This means that the final cohort of patients will receive TAA-specific T cells targeting first 4 and then 5 TAAs. If the side-effects are too severe, the number of TAAs being targeted will be lowered or the T cell injections will be stopped. Each patient will receive 2 infusions at the same dose 28 days apart
After the antigen-escalation phase, the dose-escalation phase will begin. Patients will be started on the lowest dose (1 of 3 different levels) of T cells. 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 T cell injections will be stopped. Each patient will receive 2 infusions at the same dose 14 days apart
After the dose escalation stage, adult patients will be enrolled on the aza stage where they will receive the drug aza followed by two infusions of T cells on dose level 2. Patients will be given 3 cycles of aza (administered daily through a vein for 5 days, every 28 days) followed by 2 doses of multiTAA-specific T cells administered 14 days apart. Before the patient is given the aza they will be given a drug to help prevent nausea and vomiting.
On the pediatric stage, pediatric patients will receive 2 infusions of T cells on dose level 2. The T cells will be given 14 days apart.
The cells will be injected by IV over 10 minutes. The patients may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the T cell administration. If after the second infusion there is a reduction in the size of the patient's lymphoma on CT or MRI scan as assessed by a radiologist, the patient can receive up to six (6) additional doses of the T cells at monthly intervals if they wish. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital or Texas Children's Hospital.
In between the first and second T cell infusions and for 6 weeks after the last infusion, the patient should not receive any other anti-cancer treatments such as radiation therapy or chemotherapy. If the patient does receive any other therapies in-between the first and second infusion of T cells, they will be taken off treatment and will not be able to receive the second infusion of T cells.
MEDICAL TESTS BEFORE TREATMENT
- Physical exam.
- Blood tests to measure blood cells, kidney and liver function.
- Measurements of your tumor by routine imaging studies. We will use the imaging study that was used before to follow your tumor: CT, MRI, or PET.
- Pregnancy test if you are a female who can have children.
MEDICAL TESTS AFTER TREATMENT
- Imaging study 6 weeks after the 2nd TAA-CTL infusion.
To learn more about the way the T cells are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each cycle of aza (if applicable), 2 weeks after each cycle of aza (if applicable), before each T-cell infusion, and at Weeks 1, 2, 4 and 6. One additional blood sample might be drawn 3 to 4 days post the T-cell infusion; this is optional. Afterwards, blood will be collected at 3, 6, 9 and 12 months after the last infusion. The blood may be drawn from a central line at the time of the patient's regular blood tests. Investigators will use this blood to see how long the T cells last,and to look at the immune response to the patient's cancer.
Study Duration: Patients will be on active study participation for approximately one year. Patients who receive additional doses of the T cells as described above will be actively followed until 1 year after their last dose of T cells. Investigators will then remain in contact with patients once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate disease response long-term.
- Conditions
- Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Disease
- Being tested
- Antigen-Escalation Stage, Dose-Escalation Stage, azacytidine and multiTAA T cells Stage, Pediatric multiTAA T cells Stage
- Keywords
- Hodgkin Lymphoma, Non-Hodgkin Lymphoma, CTL
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigen-Escalation StageBiological
Also called T cell injection, Tumor-specific CTL lines
Antigen-Escalation Stage
Each patient will receive 2 injections at the same dose (5 x 10^6 cells/m2), 28 days apart, according to the following schedules:
Schedule One:
- Day 0: PRAME-specific T cells
- Day 28: PRAME- and SSX-specific T cells
Schedule Two:
- Day 0: PRAME- and SSX-specific T cells
- Day 28: PRAME/SSX/MAGE-specific T cells
Schedule Three:
- Day 0: PRAME/SSX/MAGE-specific T cells
