Study of LUCAR-20S in Patients With R/R NHL

NCT04176913 | Terminated Phase 1

• 1 other identifier: BM2L201904
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

An open label, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LUCAR-20S CAR-T cells in relapsed or refractory CD20+ diffuse large B-cell, follicular, mantle cell and small lymphocytic lymphoma.

Conditions

Diffuse Large B Cell Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicity (DLT)

  DLT assessed by NCI-CTCAE 5.0

  30 days post infusion

• Adverse events

  Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0

  90 days post infusion

• Concentration of Pharmacokinetics in blood

  PK CAR positive T cells in peripheral blood, PK CAR transgene levels in peripheral blood

  through study completion, 2 years after infusion of the last subject

• Concentration of Pharmacokinetics in bone marrow

  PK CAR positive T cells in bone marrow, PK CAR transgene levels in bone marrow

  through study completion, 2 years after infusion of the last subject

Secondary Outcomes (6)

• Recommended Phase II dose (RP2D)

  30 days post infusion

• Overall response rate (ORR) after administration

  3 months post infusion

• Time to Response (TTR) after administration

  3 months post infusion

• Duration of remission (DOR) after administration

  through study completion, 2 years after infusion of the last subject

• Progress Free Survival (PFS) after administration

  through study completion, 2 years after infusion of the last subject

Study Arms (1)

Anti-CD20 Allogeneic CAR-T Cell Therapy

EXPERIMENTAL

An open label, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LUCAR-20S CAR-T cells in relapsed or refractory CD20+ diffuse large B-cell, follicular, mantle cell and small lymphocytic lymphoma.

Drug: LUCAR-20S CAR-T cells

Interventions

LUCAR-20S CAR-T cells DRUG

An Anti-CD20 Allogeneic CAR-T Cell Therapy in Patients with Relapsed/Refractory Diffuse Large B-Cell, Follicular, Mantle Cell or Small Lymphocytic Lymphoma

Anti-CD20 Allogeneic CAR-T Cell Therapy

Eligibility Criteria

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

You may qualify if:

• Signed informed consent form (ICF)
• Age 18 Years to 75 Years
• Pathological diagnosis of refractory/relapsed CD20+ non-Hodgkin's lymphoma (one of the following):
• Diffuse large B-cell lymphoma (DLBCL)
• Follicular lymphoma (FL)
• Mantle cell lymphoma (MCL)
• Small lymphocytic lymphoma (SLL)
• Measurable disease as defined by 2014 Lugano criteria at Screening
• Refractory/relapsed disease after standard-of- care treatment as following (Undergone at least 2 complete cycle of therapy for each line, unless PD been documented as the best response to the regimen) and not eligible or appropriate for HSCT (Auto/allo). Subject must have documented evidence of progressive disease on or within 12 months of their last regimen.
• DLBCL: Refractory/relapsed after at least 1 prior line of therapy, must have been treated with anti-CD20 monoclonal antibody
• FL: Refractory/relapsed after at least 2 prior lines of therapy, must have been treated with anti-CD20 monoclonal antibody
• MCL: Refractory/relapsed after at least 2 prior lines of therapy
• SLL: Refractory/relapsed after at least 2 prior lines of therapy
• Laboratory criteria at Screening
• ① Blood routine: NE≥1.0×109/L；HGB≥8g/dL；PLT≥50×109/L

You may not qualify if:

• Any malignancy besides the NHL categories under study, exceptions include
• Any other malignancy curatively treated and disease-free for at least 2 years prior to enrollment
• History of non-melanoma skin cancer with sufficient treatment and currently no evidence of recurrence
• Prior treatment with an allogeneic stem cell transplant
• Prior treatment with genetic therapy
• Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed at CD20 target
• Those 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), and human immunodeficiency virus antibody (HIV-Ab)
• Prior antitumor therapy with insufficient washout period
• Targeted therapy, epigenetic therapy, experimental drug therapy or experimental invasive treatment with medical apparatus and instruments 14 days or five half-lives, whichever is shorter before lymphodepletion
• Use of monoclonal antibodies 21 days prior to lymphodepletion
• Chemotherapy within 14 days prior to lymphodepletion
• Radiotherapy within 14 days prior to lymphodepletion
• Participated in other clinical trials within 30 days prior to lymphodepletion
• With central nervous system involvement
• Women in pregnancy or lactation

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Nanjing Legend Biotechnology Co.,Ltd.; The First Affiliated Hospital of USTC west district; Beijing Boren Hospital: collaborator

Study Sites (3)

Oncology Department，The First Affiliated Hospital of USTC west district

Hefei, Anhui, 230000, China

Location

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, 210029, China

Location

Hematological Department，Beijing Boren Hospital

Beijing, 100070, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Xu, PhD& MD

  The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

  PRINCIPAL INVESTIGATOR

• Kaiyang Ding, PhD& MD

  Anhui Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Kai Hu, PhD& MD

  Beijing Boren Hospital

  PRINCIPAL INVESTIGATOR

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: Chief Physician of hematology department

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 25, 2019
• Study Start: December 1, 2020
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12

Locations

CN (3)