A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39P, a Dual-targeted Cell Preparation Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 11
- Locations
- 3
- Primary Endpoint
- Incidence, severity and type of TEAEs
Study Overview
Brief Summary
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma
Detailed Description
his is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39P in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39P injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Aged 18-75 years (inclusive).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD
- •At least one evaluable tumor lesion according to Lugano 2014 criteria.
- •Response to prior therapy is consistent with one of the following:
- •Primary refractory.
- •Relapsed or refractory after 2 or more lines of therapy.
- •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
- •Clinical laboratory values meet screening visit criteria
Exclusion Criteria
- •Subject eligible for this study must not meet any of the following criteria:
- •Prior antitumor therapy with insufficient washout period ;
- •Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy;
- •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-G39P CAR-T cell or its excipients, including DMSO.
- •7. Pregnant or lactating women;
Arms & Interventions
Experimental: LUCAR-G39P cells product
Each subject will be given a single-dose LUCAR-G39P cells infusion at each dose level.
Intervention: LUCAR-G39P cells product (Biological)
Outcomes
Primary Outcomes
Incidence, severity and type of TEAEs
Time Frame: Through study completion , an average of 2 years after LUCAR-G39P 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
Time Frame: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39P infusion
The recommended Phase II dose (RP2D) for this cell therapy
Time Frame: Within 30 days after LUCAR-G39P infusion
RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion
Pharmacokinetics in bone marrow
Time Frame: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39P infusion.
Secondary Outcomes
- Overall Survival (OS)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Time to Response (TTR)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Progression-free survival (PFS)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Duration of Response (DoR)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Overall Response Rate (ORR)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Immunogenicity assessment of LUCAR-G39P cells(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))