Actively Recruiting
TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-NHL
Led by Chinese PLA General Hospital · Updated on 2025-05-25
30
Participants Needed
3
Research Sites
155 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
P
Peking University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years inclusive
- Histologically confirmed refractory or relapsed B-cell non-Hodgkin's lymphoma of specified subtypes
- Relapsed disease defined as progression after achieving remission with latest treatment
- Refractory disease defined by lack of complete response to first-line therapy or progression after autologous stem cell transplant
- Intolerance to standard treatment as judged by investigator
- Received adequate prior therapy including specific chemotherapy and antibody regimens
- At least one measurable lesion meeting size criteria
- CD19 positive by immunohistochemistry
- Stable toxicities from prior therapy with recovery to Grade 1 or less
- ECOG performance status of 2 or less
- Adequate blood counts including neutrophils, platelets, and hemoglobin
- Adequate kidney, liver, lung, and heart function within specified laboratory limits
- Willingness to practice birth control from consent through 6 months after conditioning chemotherapy
- Females of childbearing potential with negative pregnancy test
- Voluntary informed consent
You will not qualify if you...
- Expected survival less than 3 months
- History of malignancy other than certain skin cancers or carcinoma in situ unless disease-free for 3 years
- Autologous stem cell transplant within 3 months before planned infusion
- History of allogeneic stem cell transplantation
- Prior CD19 targeted therapy or CAR-T/genetically modified T cell therapy
- Recent chemotherapy, targeted drugs, monoclonal antibodies, or radiotherapy within specified timeframes before lymphodepletion
- Detectable malignant cells in cerebrospinal fluid, brain metastases, or history of CNS lymphoma
- Severe hypersensitivity to lymphodepletion drugs or ATHENA CAR-T components
- Uncontrolled infections requiring IV antimicrobials
- Active infectious diseases including HIV, hepatitis B or C, EBV, CMV
- History of CNS disorders or autoimmune disease with CNS involvement
- Cardiac involvement by lymphoma or significant cardiac disease within 12 months
- Requirement for urgent therapy due to oncologic emergency
- Primary immunodeficiency
- Autoimmune disease causing organ injury or requiring immunosuppression within 2 years
- Recent deep vein thrombosis or pulmonary embolism requiring anticoagulation
- Any condition interfering with safety or efficacy assessments
- Vaccination within 6 weeks prior to conditioning
- Unlikely to complete study visits or comply with protocol as judged by investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Biotherapeutic Department, Chinese PLA General Hospital
Beijing, China
Actively Recruiting
2
EdiGene Inc
Beijing, China
Actively Recruiting
3
School of Life Sciences, Peking University
Beijing, China
Actively Recruiting
Research Team
W
Weidong Han, Ph.D
CONTACT
Y
Yang liu, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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