T Cell LymphomaPhase 1NCT04840875
Phase I Clinical Trial of Autologous CD7-CAR T Cell Therapy for High-risk Acute T-cell Leukemia/lymphoma
A Phase 1 study testing chimeric antigen receptor T cell treatment in people with T Cell Lymphoma and T-cell Leukemia, run by Beijing Boren Hospital at 1 site in China.
Trial summary
This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse… Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- T Cell Lymphoma, T-cell Leukemia
- What is being tested?
- chimeric antigen receptor T cell treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2021to 1 Sep 2023
- Phase
- Phase 1
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen CD7
- Refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks
- Male or female, aged 0-70 years
- No serious allergic constitution
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
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- Have life expectancy of at least 60 days based on investigator's judgement
- CD7 positive in bone marrow or peripheral blood or immunohistochemistry
- Candidates aged 8-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. And Pediatric patients under 8 years old could be recruited after signing an informed consent form by a legal surrogate (Guardian)
- Minimal residual disease was positive after chemotherapy and there were contraindications of allogeneic hematopoietic stem cell transplantation.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Intracranial hypertension or disorder of consciousness
- Symptomatic heart failure or severe arrhythmia
- Symptoms of severe respiratory failure
- Complicated with other types of malignant tumors
- Diffuse intravascular coagulation
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- Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
- Suffering from septicemia or other uncontrollable infections
- Patients with uncontrollable diabetes
- Severe mental disorders
- Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
- Have received organ transplantation (excluding hematopoietic stem cell transplantation);
- Reproductive-aged female patients with positive blood HCG test
- Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.
- Conditions
- T Cell Lymphoma, T-cell Leukemia
- Being tested
- chimeric antigen receptor T cell treatment
- Medical subject headings
- Lymphoma, T-Cell, Leukemia, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chimeric antigen receptor T cell treatmentBiological
Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.
| Study group | Role | What they receive |
|---|---|---|
| chimeric antigen receptor T cell treatment | Experimental | Not described Receives: Biological: chimeric antigen receptor T cell treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT rate
The DLT rate to the CAR-T treatment
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start14 Sep 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Cell LymphomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Boren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840875
- Sponsor's protocol ID
- BRYY-IIT-LCYJ-2021-004
- Status last verified
- Jun 2024
- First submitted
- 8 Apr 2021
- Last updated
- 14 Nov 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
- ClinicalTrials.gov ID
- NCT04840875
- Acronym / sponsor ID
- BRYY-IIT-LCYJ-2021-004
- Conditions
- T Cell Lymphoma, T-cell Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Beijing Boren HospitalUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 12 Apr 2021 (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 is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chimeric antigen receptor T cell treatment | Experimental | Biological: chimeric antigen receptor T cell treatment |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen CD7
- Refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks
- Male or female, aged 0-70 years
- No serious allergic constitution
Key exclusion criteria (14 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Intracranial hypertension or disorder of consciousness
- Symptomatic heart failure or severe arrhythmia
- Symptoms of severe respiratory failure
- Complicated with other types of malignant tumors
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 |
|---|---|---|
| chimeric antigen receptor T cell treatmentSubjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion. | Biological | chimeric antigen receptor T cell treatment |
Primary outcome
DLT rate
Time frame: 21 days
The DLT rate to the CAR-T treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing chimeric antigen receptor T cell treatment in people with T Cell Lymphoma and T-cell Leukemia, run by Beijing Boren 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 14 Nov 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT rate (time frame: 21 days). 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 14 Nov 2024.