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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-09

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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This is a Phase I/II open-label, non-interventional, single-arm follow-up study evaluating the long-term safety and efficacy of anti-CD19 CAR-T cell therapy in adult patients with relapsed or refractory B-cell lymphoproliferative disorders. CAR-T cell therapy is an advanced immunotherapy that modifies a patient's T cells to target the CD19 antigen on B cells. This follow-up study focuses on assessing the durability of treatment responses and monitoring potential late-onset adverse events in patients who previously received anti-CD19 CAR-T cells during the HemC101-01-01 trial (NCT06705530).

The primary objective of this study is to evaluate the long-term safety profile of second-generation anti-CD19 CAR-T cells, including the incidence, duration, and severity of adverse events. Secondary objectives include assessing the durability of clinical responses, such as overall response rate (ORR), progression-free survival (PFS), duration of response (DoR), and overall survival (OS). Additionally, the study aims to monitor the persistence and expansion of CAR-T cells in peripheral blood and detect the development of anti-drug antibodies (ADAs) that may impact therapeutic efficacy.

Eligible participants include adults aged 18-70 who completed the HemC101-01-01 trial and meet all inclusion criteria, such as sufficient organ function and negative pregnancy tests where applicable. This study involves periodic follow-up visits over 11 months post-CAR-T cell infusion, during which clinical assessments, laboratory evaluations, and safety monitoring will be conducted. No additional CAR-T cell infusions will be administered in this follow-up study.

The trial is conducted at a single clinical center in Russia under the sponsorship of the National Medical Research Center of Hematology, Ministry of Health of Russia. The data collected will provide insights into the long-term safety and efficacy of anti-CD19 CAR-T therapy, contributing to the development of treatment protocols and improving outcomes for patients with relapsed or refractory B-cell malignancies.

Conditions

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

Keywords

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CAR-T B-cell lymphoma non-Hodgkin lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hem101 Arm

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Uncontrolled life-threatening infection. A urinary tract infection is acceptable. Patients who received intravenous antibiotics before IMP administration or in whom intravenous antibiotics have not been discontinued 7 days before inclusion in the study. Prophylactic use of antibiotics, antiviral, or antifungal drugs is allowed.
2. 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).
3. 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.
4. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Medical Research Center for Hematology

Moscow, , Russia

Site Status

Countries

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Russia

Central Contacts

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Clinical Trial Information Processing Team

Role: CONTACT

Phone: +74956124551

Email: [email protected]

Other Identifiers

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HemC101-01-02

Identifier Type: -

Identifier Source: org_study_id