Clinical trial NCT06295549: Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Legend Biotech Co.
First posted: 2024-03-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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-G39P CAR-T cell or its excipients, including DMSO.

   7. Pregnant or lactating women;

   -

Primary outcomes:
measure: Incidence, severity and type of TEAEs
timeFrame: Through study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
measure: Pharmacokinetics in peripheral blood
timeFrame: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
measure: Pharmacokinetics in bone marrow
timeFrame: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
measure: The recommended Phase II dose (RP2D) for this cell therapy
timeFrame: Within 30 days after LUCAR-G39P infusion
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
measure: Progression-free survival (PFS)
timeFrame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
measure: Overall Survival (OS)
timeFrame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
measure: Time to Response (TTR)
timeFrame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
measure: Duration of Response (DoR)
timeFrame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
measure: Immunogenicity assessment of LUCAR-G39P cells
timeFrame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Other outcomes:
Locations:
city: Nanjin
country: China
facility: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Beijing
country: China
facility: Beijing Gobroad Hosptial
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jianyong Li, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: