Hematological MalignancyPhase 2/3NCT06238336
Clinical Study of CAR-T Technology for the Treatment of Relapsed Refractory Malignant Haematological Tumours
A Phase 2/3 study testing CAR-T cell therapy in people with Hematological Malignancy, run by Shanxi Bethune Hospital at 1 site in China.
Trial summary
The trial is designed as an early exploratory single-centre, open, single-arm clinical trial. The trial is planned to evaluate the safety and efficacy of CAR-T for the treatment of relapsed refractory malignant haematological tumours. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Hematological Malignancy
- What is being tested?
- CAR-T cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2020to 20 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients or their legal guardians voluntarily participate and sign an informed consent form;
- male or female patients aged 14 to 70 years (inclusive);
- be diagnosed as malignant haematological tumour by pathological and histological examination;
- have a measurable or evaluable lesion;
- the patient has good function of major tissues and organs:
- Liver function: ALT/AST <3 times upper limit of normal (ULN) and total bilirubin ≤34.2 μmol/L; (2) Renal function: creatinine <220 μmol/L; (3) Lung function: room oxygen saturation ≥95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. (6) Patient's peripheral superficial venous blood flow is smooth and can meet the demand of intravenous drip; 7. patients with ECOG score ≤2 and expected survival time ≥3 months.
Who cannot join
- Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding;
- men or women who are planning to conceive within the last 1 year;
- patients who cannot guarantee effective contraception (condoms or birth control pills, etc.) within 1 year of enrolment;
- patients with uncontrolled infections within 4 weeks prior to enrolment;
- active viral hepatitis B/C;
- patients with HIV infection;
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- patients with severe autoimmune diseases or immunodeficiency diseases;
- patients who are allergic to large molecule biopharmaceuticals such as antibodies or cytokines;
- patients who have participated in other clinical trials within 6 weeks prior to enrolment;
- the patient has used hormones systematically within 4 weeks prior to enrolment (except for patients using inhaled hormones);
- the patient has a psychiatric disorder
- the patient has substance abuse/addiction;
- other conditions that, in the judgement of the investigator, make the patient unsuitable for enrolment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ShanxiBethuneH
Taiyuan, Shanxi, 030032
Liangming Ma, 13513629908, maliangming620928@163.com
About this study
The trial is designed as an early exploratory single-centre, open, single-arm clinical trial. The trial is planned to evaluate the safety and efficacy of CAR-T for the treatment of relapsed refractory malignant haematological tumours. The trial is divided into five visit periods as follows: screening period, non-myeloablative pretreatment, short-term follow-up period, mid-term follow-up period and exit visit.
Read the detailed description
- Screening period (-21 to -7 days, 2 weeks): subjects signed the informed consent form and completed a series of examinations, and it was judged by the investigator whether subjects met the inclusion criteria and did not meet the exclusion criteria based on the results of the examinations and the inclusion/exclusion criteria. And the investigator will judge whether some of the examination results within one month before the date of informed consent are acceptable according to the patient's condition.
- Non-myeloablative preconditioning (-4 to -1 days for 4 days): the need for preconditioning and the preconditioning regimen were decided based on the subject's condition, and the most commonly used regimen was the FC regimen. After returning to the study centre for admission at the time notified by the investigator, subjects received fludarabine and cyclophosphamide on days -4 to -2 of the trial; the drugs were discontinued for 1 day on day -1 and a series of tests were completed as baseline information for subjects after non-clear myeloid preconditioning;
- Short-term follow-up period (visits 4 to 10: 0 to 180 days over a period of 6 months): subjects return to the study centre for a series of examinations every month for 6 months following the start of infusing back the expected dose of CAR-T cells on Day 0 of the trial. The investigator evaluates the short-term safety and efficacy of CAR-T therapy based on the subjects' examination results;
- Medium- to long-term follow-up period (180 to 360 days over a period of 6 months): subjects will return to the research centre every 2 months for a series of examinations within 6 months after completion of the short-term follow-up. The investigators will evaluate the mid- and long-term safety and efficacy of CAR-T therapy based on the subjects' examination results;
- Withdrawal Visit (at any time): all subjects may withdraw from this study at any stage of the trial, with or without providing a reason. If the subject withdraws from the study after the return of the CAR-T cells, he/she will be required to complete the examination items required for the withdrawal visit in the visit flowchart; if the subject withdraws from the visit prior to the return of the CAR-T cells, he/she will be required to complete the safety examination items only, and the reason for the subject's withdrawal will be recorded in detail by the investigator. If the subject stops treatment due to AE, the investigator will follow the subject for necessary safety visits until the subject's AE returns to baseline levels or reaches steady state.
