Supercharged immune cells take on Hard-to-Treat blood cancers
NCT ID NCT00881920
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new type of immune therapy for people with certain blood cancers (CLL, lymphoma, or multiple myeloma) that have come back or not responded to treatment. Researchers take a patient's own T cells, add a special receptor that targets a protein called kappa on cancer cells, and also add a growth booster (CD28) to help the cells last longer. The goal is to see if these modified cells are safe and can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Kappa-CD28 T cells (engineered immune cells)
- What this could lead to
- If successful, this could lead to a new treatment option for patients with certain blood cancers that have not responded to standard therapies.
- What could go wrong
- This is an early phase 1 trial with only 54 participants, so results may not apply to everyone. The cells may not last long in the body or could cause serious side effects.
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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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2009
- Expected to finish
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Jul 2035
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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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: BLOOD PROCUREMENT: * B-CLL or recurrent or refractory B-cell lymphoma (or other B-cell neoplasm) or multiple myeloma monoclonal for Kappa-light chain * Life expectancy of at least 12 weeks or greater. * No history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry * If requires pheresis to collect blood, Cre and AST less than 1.5 upper limit of normal * If requires pheresis to collect blood, PT and PTTK less than 1.5 upper limit normal T CELL TREATMENT: Diagnosis of: 1. B-CLL monoclonal for Kappa light chain with one of the following criteria: 1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia 2. Massive (ie, at least 6 cm below the left costal margin) or progressive or symptomatic splenomegaly 3. Massive nodes (ie, at least 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy 4. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months. 5. Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs: 1. Unintentional weight loss of 10% or more within the previous 6 months; 2. Significant fatigue (ie, ECOG PS 2 or worse; inability to work or perform usual activities); 3. Fevers higher than 100.5°F or 38.0°C for 2 or more weeks without other evidence of infection; or 4. Night sweats for more than 1 month without evidence of infection. 5. Patients who have resistant disease after primary treatment 6. Patients who have a short time to progression after the first treatment (less than 2 years) OR 2. Indolent or aggressive B-cell lymphoma (or other B-cell neoplasm) monoclonal for Kappa-light chain with measurable disease after receiving at least one chemotherapy regimen that includes Rituximab or an equivalent monoclonal antibody OR 3. Multiple myeloma monoclonal for Kappa-light chain with measurable disease after receiving at least one chemotherapy regimen * Life expectancy of at least 12 weeks or greater. * Recovered from the toxic effects of all prior chemotherapy before entering this study. PD1/PDL1 inhibitors will be allowed if medically indicated * ANC \> 500, Hgb greater than or equal to 7.0. * Bilirubin less than 3 times the upper limit of normal. * AST less than 5 times the upper limit of normal. * Estimated GFR \> 50mL/min * Pulse oximetry of \> 90% on room air * Karnofsky score of \> 60%. * Negative serology for HIV. * Available autologous transduced peripheral blood T-cells with 15% or more expression of CAR-Kappa determined by flow-cytometry. * Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients will be given a copy of the consent form. * Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom. * If patient has CLL, must have negative Coombs test. EXCLUSION CRITERIA: BLOOD PROCUREMENT: * Active infection requiring antibiotics * Active autoimmune disease T CELL TREATMENT: * Symptomatic cardiac disease. * History of hypersensitivity reactions to murine protein-containing products. Currently receiving any investigational agents within the previous six weeks or received any tumor vaccines within the previous 6 weeks. * Tumor in a location where enlargement could cause airway obstruction. * Pregnant or lactating.
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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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Chemotherapy plus immunotherapy tested against rare EBV-Driven immune storm
- Can a new drug combo improve myeloma treatment for older adults?
- Can a calming drug make cord blood transplants safer?
- Can a Nine-Week group program help blood cancer patients grow through trauma?
- Two-Drug combo aims to push CLL into deep remission