OncoMatch/Clinical Trials/NCT05554939
Allogenic CD19-targeting CAR-γδT Cell Therapy in R/R NHL
Is NCT05554939 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Allogenic CD19 CAR-γδT cell and Fludarabine for non hodgkin's lymphoma.
Treatment: Allogenic CD19 CAR-γδT cell · Fludarabine · Cyclophosphamide — This is a single center, prospective, open-label, single-arm, phase 1/2 study for patients with r/r B-cell NHL to evaluate the safety and efficacy of gene edited allogenic CD19 CAR-γδT cells. The cells are from healthy adult volunteer donors that are gene edited ex vivo using CRISPR-Cas9 to weaken HLA expression and further to overcome host immune system rejection (HvGR). In this study, a second generation anti-CD19 CAR prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together with intracellular 4-1BB co-stimulatory and CD3ζ signaling domains linked by a CD8α sequence comprising the hinge and transmembrane domains. A total of around 30 patients with r/r B-cell NHL will be enrolled in the study and receive allogeneic CD19 CAR-γδT cell infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of allogeneic CD19 CAR-γδT cell therapy in patients with r/r B-cell NHL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hodgkin Lymphoma
Biomarker criteria
Required: CD19 overexpression (positive)
histologically confirmed CD19-positive B-cell NHL
Allowed: MYC rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (HGBCL)
Allowed: BCL2 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (HGBCL)
Allowed: BCL6 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (HGBCL)
Allowed: CCND1 overexpression
Mantle cell lymphoma (MCL)...overexpress cyclin D1
Allowed: IGH t(11;14)(q13;q32)
Mantle cell lymphoma (MCL)...chromosome translocation t(11;14)(q13;q32)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline-containing chemotherapy — MCL or other types
Anthracycline or bendamustine-containing chemotherapy
Must have received: bendamustine-containing chemotherapy — MCL
Anthracycline or bendamustine-containing chemotherapy
Must have received: anti-CD20 monoclonal antibody — all types unless CD20-negative
Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative)
Must have received: Bruton's tyrosine kinase inhibitor — MCL
Bruton's tyrosine kinase inhibitor (BTKi)
Cannot have received: allogeneic hematopoietic stem cell transplantation
History of allogeneic hematopoietic stem cell transplantation
Cannot have received: organ transplantation
organ transplantation
Cannot have received: radiotherapy
Received radiotherapy within 3 months before enrollment
Cannot have received: immunotherapy (anti-programmed death 1 (PD-1) antibody, anti-programmed death ligand 1 (PD-L1) antibody, CD19/CD3-bispecific antibody)
Received immunotherapy drugs within 4 weeks before enrollment, such as anti-programmed death 1 (PD-1) antibody, anti-programmed death ligand 1 (PD-L1) antibody, CD19/CD3-bispecific antibody, and so on
Cannot have received: immunocellular therapy
Patients who received any immunocellular therapy within 3 months before enrollment
Cannot have received: allogeneic cell therapy
Received allogeneic cell therapy within 6 weeks prior to enrollment, such as donor lymphocyte infusion
Lab requirements
Blood counts
hemoglobin (hgb) ≥80g/l, neutrophil count≥1×10^9/l, platelet (plt) ≥75×10^9/l
Kidney function
serum creatinine ≤1.5 × upper limit of normal range (uln) or endogenous creatinine clearance ≥45ml/min (cockcroft-gault formula)
Liver function
alt/ast ≤3 times uln, total bilirubin ≤1.5× uln
Cardiac function
echocardiography showed left ventricular ejection fraction ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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