- Conditions
- Hematological Malignancy
- Being tested
- CAR-T cell therapy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cell therapyDrug
The application of CAR-T therapy in the clinic generally involves the in vitro preparation and in vivo infusion of CAR-T, and the specific experimental process is divided into five steps: (1) isolation of T cells from the peripheral blood of the cancer subjects or single harvested single nucleated cells; (2) use of genetic engineering to transfer CAR structural genes that can specifically recognise the tumour cells into the T cells; (3) in vitro cultivation and expansion of CAR-T cells to the desired infusion dose (4) Non-myeloablative chemotherapy is administered prior to the infusion of CAR-T cells, which is used to remove immunosuppressive cells and reduce the tumour load so as to enhance the efficacy of the treatment; (5) CAR-T cells are infused according to the expected dosage, and the efficacy of the treatment is observed and the adverse reactions are closely monitored.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cell therapy | Experimental | Dose climbing started with 1.0*10^6/kg back infusion, 3 patients per dose group, if there is no adverse reaction the dose can be increased to 2.0*10^6/kg, 4.0*10^6/kg, the maximum dose can be extended the study. Receives: Drug: CAR-T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events
Adverse events associated with CAR-T therapy, serious adverse events and clinically significant laboratory test abnormalities.
Measured: Up to 36 months
Secondary outcomes (6)
CAR-T amplification levels
Characterisation of CAR-T cell expansion levels in subjects (peripheral blood, bone marrow, cerebrospinal fluid and lymph nodes, etc.) over time.
Measured: Up to 36 months
Duration of the CAR-T
Duration of CAR-T cell persistence in subjects (peripheral blood, bone marrow, cerebrospinal fluid and lymph nodes, etc.
Measured: Up to 36 months
Lymphocyte abatement
The characteristics of lymphocyte ablation in the subject.
Measured: Up to 36 months
Objective Response Rate (ORR)
Proportion of patients whose tumour volume shrinks to a pre-specified value and who are able to maintain the minimum timeframe required, as the sum of the proportions in complete and partial remission. Objective tumour remission rates at 3 months, 6 months and 1 year follow-up after treatment.It is the sum of the proportions of complete remission (CR) and partial remission (PR).
Measured: Up to 6 months
Progression-free survival(PFS)
Time from start of patient's treatment to disease progression or death from any cause
Measured: Up to 36 months
Event free survival (EFS)
Time from the start of enrolment to the occurrence of any event.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start15 Jun 2020
- Primary completion15 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaomin Zhang, Principal investigator, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238336
- Sponsor's protocol ID
- YXLL-2019-114
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CAR-T Technology for the Treatment of Relapsed Refractory Malignant Haematological Tumours
- ClinicalTrials.gov ID
- NCT06238336
- Acronym / sponsor ID
- YXLL-2019-114
- Conditions
- Hematological Malignancy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 2 Feb 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.
The trial is designed as an early exploratory single-centre, open, single-arm clinical trial. The trial is planned to evaluate the safety and efficacy of CAR-T for the treatment of relapsed refractory malignant haematological tumours. The trial is divided into five visit periods as follows: screening period, non-myeloablative pretreatment, short-term follow-up period, mid-term follow-up period and exit visit.
Detailed description
- Screening period (-21 to -7 days, 2 weeks): subjects signed the informed consent form and completed a series of examinations, and it was judged by the investigator whether subjects met the inclusion criteria and did not meet the exclusion criteria based on the results of the examinations and the inclusion/exclusion criteria. And the investigator will judge whether some of the examination results within one month before the date of informed consent are acceptable according to the patient's condition.
