OncoMatch/Clinical Trials/NCT06014073
TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-NHL
Is NCT06014073 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T cell (ATHENA CAR-T) and Fludarabine for non hodgkin's lymphoma.
Treatment: TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T cell (ATHENA CAR-T) · Fludarabine · Cyclophosphamide — ATHENA chimeric antigen receptor (CAR)-T, a CD19-directed CAR-T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL). The cells are from healthy adult volunteer donors that are knocked out of TRAC and Power3 (SPPL3) genes ex vivo using CRISPR-Cas9 gene editing components. In this study, a second-generation anti-CD19 CAR prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together with intracellular CD28 co-stimulatory and CD3ζ signaling domains linked by a CD28 sequence comprising the hinge and transmembrane domains. This is a single center, prospective, open-label, single-arm, phase 1/2 study. A total of around 30 patients with r/r B-cell NHL will be enrolled in the study and receive allogeneic CD19-CAR-T cell infusion. Phase 1 (n=6 to 18) is a dose escalation part, and phase 2 (n=10 to 12) is a expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of ATHENA CAR-T cell therapy in patients with r/r B-cell NHL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive (detected by immunohistochemistry [IHC])
CD19 positive (detected by immunohistochemistry [IHC])
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: MYC 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
For MCL, prior therapy must have included: Anthracycline or bendamustine-containing chemotherapy
Must have received: bendamustine-containing chemotherapy — MCL
For MCL, prior therapy must have included: Anthracycline or bendamustine-containing chemotherapy
Must have received: anti-CD20 monoclonal antibody — MCL
For MCL, prior therapy must have included: Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative)
Must have received: Bruton's tyrosine kinase inhibitor — MCL
For MCL, prior therapy must have included: Bruton's tyrosine kinase inhibitor (BTKi)
Must have received: anti-CD20 monoclonal antibody — other types
For other types, prior therapy must have included: Anti-CD20 monoclonal antibody (unless investigator determines that tumor is CD20-negative)
Must have received: anthracycline-containing chemotherapy — other types
For other types, prior therapy must have included: Anthracycline containing chemotherapy regimen
Cannot have received: CD19 targeted therapy
Prior CD19 targeted therapy
Cannot have received: CAR-T therapy
Prior CAR-T therapy or other genetically modified T cell therapy
Cannot have received: genetically modified T cell therapy
Prior CAR-T therapy or other genetically modified T cell therapy
Cannot have received: autologous stem cell transplant
Exception: within 3 months of planned ATHENA CAR-T infusion
Autologous stem cell transplant with therapeutic intent within 3 months of planned ATHENA CAR-T infusion
Cannot have received: allogeneic stem cell transplant
History of allogeneic stem cell transplantation
Lab requirements
Blood counts
ANC ≥ 1 x 10^9/L, Platelet count ≥50 x 10^9/L, hemoglobin (Hgb) ≥ 80g/L (hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions above)
Kidney function
Serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL/min
Liver function
ALT/AST ≤ 3x ULN; Total bilirubin ≤ 1.5x ULN, except in subjects with Gilbert's syndrome
Cardiac function
Ejection fraction ≥ 50%, no evidence of pericardial effusion by ECHO, no clinically significant ECG findings
Adequate renal, hepatic, pulmonary and cardiac function defined as: Serum creatinine≤1.5 ULN or creatinine clearance ≥ 60 mL/min. ALT/AST ≤ 3 ULN; Total bilirubin ≤ 1.5 ULN, except in subjects with Gilbert's syndrome. Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings. Coagulation Function: INR ≤ 1.5x ULN, and APTT ≤ 1.5x ULN. Baseline oxygen saturation >91% on room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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