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 (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Non-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)
Demographics
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.
Frequently asked questions
Is NCT06014073 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD19 targeted therapy, CAR-T therapy, genetically modified T cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 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.
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