Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma

NCT06180174 | Recruiting Phase 1

• 1 other identifier: PB10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma.

Conditions

B Cell Lymphoma; Non Hodgkin Lymphoma

Keywords

CAR-T; CD19

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)

  1 month

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Dose-limiting toxicity after CD19 CAR-T cell infusion

  1month

Secondary Outcomes (9)

• Assessing objective response rate(ORR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]

  3 months

• Assessing best overall response rate(BOR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]

  3 months

• Assessing best complete response rate(CRR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]

  3 months

• Assessing best partial response rate(PRR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]

  3 months

• AUCS of MC-1-50 cell preparation [Cell dynamics]

  3 months

Other Outcomes (5)

• Objective response rate (ORR) of MC-1-50 cell treatment in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]

  2 years

• Duration of Response (DOR) of MC-1-50 cell treatment in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]

  2 years

• Progress-free survival(PFS) of MC-1-50 cell treatment in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]

  2 years

Study Arms (1)

MC-1-50 cell preparation

EXPERIMENTAL

Patients will be be treated with CD19 CAR- T cells

Biological: MC-1-50

Interventions

MC-1-50 BIOLOGICAL

A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion

MC-1-50 cell preparation

Eligibility Criteria

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

You may qualify if:

• The patient or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study;
• Age ≥18 years old, gender unlimited;
• Confirmed cytological or histological diagnosis of B-cell non-Hodgkin lymphoma according to WHO 2017 criteria, including the following pathological types:
• Diffuse large B-cell lymphoma: including non-specific type (DLBCL, NOS), chronic inflammatory associated DLBCL, primary cutaneous DLBCL (leg type), EBV-positive DLBCL (NOS);
• High-grade B-cell lymphomas (including NOS and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements);
• Primary mediastinal large B-cell lymphoma;
• Rich T/ histiocytic large B-cell lymphoma;
• Transformed DLBCL (e.g., transformed DLBCL of follicular lymphoma, chronic lymphocytic leukemia/small B lymphocytic lymphoma, marginal zone lymphoma, etc.);
• Grade 3b follicular lymphoma (FL3b);
• Have received adequate treatment with CD20 monoclonal antibody and anthracyclines in the past (except for those who are negative for CD20 and anthracyclines, or who are unable to tolerate or adapt to CD20 monoclonal antibody therapy or have other conditions in which the use of CD20 monoclonal antibody is not considered appropriate by the investigators), For those who are allergic to CD20 monoclonal antibody, or have intolerable serious adverse reactions after use, or have active infections and serious cardiovascular problems, etc.), the definition of relapse or refractory is met during screening:
• Recurrence: recurrence of disease progression or recurrence after achieving CR with standard treatment;
• Difficult to treat: The best curative effect after at least 4 courses of first-line treatment/at least 2 courses of end-line treatment (2 lines and more) is disease stabilization (SD), and the SD maintenance time after the last dose is not more than 6 months; Or the best response to the last treatment was disease progression (PD);
• No remission, disease progression or recurrence after autologous hematopoietic stem cell transplantation;
• Patients with transformational lymphoma who received chemotherapy prior to transformation and did not go into remission, disease progression, or relapse after salvage therapy after transformation.
• Immunohistochemical or flow cytometry results showed positive CD19 expression;

You may not qualify if:

• Secondary CNS lymphoma was allowed to be included, except those with active CNS invasion or symptoms of CNS involvement or primary CNS lymphoma at the time of screening;
• Patients who have received CAR-T therapy or other gene-modified cell therapy before screening;
• Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) before screening;
• Received the following anti-tumor therapy before cell infusion: received chemotherapy, targeted therapy and other drug treatment (preconditioning) within 14 days or at least 5 half-lives (whichever is longer)
• Except for therapy and sheath chemotherapy for CNS lymphoma, which should be stopped 1 week before cell infusion); Received radiation within 14 days;
• Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA detection greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive; Cytomegalovirus (CMV) DNA test positive;
• Have any of the following heart conditions:
• New York Heart Association (NYHA) Stage III or IV congestive heart failure;
• Had myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;
• A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);
• History of severe non-ischemic cardiomyopathy;
• Active or uncontrollable infection requiring systemic treatment exists within 1 week prior to screening;
• Grade 2 to 4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD were present within 4 weeks prior to screening;
• Cerebrovascular accident or seizure occurred within 6 months before screening;
• Occurrence of deep vein or deep artery embolization events within 6 months before screening;

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuqin Song, M.D

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqin Song, M.D

CONTACT

88196118; songyq_vip@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: December 31, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

CN (1)