- Non-myeloablative preconditioning (-4 to -1 days for 4 days): the need for preconditioning and the preconditioning regimen were decided based on the subject's condition, and the most commonly used regimen was the FC regimen. After returning to the study centre for admission at the time notified by the investigator, subjects received fludarabine and cyclophosphamide on days -4 to -2 of the trial; the drugs were discontinued for 1 day on day -1 and a series of tests were completed as baseline information for subjects after non-clear myeloid preconditioning;
- Short-term follow-up period (visits 4 to 10: 0 to 180 days over a period of 6 months): subjects return to the study centre for a series of examinations every month for 6 months following the start of infusing back the expected dose of CAR-T cells on Day 0 of the trial. The investigator evaluates the short-term safety and efficacy of CAR-T therapy based on the subjects' examination results;
- Medium- to long-term follow-up period (180 to 360 days over a period of 6 months): subjects will return to the research centre every 2 months for a series of examinations within 6 months after completion of the short-term follow-up. The investigators will evaluate the mid- and long-term safety and efficacy of CAR-T therapy based on the subjects' examination results;
- Withdrawal Visit (at any time): all subjects may withdraw from this study at any stage of the trial, with or without providing a reason. If the subject withdraws from the study after the return of the CAR-T cells, he/she will be required to complete the examination items required for the withdrawal visit in the visit flowchart; if the subject withdraws from the visit prior to the return of the CAR-T cells, he/she will be required to complete the safety examination items only, and the reason for the subject's withdrawal will be recorded in detail by the investigator. If the subject stops treatment due to AE, the investigator will follow the subject for necessary safety visits until the subject's AE returns to baseline levels or reaches steady state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T cell therapy | Experimental | Drug: CAR-T cell therapyDose climbing started with 1.0*10^6/kg back infusion, 3 patients per dose group, if there is no adverse reaction the dose can be increased to 2.0*10^6/kg, 4.0*10^6/kg, the maximum dose can be extended the study. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- patients or their legal guardians voluntarily participate and sign an informed consent form;
- male or female patients aged 14 to 70 years (inclusive);
- be diagnosed as malignant haematological tumour by pathological and histological examination;
- have a measurable or evaluable lesion;
- the patient has good function of major tissues and organs:
Key exclusion criteria (13 listed)
- Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding;
- men or women who are planning to conceive within the last 1 year;
- patients who cannot guarantee effective contraception (condoms or birth control pills, etc.) within 1 year of enrolment;
- patients with uncontrolled infections within 4 weeks prior to enrolment;
- active viral hepatitis B/C;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-T cell therapyThe application of CAR-T therapy in the clinic generally involves the in vitro preparation and in vivo infusion of CAR-T, and the specific experimental process is divided into five steps: (1) isolation of T cells from the peripheral blood of the cancer subjects or single harvested single nucleated cells; (2) use of genetic engineering to transfer CAR structural genes that can specifically recognise the tumour cells into the T cells; (3) in vitro cultivation and expansion of CAR-T cells to the desired infusion dose (4) Non-myeloablative chemotherapy is administered prior to the infusion of CAR-T cells, which is used to remove immunosuppressive cells and reduce the tumour load so as to enhance the efficacy of the treatment; (5) CAR-T cells are infused according to the expected dosage, and the efficacy of the treatment is observed and the adverse reactions are closely monitored. | Drug | CAR-T cell therapy |
Primary outcome
Incidence of treatment-related adverse events
Time frame: Up to 36 months
Adverse events associated with CAR-T therapy, serious adverse events and clinically significant laboratory test abnormalities.
6 secondary outcomes
CAR-T amplification levels
Time frame: Up to 36 months
Duration of the CAR-T
Time frame: Up to 36 months
Lymphocyte abatement
Time frame: Up to 36 months
Objective Response Rate (ORR)
Time frame: Up to 6 months
Progression-free survival(PFS)
Time frame: Up to 36 months
Event free survival (EFS)
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- 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. This study is not recruiting at the moment.
Xiaomin Zhang principal investigator
Shanxi Bethune Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CAR-T cell therapy in people with Hematological Malignancy, run by Shanxi Bethune Hospital at 1 site in China.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 2 Feb 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 China. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liangming Ma (13513629908, maliangming620928@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events (time frame: Up to 36 months). 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 2 Feb 2024.