T-lymphoblastic LymphomaEarly Phase 1NCT06633341
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
A Early Phase 1 study testing CD5 CAR T-cells in people with T-lymphoblastic Lymphoma, run by Zhejiang University at 1 site in China.
Trial summary
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-lymphoma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- T-lymphoblastic Lymphoma
- What is being tested?
- CD5 CAR T-cells
- 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
- 20 Oct 2024to 20 Oct 2027
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. According to the 2016 WHO classification of lymphocyte tumors, histologically confirmed CD5-positive T-cell non-Hodgkin lymphoma (T-NHL),
- R/R T-NHL(meets one of the following conditions) :
- Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments;
- Primary drug resistance;
- Relapse after autologous hematopoietic stem cell transplantation;
- 2.CD5 expression rate was >90%;
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- 3. According to Lugano 2014, there should be at least one evaluable tumor lesion;
- 4. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
- 5. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
- 6. Refers to the pulse oxygen saturation 92% or higher oxygen (state);
- 7. Estimated life expectancy of minimum of 12 weeks;
- 8. ECOG 0-2;
- 9. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
- 10. Those who voluntarily participated in this trial and provided informed consent;
Who cannot join
- 1. History of epilepsy or other central nervous system disorders;
- 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- 3. Active infection of hepatitis B virus, C virus or hepatitis E virus;
- 4. Active infected persons who are not cured;
- 5. Before using any gene therapy products;
- 6. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:
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- treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone < 10 mg/d or an equivalent dose of the drug);
- received within 72 hours of small molecule targeted therapy;
- 2 weeks received systemic chemotherapy except (pretreatment);
- four weeks received radiotherapy;
- 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- 8. Any unsuitable to participate in this trial judged by the investigator;
- 9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
He Huang, PhD, 057187233772, hehuangyu@126.com
Yongxian Hu, PhD, 057187233772, huyongxian2000@aliyun.com
About this study
Official title: A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-lymphoma
Read the detailed description
In this study, 30 patients with relapsed refractory T-lymphoma were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-lymphoma; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-lymphoma were accumulated.
- Conditions
- T-lymphoblastic Lymphoma
- Being tested
- CD5 CAR T-cells
- Keywords
- CD5 CAR-T
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD5 CAR T-cellsBiological
Also called CD5+ T-lymphoma Targeted CAR T-cells injection
Each subject receive CD5+ T-lymphoma Targeted CAR T-cells by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Administration of CD5+ T-lymphoma Targeted CAR T-cells | Experimental | Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects. Receives: Biological: CD5 CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Up to 28 days after Treatment
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Measured: Up to 2 years after Treatment
Secondary outcomes (4)
Overall response rate ,ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Measured: Up to 12 weeks after CAR-T infusion
Duration of remission ,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Measured: Up to 1 years after CAR-T infusion
Progression Free Survival, PFS
The time from randomization or start of study treatment until objective tumor progression or death
Measured: Up to 2 years after Treatment
Overall survival, OS
The time from CAR-T infusion to death due to any cause
Measured: Up to 1 years after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-lymphoblastic LymphomaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633341
- Sponsor's protocol ID
- TXB2024013
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
- ClinicalTrials.gov ID
- NCT06633341
- Acronym / sponsor ID
- TXB2024013
- Conditions
- T-lymphoblastic Lymphoma
- Keywords
- CD5 CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 9 Oct 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.
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-lymphoma
Detailed description
In this study, 30 patients with relapsed refractory T-lymphoma were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-lymphoma; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-lymphoma were accumulated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of CD5+ T-lymphoma Targeted CAR T-cells | Experimental | Biological: CD5 CAR T-cellsDose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 1. According to the 2016 WHO classification of lymphocyte tumors, histologically confirmed CD5-positive T-cell non-Hodgkin lymphoma (T-NHL),
- Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments;
- Primary drug resistance;
- Relapse after autologous hematopoietic stem cell transplantation;
Key exclusion criteria (13 listed)
- 1. History of epilepsy or other central nervous system disorders;
- 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- 3. Active infection of hepatitis B virus, C virus or hepatitis E virus;
- 4. Active infected persons who are not cured;
- 5. Before using any gene therapy products;
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 |
|---|---|---|
| CD5 CAR T-cellsAlso: CD5+ T-lymphoma Targeted CAR T-cells injectionEach subject receive CD5+ T-lymphoma Targeted CAR T-cells by intravenous infusion | Biological | Administration of CD5+ T-lymphoma Targeted CAR T-cells |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Up to 28 days after Treatment
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years after Treatment
Incidence of treatment-emergent adverse events [Safety and Tolerability]
4 secondary outcomes
Overall response rate ,ORR
Time frame: Up to 12 weeks after CAR-T infusion
Duration of remission ,DOR
Time frame: Up to 1 years after CAR-T infusion
Progression Free Survival, PFS
Time frame: Up to 2 years after Treatment
Overall survival, OS
Time frame: Up to 1 years after CAR-T infusion
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 9 Oct 2024.
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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.
He Huang, MD principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD5 CAR T-cells in people with T-lymphoblastic Lymphoma, run by Zhejiang University 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 14 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: looking for participants now, as of the sponsor's last update on 9 Oct 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 He Huang, MD (057187233772, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Up to 28 days after Treatment). 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 9 Oct 2024.