Engineered immune cells take aim at Tough-to-Treat blood cancers
NCT ID NCT04007029
First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This early-phase trial is testing a new type of CAR-T cell therapy that targets two proteins (CD19 and CD20) on cancer cells. It is for people with certain B-cell lymphomas or chronic lymphocytic leukemia that have come back or not responded to standard treatments. The therapy involves modifying a patient's own immune cells to better recognize and attack the cancer, combined with chemotherapy. The main goals are to check safety and find the best dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD19/CD20 bispecific CAR-T cells
- What this could lead to
- If successful, this could offer a new treatment option for patients with hard-to-treat B-cell cancers that have not responded to standard therapies.
- What could go wrong
- This is a very early (phase 1) trial with only 24 participants, so it is primarily testing safety and dosing. The treatment may not work for everyone, and side effects like cytokine release syndrome are possible.
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 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2019
- Expected to finish
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Aug 2028
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 to 70 years
- 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: * Diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL) that is refractory to standard-of-care options * DLBCL and PMBCL: primary refractory; relapsed after two prior lines of therapy * MCL, FL, CLL, and SLL: primary refractory; relapsed after three or more prior rounds of therapy * \> 30% positivity in malignant cells of either CD19 and/or CD20 * Minimum tumor burden of 1.5 cm\^3 for lymphoma * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate bone marrow and major organ function to undergo a T cell transplant determined within 30?60 days prior to enrollment using standard phase I criteria for organ function. Blood may be evaluated while a patient is receiving growth factor support. Patients will be re-evaluated for organ function within 14 days of beginning conditioning chemotherapy * Absolute neutrophil count (ANC) \>= 1 x 10\^9 cells/L (within 30-60 days prior to enrollment) * Platelets \>= 75 x 10\^9/L (within 30-60 days prior to enrollment) * Hemoglobin \>= 8 g/dL (with or without transfusion) (within 30-60 days prior to enrollment) * Aspartate and alanine aminotransferases (AST, ALT) =\< 2.5 x upper limit of normal (ULN) (within 30-60 days prior to enrollment) * Total bilirubin =\< 2 x ULN (except patients with documented Gilbert?s syndrome) (within 30-60 days prior to enrollment) * Creatinine \< 2 mg/dL (or a glomerular filtration rate \> 45) (within 30-60 days prior to enrollment) * Must be willing and able to accept at least one leukapheresis procedure * Must be willing and able to provide written informed consent Exclusion Criteria: * Inability to purify \>= 1 x 10\^7 T cells from leukapheresis product * Previously known hypersensitivity to any of the agents used in this study; known sensitivity to cyclophosphamide or fludarabine * Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol. Patients who have received anti-CD19 CAR T-cells will be excluded from this trial. Consistent with current trials, patients may otherwise be given bridging therapy at the discretion of the lead study investigator * Patients who have received an allograft transplant will NOT be allowed to participate in the trial. Patients who have received an autologous transplant will not be excluded and may participate in the trial * Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment (inhaled or topical steroids at standard doses are allowed) * Human immunodeficiency virus (HIV) seropositivity or other congenital or acquired immune deficiency state, which would increase the risk of opportunistic infections and other complications during chemotherapy-induced lymphodepletion. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist * Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol * Known clinically active brain metastases. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment and there are no neurological signs of potential brain metastases. A brain magnetic resonance imaging (MRI) scan taken within 60 days of screening may be used, otherwise a brain MRI must be performed to confirm absence of brain metastases * A Tiffeneau-Pinelli index \< 70% of the predicted value. Subjects will be excluded if pulmonary function tests indicate they have insufficient pulmonary capability * A left ventricular ejection fraction as determined by an echocardiogram lower than 40% would preclude participation * Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and for 6 months afterwards. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) at screening and again within 14 days from starting the conditioning chemotherapy. The definition of effective contraception will be based on the judgment of the study investigators. Patients who are breastfeeding are not allowed on this study * History of other malignancy in the past 3 years with the following exceptions: * Malignancy treated with curative intent and no known active disease * Adequately treated non-melanoma skin cancer without evidence of disease * Adequately treated cervical carcinoma in situ without evidence of disease * Adequately treated breast ductile carcinoma without evidence of disease * Prostate cancer with a Gleason score less than 6 with undetectable prostate specific antigen over 12 months * Adequately treated urothelial non-invasive carcinoma or carcinoma in situ * Similar neo-plastic conditions with an expectation of greater than 95% disease free survival
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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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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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