huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin L… (NCT03103971) | Clinical Trial Compass
TerminatedPhase 1
huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
Stopped: Terminated due to slow enrollment and end of funding
United States55 participantsStarted 2017-11-03
Plain-language summary
This phase I trial studies the side effects of huJCAR014 in treating patients with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic leukemia. huJCAR014 CAR-T cells are made in the laboratory by genetically modifying a patient's T cells and may specifically kill cancer cells that have a molecule CD19 on their surfaces.
In Stage 1, dose-finding studies will be conducted in 3 cohorts:
1. Aggressive B cell NHL
2. Low burden ALL
3. High burden ALL
In Stage 2, studies may be conducted in one or more cohorts to collect further safety, PK, and efficacy information at the huJCAR014 dose level(s) selected in Stage 1 for the applicable cohort(s). There are two separate cohorts for stage 2:
1. Cohort 2A, CAR-naïve (n=10): patients who have never received CD19 CAR-T cell therapy.
2. Cohort 2B, CAR-exposed (n=27): patients who have previously failed CD19 CAR-T cell therapy.
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:
* Male or female \>= 18 years of age at the time of screening consent
INCLUSION CRITERIA FOR SCREENING
* Diagnosis of R/R B-cell NHL or ALL as defined below:
* Relapsed or refractory B-cell NHL meeting all of the following criteria:
* Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; LBCL transformed from any indolent histology; or primary mediastinal B-cell lymphoma (PMBCL)
* Prior treatment with an anthracycline and rituximab or another CD20-targeted agent (unless the disease is CD20-negative); transformed DLBCL (tDLBCL) must have failed treatment for DLBCL
* At least one of the following:
* Refractory disease after frontline chemo-immunotherapy
* Not eligible for autologous hematopoietic stem cell transplant (auto-HSCT)
* Relapsed or refractory disease after at least 2 lines of therapy or after auto-HSCT
* Relapsed or refractory disease after allogeneic hematopoietic stem cell transplant (allo-HSCT)
* Relapsed or refractory B-cell ALL (patients with Burkitt's lymphoma/leukemia are not eligible)
* All B-ALL patients must have detectable disease by morphology, flow cytometry, cytogenetic analysis (e.g. polymerase chain reaction \[PCR\], fluorescence in situ hybridization \[FISH\], karyotyping) or imaging (e.g. positron emission tomography \[PET\]/computed tomography \[CT\]) or a high likelihood of active disease
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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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Incidence of toxicity
Timeframe: Up to 30 days after the final dose of study therapy
2
Dose-limiting toxicity (DLT) rates
Timeframe: Up to 28 days
3
Maximum concentration (Cmax) of autologous human anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ T-lymphocytes (huJCAR014) cells in blood
Timeframe: Up to 28 days
4
Time to maximum concentration (Tmax), of huJCAR014 cells in blood