- Day 28: PRAME/SSX/MAGE/NY-ESO specific T cells
Schedule Four:
- Day 0: PRAME/SSX/MAGE/NY-ESO specific T cells
- Day 28: PRAME/SSX/MAGE/NY-ESO/Survivin-specific T cells
Dose-Escalation StageBiological
Also called TAA-CTL infusion
Dose-Escalation Stage
Three different dosing schedules will be evaluated. Each patient will receive 2 injections at the same dose, 14 days apart, according to the following dosing schedules:
DL1: Day 0 and Day 14: 5 x 10^6 cells/m^2
DL2: Day 0 and Day 14: 1 x 10^7 cells/m^2
DL3: Day 0 and Day 14: 2 x 10^7 cells/m^2
azacytidine and multiTAA T cells StageBiological
Up to 15 patients will be treated with 3 cycles of aza at a dose of 75 mg/m2 I.V. administered for 5 days/cycle followed, within 28 days of the last aza dose, by two infusions (on Day 0 and Day 14) of multi-TAA specific CTLs at a fixed dose of 1x10^7 cells/m2. If drug-related myelosuppression occurs aza dosing will be modified, according to the following:
- ANC >1,000 or Platelets >50,000 (or any other grade I AE attributable to aza) Adjustment: None
- ANC 500-1000 or Platelets 25,000-50,000 (or any other grade II-III AE attributable to aza) Adjustment: 50% dose reduction
- ANC <500 or any episode of febrile neutropenia or platelets <25,000 or any episode of bleeding attributed to thrombocytopenia (or any other grade IV or higher AE attributable to aza)
Adjustment: Discontinue drug, can proceed with CTL infusion if eligible within 28 days of last aza infusion
Pediatric multiTAA T cells StageBiological
Patients < 18 years old will receive two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10^7 cells/m2. We will enroll and infuse at least 5 adolescents on the pediatric arm before opening to all patients.
| Study group | Role | What they receive |
|---|---|---|
| Antigen-Escalation Stage | Experimental | The first stage will be an "antigen-escalation" stage using a fixed total dose of cells (5 x 10^6 cells/m^2 x 2) to evaluate the safety of the T cells primed against PRAME pepmix, and then SSX pepmix, and then MAGE A4 pepmix, and then NY-ESO pepmix, and then SURVIVIN pepmix. Receives: Biological: Antigen-Escalation Stage |
| Dose-Escalation Study Stage | Experimental | In the dose escalation stage, three dose levels will be studied. Patients in the dose escalation portion of the study will be entered and stratified separately to the following two groups:
Group A: Patients receiving CTLs as therapy for Hodgkin's or non-Hodgkin's lymphoma.
Group B: Patients receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. Receives: Biological: Dose-Escalation Stage |
| azacytidine and multiTAA T cells Stage | Experimental | This phase will administer aza intravenously at a dose of 75 mg/m2 after premedication with an anti-emetic such as ondansetron po or IV (up to a maximum dose of 16 mg ondansetron or equivalent). This phase will determine whether infusion of TAA-specific T cells (at dose level 2 - 1x10^7) targeting multiple tumor antigens in combination with azacytidine is safe, and whether CTL infusions (with or without azacytidine) increase the spectrum of epitopes/antigens targeted by endogenous T cells (epitope spreading). Receives: Biological: azacytidine and multiTAA T cells Stage |
| Pediatric multiTAA T cells Stage | Experimental | This phase will give patients < 18 years old two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10^7 cells/m2. This phase will test the safety and efficacy of multiTAA-specific T cells in pediatric patients with active HL/NHL. Receives: Biological: Pediatric multiTAA T cells Stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of patients with adverse events
To determine the safety of 2 intravenous injections of autologous TAA-specific cytotoxic T lymphocytes (CTLs) in patients with Hodgkin or non-Hodgkin lymphoma.
Measured: 8 weeks
Number of Patients with treatment related Serious Adverse Events
To determine whether infusion of TAA-specific T cells targeting multiple tumor antigens in combination with azacytidine is safe
Measured: 8 weeks
Secondary outcomes (2)
Obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTLs
Information on the expansion, persistence and anti-tumor effects of the adoptively transferred tumor-specific CTLs 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 timepoint.
Measured: 1 year
Assessment of increasing the spectrum of epitopes/antigens
To determine whether CTL infusions increase the spectrum of epitopes/antigens targeted by endogenous T cells (epitope spreading).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startJan 2012
- Primary completion27 Sep 2021
- Study completionJul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, George Carrum, Baylor College of Medicine
- Investigators
- Geoge Carrum, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333046
- Sponsor's protocol ID
- H-27471-TACTAL
- Other IDs
- TACTAL, 2P50CA126752-11
- Acronym
- TACTAL
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2011
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vasileiou S, Lulla PD, Tzannou I, Watanabe A, Kuvalekar M, Callejas WL, Bilgi M, Wang T, Wu MJ, Kamble R, Ramos CA, Rouce RH, Zeng Z, Gee AP, Grilley BJ, Vera JF, Bollard CM, Brenner MK, Heslop HE, Rooney CM, Leen AM, Carrum G. T-Cell Therapy for Lymphoma Using Nonengineered Multiantigen-Targeted T Cells Is Safe and Produces Durable Clinical Effects. J Clin Oncol. 2021 May 1;39(13):1415-1425. doi: 10.1200/JCO.20.02224. Epub 2021 Jan 28.
PubMed 33507803
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 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 or Relapsed Hodgkin or Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT01333046
- Acronym / sponsor ID
- TACTAL / H-27471-TACTAL
- Conditions
- Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Disease
- Keywords
- Hodgkin Lymphoma, Non-Hodgkin Lymphoma, CTL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute, National Cancer Institute (NCI)
- Study start
- Jan 2012
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- Jul 2026 (actual)
- First posted
- 11 Apr 2011 (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.
Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has come back, or may come back, or has not gone away after treatment, including the standard treatment known for these diseases. This a research study using special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.
This sort of therapy has been used previously to treat Hodgkin or non-Hodgkin lymphomas that show proof of infection with Epstein-Barr virus (EBV), the virus that causes infectious mononucleosis ("mono" or the "kissing disease"). EBV is found in cancer cells of up to half of all patients with Hodgkin's and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed. Investigators tested whether special white blood cells, called T cells, that were trained to kill EBV-infected cells could affect these tumors, and in many patients it was found that giving these trained T cells caused a complete or partial response.
However, many patients do not have EBV in their lymphoma cells; therefore investigators now want to test whether it is possible to direct these special T cells against other types of proteins on the tumor cell surface with similar promising results. The proteins that will be targeted in this study are called tumor associated antigens (TAAs) - these are cell proteins that are specific to the cancer cell, so they either do not show or show up in low quantities on normal human cells.
In this study, we will target five TAAs which commonly show on lymphoma, called: NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. This will be done by using special types of T cells called cytotoxic T lymphocytes (CTLs) generated in the lab.
In addition, some adult patients will receive a drug called azacytidine before giving the T cells. We hope that the combination helps the T cells work better.
Detailed description
The patient will give blood to make TAA-specific cytotoxic T cells in the lab. These cells will be grown and frozen. If the TAA-specific cytotoxic T cells can be made, the time from collection of the blood to manufacture of T cells for administration to the patient is about 1 to 2 months.
There are 4 stages of this study: an antigen-escalation phase, a dose-escalation stage, aza stage and pediatric patients stage.
The antigen-escalation phase will be first. Patients will receive TAA-specific T cells targeting first 1 and then 2 TAAs. Once this schedule proves safe, the next group of patients will receive TAA-specific T cells targeting first 2 and then 3 TAAs. This process will continue until all 4 levels are studied. This means that the final cohort of patients will receive TAA-specific T cells targeting first 4 and then 5 TAAs. If the side-effects are too severe, the number of TAAs being targeted will be lowered or the T cell injections will be stopped. Each patient will receive 2 infusions at the same dose 28 days apart
After the antigen-escalation phase, the dose-escalation phase will begin. Patients will be started on the lowest dose (1 of 3 different levels) of T cells. 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 T cell injections will be stopped. Each patient will receive 2 infusions at the same dose 14 days apart
After the dose escalation stage, adult patients will be enrolled on the aza stage where they will receive the drug aza followed by two infusions of T cells on dose level 2. Patients will be given 3 cycles of aza (administered daily through a vein for 5 days, every 28 days) followed by 2 doses of multiTAA-specific T cells administered 14 days apart. Before the patient is given the aza they will be given a drug to help prevent nausea and vomiting.
On the pediatric stage, pediatric patients will receive 2 infusions of T cells on dose level 2. The T cells will be given 14 days apart.
