CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-… (NCT07763938) | Clinical Trial Compass
Not Yet RecruitingPhase 1
CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies
China80 participantsStarted 2026-11-01
Plain-language summary
Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in the Treatment of Relapsed/Refractory B-cell Malignancies
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
. Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.
. Age greater than or equal to 18.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. At least one measurable tumor lesion.
. Eligible subjects shall meet the criteria and qualification requirements of any one of the expansion cohorts as follows:
. Prior antitumor therapy with insufficient washout period ;
. Prior treatment with lentiviral vector-based gene therapies;
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, severity, and category of treatment-emergent adverse events (TEAEs)
Timeframe: Through study completion, an average of 2 years afterCD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
2
Objective response rate (ORR) and complete response (CR) rate (or the proportion of subjects achieving very good partial response [VGPR] or better) assessed per protocol-specified efficacy evaluation criteria stratified by disease type
Timeframe: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Trial details
NCT IDNCT07763938
SponsorThe First Affiliated Hospital with Nanjing Medical University
. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).
. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).