Clinical trial
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
Name
LB2303-0001
Description
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.
Trial arms
Trial start
2024-05-09
Estimated PCD
2026-06-30
Trial end
2028-06-30
Status
Recruiting
Phase
Early phase I
Treatment
LUCAR-G39D cells product
Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Arms:
LUCAR-G39D cells product
Size
33
Primary endpoint
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)
Pharmacokinetics in peripheral blood
Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1).
Pharmacokinetics in bone marrow
Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)
The recommended Phase II dose (RP2D) for this cell therapy
Within 30 days after LUCAR-G39D infusion
Eligibility criteria
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 33, 'type': 'ESTIMATED'}}
Updated at
2024-05-31
1 organization
1 product
2 indications
Product
LUCAR-G39DIndication
B-Cell Non-Hodgkin Lymphoma RecurrentIndication
B-cell non-Hodgkin lymphoma-refractory