Non-Hodgkin Lymphoma, B-cellNCT06721598
An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative Disorders
An observational study of Non-Hodgkin Lymphoma, B-cell and Acute Lymphoblastic Leukemia ALL, run by National Research Center for Hematology, Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Non-Hodgkin Lymphoma, B-cell, Acute Lymphoblastic Leukemia ALL
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jan 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received the IMP in the HemC101-01-01 study and completed it per protocol
Who may be able to join
- Successful completion of the HemC101-01-01 study procedures.
- Negative pregnancy test for women of reproductive potential.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Non-interventional, Single-group Follow-up Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Adult Patients with Relapsed or Refractory Forms of B-cell Lymphoproliferative Disorders
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.
Read the detailed description
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.
- Keywords
- CAR-T, B-cell lymphoma, non-Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hem101 Arm | Subjects received Hem101 in Study Hem101-01-01 will be followed for 11 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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)
Measured: 11 month starting on the 29th day after IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start9 Jan 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma, B-cellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721598
- Sponsor's protocol ID
- HemC101-01-02
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-interventional, Single-group Follow-up Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Adult Patients with Relapsed or Refractory Forms of B-cell Lymphoproliferative Disorders
- ClinicalTrials.gov ID
- NCT06721598
- Acronym / sponsor ID
- HemC101-01-02
- Keywords
- CAR-T, B-cell lymphoma, non-Hodgkin lymphoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Study start
- 9 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hem101 Arm | – | –Subjects received Hem101 in Study Hem101-01-01 will be followed for 11 month |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received the IMP in the HemC101-01-01 study and completed it per protocol
Key inclusion criteria (2 listed)
- Successful completion of the HemC101-01-01 study procedures.
- Negative pregnancy test for women of reproductive potential.
Key exclusion criteria (4 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 11 month starting on the 29th day after IMP administration
Frequency of any adverse events (AEs) reported during the study period and AE characterization (severity, seriousness, etc.)
ORR [Efficacy]
Time frame: 11 month starting on the 29th day after IMP administration
Overall response rate (ORR) defined as the proportion of subjects with complete response (CR) or partial response (PR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Offical approval of the trial by the Ministry of Health of the Russian FederationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin Lymphoma, B-cell and Acute Lymphoblastic Leukemia ALL, run by National Research Center for Hematology, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Information Processing Team (+74956124551, clinicaltrials@bk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Incidence of Treatment-Emergent Adverse Events [Safety] (time frame: 11 month starting on the 29th day after IMP administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.