An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative Disorders

NCT06721598 | Not Yet Recruiting

• 1 other identifier: HemC101-01-02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This follow-up study is designed to evaluate the long-term safety and effectiveness of a treatment called anti-CD19 CAR-T cell therapy in adults with certain B-cell blood cancers. These cancers include types that have returned after treatment or have not responded to other therapies. CAR-T cell therapy involves using a patient's own immune cells, which are modified in a lab to specifically target and destroy cancer cells with a marker called CD19. The study will look at how well patients tolerate this treatment over time, as well as its ability to keep cancer in remission or reduce its severity. Patients who have previously received CAR-T therapy in an earlier clinical trial and meet specific criteria can participate in this study. The research will include regular follow-up visits over approximately 11 months to monitor for side effects, assess cancer response, and track the activity of CAR-T cells in the body. This study does not involve additional treatments but focuses on understanding the long-term outcomes of CAR-T therapy to provide better care for patients in the future.

Conditions

Non-Hodgkin Lymphoma, B-cell; Acute Lymphoblastic Leukemia ALL

Keywords

CAR-T; B-cell lymphoma; non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

• 1. Incidence of Treatment-Emergent Adverse Events [Safety]

  Frequency of any adverse events (AEs) reported during the study period and AE characterization (severity, seriousness, etc.)

  11 month starting on the 29th day after IMP administration

• ORR [Efficacy]

  Overall response rate (ORR) defined as the proportion of subjects with complete response (CR) or partial response (PR)

  11 month starting on the 29th day after IMP administration

Study Arms (1)

Hem101 Arm

Subjects received Hem101 in Study Hem101-01-01 will be followed for 11 month

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have received the IMP in the HemC101-01-01 study and completed it per protocol

You may qualify if:

• Successful completion of the HemC101-01-01 study procedures.
• Negative pregnancy test for women of reproductive potential.

You may not qualify if:

• The use of therapeutic interventions prohibited by the protocol (glucocorticosteroids, allogeneic cell therapy, GVHD therapy, chemotherapy, alemtuzumab, clofarabine, cladribine, and biologics derived from mouse materials).
• Non-adherence to HemC101-01-01 study procedures that, in the investigator's opinion, put the patient at risk if they participate in the study and may significantly bias the assessment of study results.
• Any clinically relevant data that, in the investigator's opinion, affects the patient's ability to enter the study and puts the patient at risk.

Sponsors & Collaborators

• National Research Center for Hematology, Russia: lead

Study Sites (1)

National Medical Research Center for Hematology

Moscow, 125167, Russia

Location

Related Links

• Offical approval of the trial by the Ministry of Health of the Russian Federation

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Central Study Contacts

Clinical Trial Information Processing Team

CONTACT

+74956124551; clinicaltrials@bk.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: January 9, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)