OncoMatch/Clinical Trials/NCT05554939
Allogenic CD19-targeting CAR-γδT Cell Therapy in R/R NHL
Is NCT05554939 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Non-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)
Demographics
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.
Frequently asked questions
Is NCT05554939 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplantation, organ transplantation, radiotherapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages