Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Re… (NCT07490275) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases
9 participantsStarted 2026-07-01
Plain-language summary
This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases
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:
* Age ≥18 years (including 18 years), no gender restrictions.
* Confirmed by flow cytometry to express CD19 or BCMA antigen on the surface of peripheral blood B cells.
* Major organ function must meet the following requirements (excluding abnormalities related to active autoimmune disease):
* Bone marrow function: Neutrophil count ≥ 1 × 10\^9/L (no colony-stimulating factor therapy within 2 weeks prior to testing); Haemoglobin ≥ 60 g/L.
* Liver function: Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN) (excluding ALT elevation due to inflammatory myopathy) ; Aspartate Aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy); Total Bilirubin (TBIL) ≤ 2 times ULN (may be relaxed to ≤ 3.0 times ULN for subjects with Gilbert's syndrome).
* Renal function: Creatinine clearance (CrCl) ≥ 30 ml/min (calculated using the Cockcroft-Gault formula, excluding acute CrCl decline due to target disease; lupus nephritis (LN) patients excluded).
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstain from sexual intercourse for at least 6 months during study treatment and for at least 6 months after study treatment completion.
* Voluntary participation in this clinical study, signing of informed consent, good compl…
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.
1This trial is Phase 1 and is primarily measuring safety and toxic side effects — what does that mean for me in terms of how much is actually known about whether this treatment works for my condition?
2The therapy uses 'allogeneic' CAR-T cells, meaning they come from a donor rather than my own body — how does that difference affect my risk of serious reactions compared to standard CAR-T approaches?
3The trial targets both CD19 and BCMA, which are markers found on certain immune cells — given my specific diagnosis, how well does that match what's driving my disease, and would that make me a stronger or weaker candidate to discuss with the research team?
4The trial is listed as 'not yet recruiting' — how long might it realistically be before it opens, and should I be pursuing other treatment options in the meantime rather than waiting?
5Since this trial is for relapsed or refractory autoimmune disease, are there any standard treatments I haven't yet tried that my care team would recommend exhausting before we seriously consider an early-phase experimental therapy like this one?
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
Adverse Event
Timeframe: 6 months
2
Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: First infusion date of allogeneic CD19/BCMA-targeted CAR-γδT cell to 28 days end cell infusion
Trial details
NCT IDNCT07490275
SponsorInstitute of Hematology & Blood Diseases Hospital, China