Cellular Immunotherapy for Relapsed or Refractory Lymphoma Data Collection

NCT06541327 | Recruiting

• 1 other identifier: CCIC-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to collect clinical data from adult patients with relapsed or refractory non-Hodgkin's lymphoma (r/r NHL) receiving cellular immunotherapy to establish a large database of cellular immunotherapy for Chinese patients.

Conditions

Lymphoma, Non-Hodgkin

Keywords

CAR-T

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate in 3 months

  Complete Response rate in 3 months is defined as the incidence of subjects achieving complete remission (CR) within 3 months after CAR-T infusion according to the Lugano Classification (Cheson et al, 2014), as determined by study investigators.

  3 months post CAR-T infusion

Secondary Outcomes (3)

• Objective remission rate (ORR) in 3months

  3 months post CAR-T infusion

• Overall Survival (OS)

  2 years post CAR-T infusion

• Adverse events (AEs)

  2 years post CAR-T infusion

Study Arms (1)

CAR-T

Chimeric antigen receptor modified T cells

Drug: Chimeric Antigen Receptor

Interventions

Chimeric Antigen Receptor DRUG

CAR-T

Also known as: Chimeric antigen receptor modified T cells

CAR-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with relapsed or refractory lymphoma receiving cellular immunotherapy

You may qualify if:

• Adult patients with a confirmed diagnosis of r/r B-NHL (including r/r DLBCL, r/r FL, r/r MCL, HGBL-NOS, FL3b, r/r MZL, transformed lymphomas such as MCL) and r/r T-cell lymphoma, who have received informed consent waivers;
• Patients who have received or are receiving cellular immunotherapy, with cellular immunotherapy products including the following categories: cytokine-induced killer cell therapy (CIK), tumor-infiltrating lymphocytes (TIL), cytokine-induced killer cell-dendritic cell mixed therapy (DC-CIK), chimeric antigen receptor T cells, NK cells or macrophage therapy (CAR-T, CAR-NK, CAR-M), T-cell receptor chimeric T cell therapy (TCR-T), dendritic cell therapy.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Receptors, Chimeric Antigen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Receptors, Artificial; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Antigen, T-Cell; Receptors, Antigen; Receptors, Immunologic; Receptors, Cytoplasmic and Nuclear

Central Study Contacts

Weili Zhao

CONTACT

+862164370045; zwl_trial@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 7, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CN (1)