Experimental T-Cell therapy takes aim at lymphoma
NCT ID NCT01333046
First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 4 times
Summary
This early-phase trial tests a new therapy for Hodgkin and non-Hodgkin lymphoma that has returned or not responded to standard treatment. Researchers take a patient's own immune cells, train them in the lab to recognize five cancer-specific proteins (tumor-associated antigens), and give them back as an infusion. Some adult patients also receive a drug called azacytidine to help the cells work better. The main goal is to see if this approach is safe and to learn how the immune system responds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes (CTLs), with or without azacytidine
- What this could lead to
- If successful, this could point toward a new treatment option for lymphoma patients who have not responded to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 36 participants, so it is primarily testing safety. The therapy may not shrink tumors or work for everyone, and there is a risk of side effects from the T cells or azacytidine.
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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36 people
The number who actually took part.
- Start date
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Jan 2012
- Finished
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Jul 2026
- 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.
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.
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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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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
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