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Completed

NCT Number: NCT04488354

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells

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Key information

Conditions

Relapsed/Refractory B-cell Lymphomas Blood Protein Disorders Burkitt Lymphoma Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia (CLL) DNA Virus Infections Diffuse Large B-Cell Lymphoma (DLBCL) Disease Attributes Epstein-Barr Virus Infections Follicular Lymphoma (FL) Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoplasmacytic Lymphoma Lymphoproliferative Disorders Mantle Cell Lymphoma (MCL) Marginal Zone Lymphoma (MZL) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Mediastinal Large B Cell Lymphoma Small Lymphocytic Lymphoma (SLL) Transformed Follicular Lymphoma Tumor Virus Infections Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope National Medical Center, Duarte, California, United States

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About this study

Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT04450069 or any protocol in which patients were administered CLBR001. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post CLBR001 infusion and will continue to be monitored for safety, immunogenicity, and efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients who received at least one CLBR001 cell dose and have either discontinued early or completed the core treatment protocol or any protocol such as a managed access protocol as applicable.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion criteria

  • There are no specific exclusion criteria for this study

Treatment and study plan

CLBR001 and SWI019

Combination Product

No study drug is administered in this study. Patients who have received CLBR001 autologous CAR-T cells will be evaluated in this trial for long-term safety and efficacy

Primary outcomes

  1. Incidence and duration of new adverse events, late onset adverse events, and events of special interest

    Time frame: 15 years

    To measure the incidence and duration of new adverse events, late onset adverse events, and events of special interest

  2. Incidence and duration of new serious adverse events

    Time frame: 15 years

    To measure the incidence and duration of new serious adverse events

  3. Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001

    Time frame: 15 years

    The measure the incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001

  4. Incidence of new malignancies

    Time frame: 15 years

    The measure the incidence of new malignancies

Secondary outcomes

  1. Overall response

    Time frame: 15 years

    To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017

  2. Duration of response

    Time frame: 15 years

    To evaluate clinical efficacy by measuring the duration of response

  3. Progression free survival

    Time frame: 15 years

    To evaluate clinical efficacy by measuring progression free survival

  4. Proportion of patients undergoing stem cell transplant

    Time frame: 15 years

    To evaluate the proportion of patients undergoing stem cell transplant

  5. Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens

    Time frame: 3, 6, 9,12 and 24 months

    To measure the number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens

  6. Detectable replication competent lentivirus (RCL)

    Time frame: 15 years

    To measure detectable replication competent lentivirus (RCL)

  7. Titer of anti-drug antibody (ADA) for CLBR001 and SWI019

    Time frame: 3, 6, 12 months

    To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019

  8. Duration of detection of ADA for CLBR001 and SWI019

    Time frame: 3, 6, 12 months

    To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019

Sponsors and collaborators

Lead sponsor

Calibr, a division of Scripps Research

Other

Registry information

Official study title

A Study to Evaluate the Long-Term Safety of CLBR001, A Lentiviral Based Chimeric Antigen Receptor, In Patients With B-Cell Malignancies Previously Administered CLBR001

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2020
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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