Anti-CD19 CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
This study is testing a new type of treatment called anti-CD19 CAR-T cells for people with certain types of non-Hodgkin lymphoma that have come back or haven't responded to other treatments. You would first receive chemotherapy drugs, Fludarabine and Cyclophosphamide, followed by a single infusion of the anti-CD19 CAR-T cells. Researchers want to see how safe this treatment is and what side effects it might cause. They also want to find the best dose and see how well it works. This study is currently enrolling people with Burkitt Lymphoma who have already had at least one other treatment. The part of the study looking at dose escalation is now closed to new participants.
- Study design
- This is an open-label, pilot, phase 1 study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll 36 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 12 months after the CAR-T cell infusion, which is about 15 months from the start of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Carrie Ho, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Proportion of participants with treatment-emergent adverse events (AEs)From initiation of study treatment to 12 months following CAR-T infusion, approximately 15 months
Participants treated with conforming product who received the target doses of anti-CD19 CAR-T infusion will be included in the analysis. Proportion of participants with treatment-emergent adverse events of CAR-T in B-cell NHL, as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0), revised Cytokine Release Syndrome (CRS) grading criteria, and American Society for Transplantation and Cellular Therapy (ASTCT) immune effector cell (IEC) -associated neurotoxicity syndrome (ICANS) Consensus Grading for Adults (for neurotoxicity grading).
- Proportion of participants who experience a dose-limiting toxicity (DLT) (Dose escalation)From initiation of study treatment to 30 days following CAR-T infusion
A DLT includes AEs graded according to CTCAE version 5.0, with the exceptions of CRS and neurotoxicity, which are graded using CRS and ICANS criteria. DLTs must 1) be suspected to be secondary to CAR-T cell infusion, 2) occur during the first 30 days after infusion and 3) meet the following criteria: 1. Grade 3 or 4 non-hematologic toxicities of any duration, with following exceptions: Grade 3 laboratory abnormalities without associated symptomatology or clinical consequence that resolve in \< 7 days; AEs associated with Grade \<= 2 CRS; Toxicities associated with Grade 3 CRS (except cardiac or pulmonary organ toxicity) that improves to grade \<= 2 within 3 days of intervention; isolated renal or hepatic grade 3 organ toxicity that does not resolve within 7 days; Laboratory abnormalities compatible with tumor lysis syndrome; Grade 4 hematological toxicity that persists at grade \>= 3 despite maximum supportive care for \>21 days.