Humanized CD19-Specific CAR T Cells for the Treatment of Patients With Positive Relapsed or Refra… (NCT06447987) | Clinical Trial Compass
SuspendedPhase 1
Humanized CD19-Specific CAR T Cells for the Treatment of Patients With Positive Relapsed or Refractory CD19 Positive B-Cell Acute Lymphoblastic Leukemia
Stopped: Pending Interim Analysis
United States24 participantsStarted 2024-11-06
Plain-language summary
This phase Ib trial tests the safety, side effects, and effectiveness of humanized (hu)CD19-chimeric antigen receptor (CAR) T cell therapy in treating patients with CD19 positive B-cell acute lymphoblastic leukemia (ALL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy is a treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as CD19, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the huCD19 positive CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. huCD19-CAR T cell therapy may be safe, tolerable and effective in treating patients with relapsed or refractory CD19 positive ALL.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented informed consent of the participant
* Agreement to allow the use of archival tissue from diagnostic tumor biopsies.
* If unavailable, exceptions may be granted with study principal investigator (PI) approval
* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed. However, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
* Age: ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) 0-2 / Karnofsky performance status (KPS) ≥ 70
* Histologically confirmed CD19+ relapsed/refractory ALL with at least 2 prior lines of therapy
* Prior alloHCT \> 100 days prior to enrollment may be considered a prior line of therapy
* Research participants with confirmed 1st or higher relapse of disease by morphology, cytogenetics or molecular, or research participants with refractory or residual disease
* Participants with central nervous system (CNS) involvement by leukemia (CNS2 and CNS3) may be considered eligible after discussions with the study team
* Patients with only MRD+ disease may be eligible
* Patients with isolated extramedullary disease may also be eligible
* Total bilirubin ≤ 2.0 X upper limit of normal (ULN) (unless has Gilbert's disease or rela…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is currently suspended, can you find out why it's suspended and whether there's any timeline for it reopening — and how that affects our planning right now?
2This is a Phase 1 trial focused on measuring dose-limiting toxicity, which means it's primarily about finding a safe dose rather than proving the treatment works — given that, how does the level of uncertainty here compare to already-approved CAR T-cell therapies for my type of leukemia?
3CAR T-cell therapy can cause serious side effects like cytokine release syndrome — what would you want to monitor closely, and what does the fact that this uses a 'humanized' version of the CD19 CAR T cell mean for my risk profile compared to other CAR T approaches?
4Since my leukemia is relapsed or refractory, are there currently approved CAR T-cell therapies or other standard treatments we should try first before considering an experimental Phase 1 study like this one?
5If this trial does reopen and I were to be considered for it, what would the treatment schedule and follow-up demands look like in terms of hospital stays, travel, and time commitment for our family?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.