T Cell Lymphoblastic LymphomaPhase 1NCT05554575
Chimeric Antigen Receptor T-Cell (CAR-T) Cells in Patients With R/R T-LBL
A Phase 1 study testing BT-007 CD7 CAR-T cells in people with T Cell Lymphoblastic Lymphoma, run by Bioceltech Therapeutics, Ltd. at 1 site in China.
Trial summary
This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of T cells expressing CD7 chimeric antigen receptors (referred to as "BT-007 CAR-T cells") in patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- T Cell Lymphoblastic Lymphoma
- What is being tested?
- BT-007 CD7 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Oct 2022to Sep 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CD7 positive T-cell lymphoma confirmed by histology;
- Relapsed refractory patients who received at least one line of systemic chemotherapy in the past;
- At least one measurable target lesion;
- Age: 18-70 years old (including 18 and 70 years old);
- The expected survival period is more than 3 months;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
Show all 11Show fewer
- Important organ functions met: left ventricular ejection fraction≥50% according to cardiac ultrasound; Serum Cr≤1.25 times the upper limit of normal range (ULN) or endogenous creatinine clearance≥45mL/min (Cockcroft Gault formula); ALT and AST≤3 times ULN, TBIL≤1.5 times ULN;
- Blood routine: hemoglobin (Hgb)≥80g/L, neutrophil count (ANC)≥1×10^9/L, platelet PLT≥50×10^9/L；
- Coagulation function: International standardized ratio (INR)≤1.5 times ULN; Activated partial thromboplastin time (APTT)≤1.5 times ULN (unless the subject is receiving anticoagulant treatment, and prothrombin time (PT)/INR and APTT are within the expected range of anticoagulant treatment at the time of screening);
- The pregnancy test of women of childbearing age must be negative; Both male and female patients need to agree to use effective contraceptive measures during the treatment period and within the following 1 year;
- Participate in this test voluntarily and sign the informed consent.
Who cannot join
- Used immunosuppressive agents or therapeutic doses of corticosteroids (defined as prednisone>20mg or equivalent dose) within one week before blood collection, or used drugs that stimulate bone marrow hematopoiesis, such as Human Granulocyte Colony Stimulating Factor (G-CSF); But physiological substitution, topical or inhaled steroids are permitted;
- Uncontrolled systemic active fungi, bacteria, viruses or other infections;
- Active hepatitis B (HBV DNA>500IU/mL), hepatitis C (HCV RNA positive) or human immunodeficiency virus (HIV) antibody positive;
- Central nervous system invasion, or central nervous system disease history, such as epilepsy, cerebrovascular disease, etc;
- Pregnant or lactating women, or patients do not agree to use effective contraceptives during treatment and within the following 1 year;
- Receiving allogeneic hematopoietic stem cell transplantation or organ transplantation;
Show all 10Show fewer
- Previous history of other malignant tumors. Patients with cured skin basal or squamous cell carcinoma and cervical carcinoma in situ at any time before the study were not included; Patients with other tumors not listed above, but which have been cured by surgery but not by other further treatment measures, and disease-free survival≥5 years, can be included in the study;
- Patients with primary immunodeficiency or autoimmune diseases, but asymptomatic hypothyroidism, or well controlled type I diabetes can participate in this study;
- Patients who participated in other clinical trials within 4 weeks before blood collection;
- The investigator considers that there are other factors that are not suitable for inclusion or affect the subjects to participate in or complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
+0086-10-88121122
About this study
Official title: Safety and Efficacy of BT-007 CAR-T Cells in the Treatment of Patients With Relapsed/Refractory T Cell Lymphoblastic Lymphoma (R/R T-LBL)
This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of T cells expressing CD7 chimeric antigen receptors (referred to as "BT-007 CAR-T cells") in patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL).
Read the detailed description
Primary objective:
To investigate the safety and efficacy of CD7 CAR-T cells in the treatment of patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL).
Secondary objective:
To assess the patient's quality of life after receiving the treatment.
- Conditions
- T Cell Lymphoblastic Lymphoma
- Being tested
- BT-007 CD7 CAR-T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT-007 CD7 CAR-T cellsBiological
T cells purified from the peripheral blood mononuclear cell (PBMC) of subjects or subjects' relatives which depend on their conditions, transduced with 4-1BB/CD3ζ lentiviral vector, expanded in vitro for future administration.
| Study group | Role | What they receive |
|---|---|---|
| BT-007 CD7 CAR-T cells in R/R T-LBL | Experimental | Subjects will receive BT-007 CD7 CAR-T cells infusion on Day 0 : 100% of total dose. Receives: Biological: BT-007 CD7 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The percentage of participants who achieved complete remission (CR) over all participants.
The tumor status of patient is assessed for the baseline when assigned into treatment group. The overall CR is assessed by the Lugano Classification Lymphoma Response Criteria 2014 on Day 28, Month 3, Month 6, as well as Month 24 for termination. The overall CR is also assessed for the case withdraw from treatment before the termination of 24 months.
