Decitabine-primed Tandem CD19/CD20 CAR T Cells Treatment in r/r B-NHL (NCT04697940) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Decitabine-primed Tandem CD19/CD20 CAR T Cells Treatment in r/r B-NHL
China33 participantsStarted 2021-04-15
Plain-language summary
This is an open-label, phase 1/2 study has the primary objective of decitabine-primed tandem CART 19/20 in patients with B-NHL who were confirmed as r/r B cell Non-Hodgkin's Lymphoma. A total of 19 to 33 patients are planned to be enrolled and receive decitabine-primed tandem CART 19/20 cell infusion. Phase 1 (9 to 18 cases) is dose escalation part, and phase 2 (10 to 15 cases) is expansion cohort part.
Who can participate
Age range
18 Years – 75 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:
Patients eligible for inclusion in this study had to meet all of the following criteria:
* Age ≥18 and ≤75 years.
* Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2.
* Patients with histologically confirmed CD20+ and/or CD19+ B-cell NHL, including the following types defined by the World Health Organization (WHO) 2016:
* Diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), including Activated B-cell type (ABC) / Germinal center B-cell Type (GCB);
* Primary mediastinal (thymic) large B-cell lymphoma (PMBCL);
* Transformed follicular lymphoma (TFL);
* High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (HGBCL);
* Follicular lymphoma (FL);
* Mantle cell lymphoma (MCL) \[pathologically confirmed, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1\];
* Marginal zone lymphoma (MZL), including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue (MALT) lymphoma.
* Relapse after treatment with ≥2 lines systemic therapy for all the above disease types, or refractory disease for aggressive types (DLBCL-NOS, PMBCL, TFL and HGBCL). Relapse disease is defined as disease progression after last regimen. Refractory disease is defined as no CR to first-line therapy:
* PD as best response to first-line therapy, or
* SD as best response after at least 4 cycles of first-line therapy …
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
Phase 1: Incidence of Adverse Events (AEs)
Timeframe: 12 months
2
Phase 1: Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: First infusion date of CAR T cells up to 28 days