Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

NCT06395870 | Recruiting Phase 1

• 1 other identifier: LB2303-0001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

B-Cell Non-Hodgkin Lymphoma-Recurrent; B-Cell Non-Hodgkin Lymphoma-Refractory

Outcome Measures

Primary Outcomes (4)

• Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)

  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.

  Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)

• Pharmacokinetics in peripheral blood

  CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39D infusion.

  Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1).

• Pharmacokinetics in bone marrow

  CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39D infusion.

  Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)

• The recommended Phase II dose (RP2D) for this cell therapy

  RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion.

  Within 30 days after LUCAR-G39D infusion

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)

• Progression-free survival (PFS)

  Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)

• Overall Survival (OS)

  Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)

• Time to Response (TTR)

  Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)

• Duration of Response (DoR)

  Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)

Study Arms (1)

LUCAR-G39D cells product

EXPERIMENTAL

Each subject will be given a single-dose LUCAR-G39D cells infusion at each dose level.

Biological: LUCAR-G39D cells product

Interventions

LUCAR-G39D cells product BIOLOGICAL

Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

LUCAR-G39D cells product

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
• 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;
• \. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria

You may not qualify if:

• Subject eligible for this study must not meet any of the following criteria:
• \. 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).
• \. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.
• \. Pregnant or lactating women;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (2)

Oncology Department, The First Affiliated Hospital of USTC west district

Hefei, Anhui, 230000, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, 300060, China

RECRUITING

Central Study Contacts

Huilai Zhang

CONTACT

+86-18622221228; huilaizhangtz@163.com

Kaiyang Ding

CONTACT

13966672170; dingkaiy@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of lymphoma department

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: May 9, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)