The percentage of participants who achieved partial remission (PR) over all participants.
The assessment criteria and time frame are the same as CR.
Measured: The changes between baseline and Day 28, Month 3, Month 6, as well as Month 24 for termination.
Secondary outcomes (2)
The retention amount of CAR-T cells remaining in vivo
The retention amount of CAR-T cells in all subjects within 24 months when terminated.
The retention amount of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion. The retention amount is also assessed every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated.
Measured: The retention amount of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion, and every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated.
The retention time of CAR-T cells remaining in vivo
The retention time of CAR-T cells in all subjects within 24 months when terminated.
The retention time of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion. The retention time is also assessed every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated.
Measured: The retention time of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion, and every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Cell Lymphoblastic 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioceltech Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiping Liu, MD, PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554575
- Sponsor's protocol ID
- BT-LBL-007-v2
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of BT-007 CAR-T Cells in the Treatment of Patients With Relapsed/Refractory T Cell Lymphoblastic Lymphoma (R/R T-LBL)
- ClinicalTrials.gov ID
- NCT05554575
- Acronym / sponsor ID
- BT-LBL-007-v2
- Conditions
- T Cell Lymphoblastic Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bioceltech Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 26 Sep 2022 (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 single center, single arm, open-lable phase I study to determine the safety and efficacy of T cells expressing CD7 chimeric antigen receptors (referred to as "BT-007 CAR-T cells") in patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL).
Detailed description
Primary objective:
To investigate the safety and efficacy of CD7 CAR-T cells in the treatment of patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL).
Secondary objective:
To assess the patient's quality of life after receiving the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BT-007 CD7 CAR-T cells in R/R T-LBL | Experimental | Biological: BT-007 CD7 CAR-T cellsSubjects will receive BT-007 CD7 CAR-T cells infusion on Day 0 : 100% of total dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with CD7 positive T-cell lymphoma confirmed by histology;
- Relapsed refractory patients who received at least one line of systemic chemotherapy in the past;
- At least one measurable target lesion;
- Age: 18-70 years old (including 18 and 70 years old);
- The expected survival period is more than 3 months;
Key exclusion criteria (10 listed)
- Used immunosuppressive agents or therapeutic doses of corticosteroids (defined as prednisone>20mg or equivalent dose) within one week before blood collection, or used drugs that stimulate bone marrow hematopoiesis, such as Human Granulocyte Colony Stimulating Factor (G-CSF); But physiological substitution, topical or inhaled steroids are permitted;
- Uncontrolled systemic active fungi, bacteria, viruses or other infections;
- Active hepatitis B (HBV DNA>500IU/mL), hepatitis C (HCV RNA positive) or human immunodeficiency virus (HIV) antibody positive;
- Central nervous system invasion, or central nervous system disease history, such as epilepsy, cerebrovascular disease, etc;
- Pregnant or lactating women, or patients do not agree to use effective contraceptives during treatment and within the following 1 year;
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 |
|---|---|---|
| BT-007 CD7 CAR-T cellsT cells purified from the peripheral blood mononuclear cell (PBMC) of subjects or subjects' relatives which depend on their conditions, transduced with 4-1BB/CD3ζ lentiviral vector, expanded in vitro for future administration. | Biological | BT-007 CD7 CAR-T cells in R/R T-LBL |
Primary outcome
Objective response rate (ORR)
Time frame: The changes between baseline and Day 28, Month 3, Month 6, as well as Month 24 for termination.
The percentage of participants who achieved complete remission (CR) over all participants. The tumor status of patient is assessed for the baseline when assigned into treatment group. The overall CR is assessed by the Lugano Classification Lymphoma Response Criteria 2014 on Day 28, Month 3, Month 6, as well as Month 24 for termination. The overall CR is also assessed for the case withdraw from treatment before the termination of 24 months. The percentage of participants who achieved partial remission (PR) over all participants. The assessment criteria and time frame are the same as CR.
2 secondary outcomes
The retention amount of CAR-T cells remaining in vivo
Time frame: The retention amount of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion, and every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated.
The retention time of CAR-T cells remaining in vivo
Time frame: The retention time of CAR-T cells in all subjects is assessed on Day 1, 7, 14, 28 during first month after cell infusion, and every month during Month 2 and 6, and every three months during Month 6 and 24 when terminated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for T Cell Lymphoblastic Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
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.
Weiping Liu, MD, PhD principal investigator
Peking University Cancer Hospital & Institute
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 BT-007 CD7 CAR-T cells in people with T Cell Lymphoblastic Lymphoma, run by Bioceltech Therapeutics, Ltd. 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 11 inclusion and 10 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 26 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongwei Xu, MD, PhD (+0086-10-69739722, willyxu001@bioceltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: The changes between baseline and Day 28, Month 3, Month 6, as well as Month 24 for termination.). 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 26 Sep 2022.