The cells will be injected by IV over 10 minutes. The patients may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the T cell administration. If after the second infusion there is a reduction in the size of the patient's lymphoma on CT or MRI scan as assessed by a radiologist, the patient can receive up to six (6) additional doses of the T cells at monthly intervals if they wish. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital or Texas Children's Hospital.
In between the first and second T cell infusions and for 6 weeks after the last infusion, the patient should not receive any other anti-cancer treatments such as radiation therapy or chemotherapy. If the patient does receive any other therapies in-between the first and second infusion of T cells, they will be taken off treatment and will not be able to receive the second infusion of T cells.
MEDICAL TESTS BEFORE TREATMENT
- Physical exam.
- Blood tests to measure blood cells, kidney and liver function.
- Measurements of your tumor by routine imaging studies. We will use the imaging study that was used before to follow your tumor: CT, MRI, or PET.
- Pregnancy test if you are a female who can have children.
MEDICAL TESTS AFTER TREATMENT
- Imaging study 6 weeks after the 2nd TAA-CTL infusion.
To learn more about the way the T cells are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each cycle of aza (if applicable), 2 weeks after each cycle of aza (if applicable), before each T-cell infusion, and at Weeks 1, 2, 4 and 6. One additional blood sample might be drawn 3 to 4 days post the T-cell infusion; this is optional. Afterwards, blood will be collected at 3, 6, 9 and 12 months after the last infusion. The blood may be drawn from a central line at the time of the patient's regular blood tests. Investigators will use this blood to see how long the T cells last,and to look at the immune response to the patient's cancer.
Study Duration: Patients will be on active study participation for approximately one year. Patients who receive additional doses of the T cells as described above will be actively followed until 1 year after their last dose of T cells. Investigators will then remain in contact with patients once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate disease response long-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Antigen-Escalation Stage | Experimental | Biological: Antigen-Escalation StageThe first stage will be an "antigen-escalation" stage using a fixed total dose of cells (5 x 10^6 cells/m^2 x 2) to evaluate the safety of the T cells primed against PRAME pepmix, and then SSX pepmix, and then MAGE A4 pepmix, and then NY-ESO pepmix, and then SURVIVIN pepmix. |
| Dose-Escalation Study Stage | Experimental | Biological: Dose-Escalation StageIn the dose escalation stage, three dose levels will be studied. Patients in the dose escalation portion of the study will be entered and stratified separately to the following two groups: Group A: Patients receiving CTLs as therapy for Hodgkin's or non-Hodgkin's lymphoma. Group B: Patients receiving CTLs as adjunctive therapy following autologous or syngeneic transplant. |
| azacytidine and multiTAA T cells Stage | Experimental | Biological: azacytidine and multiTAA T cells StageThis phase will administer aza intravenously at a dose of 75 mg/m2 after premedication with an anti-emetic such as ondansetron po or IV (up to a maximum dose of 16 mg ondansetron or equivalent). This phase will determine whether infusion of TAA-specific T cells (at dose level 2 - 1x10^7) targeting multiple tumor antigens in combination with azacytidine is safe, and whether CTL infusions (with or without azacytidine) increase the spectrum of epitopes/antigens targeted by endogenous T cells (epitope spreading). |
| Pediatric multiTAA T cells Stage | Experimental | Biological: Pediatric multiTAA T cells StageThis phase will give patients < 18 years old two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10^7 cells/m2. This phase will test the safety and efficacy of multiTAA-specific T cells in pediatric patients with active HL/NHL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (44 listed)
- Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma.
- Life expectancy of 6 weeks or greater.
- Hgb greater than or equal to 7.0
- Patient and,or parent,guardian able to give informed consent.
- Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma:
Key exclusion criteria (17 listed)
- Patients with severe intercurrent infection.
- Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).
- Patients receiving systemic corticosteroids.
- Patients with severe intercurrent infection.
- Patients receiving systemic corticosteroids.
