LUCAR-G39D cells product: Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Study summary
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.
Response to prior therapy is consistent with one of the following:
1. Primary refractory.
2. Relapsed or refractory after 2 or more lines of therapy.
3. For LBCL, 3B FL. t-iNHL:
* Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
* Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;
7\. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria
Exclusion Criteria:
Subject eligible for this study must not meet any of the following criteria:
1\. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
6\. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.
7\. Pregnant or lactating women;
Primary outcome measure(s)
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) — Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1) An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Pharmacokinetics in peripheral blood — Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1). CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39D infusion.
Pharmacokinetics in bone marrow — Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1) CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39D infusion.
The recommended Phase II dose (RP2D) for this cell therapy — Within 30 days after LUCAR-G39D infusion RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion.
Trial sites (2)
Facility
City
Region
Status
Oncology Department, The First Affiliated Hospital of USTC west district
Hefei
Anhui
Recruiting
Tianjin Cancer Hospital
Tianjin
China
Recruiting
More Tianjin Medical University Cancer Institute and Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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