Safety and Efficacy of KSVCBD Injection in B-cell Non-Hodgkin's Lymphoma Expressing CD19 and/or BCMA (NCT07620314) | Clinical Trial Compass
RecruitingPhase 1
Safety and Efficacy of KSVCBD Injection in B-cell Non-Hodgkin's Lymphoma Expressing CD19 and/or BCMA
China9 participantsStarted 2026-06-15
Plain-language summary
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) CD19 and/or BCMA.
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
. Age 18-75 years (inclusive), any gender.
. Subjects must meet the following diagnostic and treatment criteria:
.1Histologically or cytologically confirmed B-NHL (according to the 2016 WHO classification of lymphoid neoplasms):
.2Subjects must be in a relapsed or refractory state during the screening period:
.3Subjects judged by the investigator to be intolerant to standard therapy may also be included in the study.
. Intranodal lesion with long-axis diameter \> 1.5 cm, or extranodal lesion with long-axis diameter \> 1.0 cm (according to the 2014 Lugano response criteria).
. Positive expression of CD19 and/or BCMA in tumor tissue confirmed by flow cytometry and/or histopathology (previous pathology or flow cytometry diagnosis of CD19 and/or BCMA in the patient, as confirmed by the investigator, is acceptable). For subjects who have previously received anti-CD19 and/or anti-BCMA therapy, a tumor biopsy should be performed to confirm current positive expression of CD19 and/or BCMA.
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
Dose limited toxicity (DLT)
Timeframe: Within 28 days post-infusion
2
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Within 24 months post-infusion
3
Incidence and severity of adverse events of special interest (AESI)
. Toxicities from any prior therapy must be stable and have resolved to ≤ Grade 1 (excluding hematologic toxicities and clinically insignificant toxicities such as alopecia).
Exclusion criteria
. Expected survival \< 3 months.
. History of or concurrent active malignancy. Exceptions include: carcinoma in situ of the cervix that has been cured or with no recurrence for at least 3 years, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery.
. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT) or autologous HSCT within 3 months prior to KSVCBD infusion.