Supercharged immune cells take aim at cancer and viruses in one shot
NCT ID NCT00840853
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This study tests a new type of immune cell therapy for people with CD19-positive leukemia or lymphoma who have had a stem cell transplant. The cells are specially designed to both recognize and kill cancer cells (through a CD19-targeting antibody) and fight three common viruses (CMV, EBV, and adenovirus). The goal is to see if these cells can safely prevent relapse and infections, and how long they last in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gene-modified T cells that target CD19 and three common viruses (CMV, EBV, adenovirus)
- What this could lead to
- If successful, this approach could provide a long-lasting, dual-action therapy that prevents both viral infections and cancer relapse after stem cell transplant, potentially curing patients who would otherwise have few options.
- What could go wrong
- This is an early-phase trial focused on safety and dosing, so the treatment may not work as hoped. There is a risk of serious side effects, including graft-versus-host disease (GVHD) and other toxicities.
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
-
About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Apr 2009
- Expected to finish
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Apr 2031
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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
-
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: 1. Any patient regardless of sex or age with CD19+ B-ALL undergoing allogeneic HSCT (Group A) OR Any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B). AND With minimal residual disease (MRD) or relapse post-HSCT (for the phase I dose escalation) OR With no evidence of ALL or CLL/NHL post-HSCT (to be included in the expansion cohort 2. Patients with life expectancy greater than or equal to 6 weeks 3. Patients with a Karnofsky/Lansky score greater than or equal to 50 4. Donor HIV negative 5. Patient or parent/guardian capable of providing informed consent 6. Patients with bilirubin 2x normal or less, AST 3x normal or less, creatinine less than or equal to 2x normal for age and Hgb greater than 8.0 7. Pulse oximetry of greater than 90% on room air 8. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom. 9. Available allogeneic CD19CAR transduced tri-virus-specific cytotoxic T lymphocytes with greater than or equal to15% expression of CD19CAR determined by flow-cytometry and greater than 10% killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.\* 10. Patients should have been off other investigational antiviral or antitumor therapy for one month prior to entry in this study. * Note: Cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers. EXCLUSION CRITERIA: 1. Severe intercurrent infection 2. Evidence of graft versus host disease \>grade II 3. Pregnant or lactating 4. History of hypersensitivity reactions to murine protein-containing products. 5. Currently taking corticosteroids for therapy of GVHD.
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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
-
Houston Methodist Hospital
Houston, Texas, 77030, United States
-
Texas Children's Hospital
Houston, Texas, 77030, United States
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