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 2026-03-01
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 range18 Years
SexALL
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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…
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