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 |
|---|---|---|
| Antigen-Escalation StageAlso: T cell injection, Tumor-specific CTL linesAntigen-Escalation Stage Each patient will receive 2 injections at the same dose (5 x 10^6 cells/m2), 28 days apart, according to the following schedules: Schedule One: * Day 0: PRAME-specific T cells * Day 28: PRAME- and SSX-specific T cells Schedule Two: * Day 0: PRAME- and SSX-specific T cells * Day 28: PRAME/SSX/MAGE-specific T cells Schedule Three: * Day 0: PRAME/SSX/MAGE-specific T cells * Day 28: PRAME/SSX/MAGE/NY-ESO specific T cells Schedule Four: * Day 0: PRAME/SSX/MAGE/NY-ESO specific T cells * Day 28: PRAME/SSX/MAGE/NY-ESO/Survivin-specific T cells | Biological | Antigen-Escalation Stage |
| Dose-Escalation StageAlso: TAA-CTL infusionDose-Escalation Stage Three different dosing schedules will be evaluated. Each patient will receive 2 injections at the same dose, 14 days apart, according to the following dosing schedules: DL1: Day 0 and Day 14: 5 x 10^6 cells/m^2 DL2: Day 0 and Day 14: 1 x 10^7 cells/m^2 DL3: Day 0 and Day 14: 2 x 10^7 cells/m^2 | Biological | Dose-Escalation Study Stage |
| azacytidine and multiTAA T cells StageUp to 15 patients will be treated with 3 cycles of aza at a dose of 75 mg/m2 I.V. administered for 5 days/cycle followed, within 28 days of the last aza dose, by two infusions (on Day 0 and Day 14) of multi-TAA specific CTLs at a fixed dose of 1x10^7 cells/m2. If drug-related myelosuppression occurs aza dosing will be modified, according to the following: 1. ANC >1,000 or Platelets >50,000 (or any other grade I AE attributable to aza) Adjustment: None 2. ANC 500-1000 or Platelets 25,000-50,000 (or any other grade II-III AE attributable to aza) Adjustment: 50% dose reduction 3. ANC <500 or any episode of febrile neutropenia or platelets <25,000 or any episode of bleeding attributed to thrombocytopenia (or any other grade IV or higher AE attributable to aza) Adjustment: Discontinue drug, can proceed with CTL infusion if eligible within 28 days of last aza infusion | Biological | azacytidine and multiTAA T cells Stage |
| Pediatric multiTAA T cells StagePatients < 18 years old will receive two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10^7 cells/m2. We will enroll and infuse at least 5 adolescents on the pediatric arm before opening to all patients. | Biological | Pediatric multiTAA T cells Stage |
Primary outcome
Assessment of patients with adverse events
Time frame: 8 weeks
To determine the safety of 2 intravenous injections of autologous TAA-specific cytotoxic T lymphocytes (CTLs) in patients with Hodgkin or non-Hodgkin lymphoma.
Number of Patients with treatment related Serious Adverse Events
Time frame: 8 weeks
To determine whether infusion of TAA-specific T cells targeting multiple tumor antigens in combination with azacytidine is safe
2 secondary outcomes
Obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTLs
Time frame: 1 year
Assessment of increasing the spectrum of epitopes/antigens
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Derived from this study: PubMed 33507803Vasileiou S, Lulla PD, Tzannou I, Watanabe A, Kuvalekar M, Callejas WL, Bilgi M, Wang T, Wu MJ, Kamble R, Ramos CA, Rouce RH, Zeng Z, Gee AP, Grilley BJ, Vera JF, Bollard CM, Brenner MK, Heslop HE, Rooney CM, Leen AM, Carrum G. T-Cell Therapy for Lymphoma Using Nonengineered Multiantigen-Targeted T Cells Is Safe and Produces Durable Clinical Effects. J Clin Oncol. 2021 May 1;39(13):1415-1425. doi: 10.1200/JCO.20.02224. Epub 2021 Jan 28.
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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.
Geoge Carrum, MD principal investigator
Baylor College of Medicine
2 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 Antigen-Escalation Stage, Dose-Escalation Stage and azacytidine and multiTAA T cells Stage in people with Hodgkin Lymphoma and Non-Hodgkin Lymphoma, run by Baylor College of Medicine at 2 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?
The sponsor lists 44 inclusion and 17 exclusion criteria. 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: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of patients with adverse events (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01333046, which also lists 1 linked publication.
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 1 Sep 2026.