Clinical trial · Interventional
Administration of TAA-Specific CTLs; Hodgkin or Non-Hodgkin Lymphoma; TACTAL
Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active or Relapsed Hodgkin or Non-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antigen-Escalation Stage | Biological | — | UNRESOLVED |
| azacytidine and multiTAA T cells Stage | Biological | — | UNRESOLVED |
| Dose-Escalation Stage | Biological | — | UNRESOLVED |
| Pediatric multiTAA T cells Stage | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Antigen-Escalation Stage
- description
- 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.
- interventionNames
- Biological: Antigen-Escalation Stage
- type
- EXPERIMENTAL
- label
- Dose-Escalation Study Stage
- description
- 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.
- interventionNames
- Biological: Dose-Escalation Stage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
PROCUREMENT:
1. Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma.
2. Life expectancy of 6 weeks or greater.
3. Hgb greater than or equal to 7.0
4. Patient and,or parent,guardian able to give informed consent.
TREATMENT:
1. 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
2. Life expectancy of 6 weeks or greater.
3. Pulse oximetry of more than 95 percent on room air in patients who previously received radiation therapy.
4. Karnofsky,Lansky score of 50 or greater.
5. Creatinine 2X or less of upper limit of normal for age.
6. Patients should have been off other investigational therapy for one month prior to entry in this study.
7. Patients should have been off conventional therapy for at least 1 week prior to entry in this study, including rituximab.
8. Patient and,or parent,guardian able to give informed consent.
9. 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.
10. 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:
11. Platelets greater than 25,000
Exclusion Criteria:
PROCUREMENT:
1. Patients with severe intercurrent infection.
2. Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).
3. Patients receiving systemic corticosteroids.
TREATMENT:
1. Patients with severe intercurrent infection.
2. Patients receiving systemic corticosteroids.
3. Pregnant breastfeeding.
4. 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:
5. Abnormal coagulation parameters (PT greater than 15 seconds, PTT greater than 40 seconds, and/or INR greater than 1.5)
6. Significant active cardiac disease within the previous 6 months including:
1. NYHA class 4 CHF
2. Unstable angina
3. Myocardial infarction
7. Known or suspected hypersensitivity to azacitidine or mannitol
8. Patients with advanced malignant hepatic tumors.References
Publications (1)
- DERIVEDVasileiou 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. PMID 33507803