Refractory and Relapsed T Cell LymphomaPhase 2NCT05059912
CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma
A Phase 2 study testing Humanized CD7 CAR-T cells in people with Refractory and Relapsed T Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is a prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory and Relapsed T Cell Lymphoma
- What is being tested?
- Humanized CD7 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2021to 3 Aug 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry
- The expressions of both CD4 and CD8 are negative in patients with bone marrow involved
- The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
- The main organ functions need to meet the following conditions:
- A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2.5 upper limitation of normal D.T-BIL≤2.0mg/dl E.SpO2 > 90%
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- Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
- Expected survival exceeds 3 months
- Written informed consent could be acquired
Who cannot join
- Immunosuppressant medications or steroids were used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
- Patients with uncontrolled active infection
- Active hepatitis B or hepatitis C infection
- Patients with HIV infection
- Severe acute or chronic graft-versus-host disease (GVHD)
- Participated in any other drug research clinical trials within 30 days before enrollment
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- Prior CAR-T cells therapy within 3 months before enrollment
- Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment
- Uncontrolled other tumor
- Women in pregnancy, lactation or planning to become pregnant
- The researcher considers inappropriate to participate in this research
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Depei Wu
About this study
Official title: Humanized CD7 CAR T-cell Therapy for R/R CD7+ T Cell Lymphoma
This is a prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma.
- Conditions
- Refractory and Relapsed T Cell Lymphoma
- Being tested
- Humanized CD7 CAR-T cells
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humanized CD7 CAR-T cellsBiological
Patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory T cell lymphoma
| Study group | Role | What they receive |
|---|---|---|
| CD7 positive relapsed or refractory T cell lymphoma | Experimental | Humanized CD7 CAR-T cells intravenously infused to patient with R/R T-NHL[ at a dose of (0.5- 5)x10^6 CD7 CAR-T cells/kg Receives: Biological: Humanized CD7 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Number of patients who achieved response (complete response and partial response ) after treatment of CD7 CAR-T cell. Response will be assessed using the Lugano criteria.
Measured: 1 year
Number of Adverse Events
Adverse events are evaluated with CTCAE V5.0
Measured: 1 year
Secondary outcomes (4)
Complete relapse rate(CR)
Number of patients who achieved complete response after treatment by CD7 CAR-T cell.
Measured: 1 year
Duration of overall response (DOR)
Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Measured: 1 year
Progression-free survival(PFS)
PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Measured: 1 year
Overall survival(OS)
OS will be assessed from the CAR-T cell infusion to death or last follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start5 Aug 2021
- Primary completion3 Aug 2023 (estimated)
- Study completion3 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory and Relapsed 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- PersonGen BioTherapeutics (Suzhou) Co., Ltd., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Jiangnan University, Affiliated Zhongshan Hospital of Dalian University, The First Affiliated Hospital of Dalian Medical University
- Responsible party
- Sponsor
- Investigators
- Depei Wu, M.D&Ph.D, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059912
- Sponsor's protocol ID
- CD7T
- Status last verified
- Aug 2021
- First submitted
- 17 Sep 2021
- Last updated
- 28 Sep 2021
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humanized CD7 CAR T-cell Therapy for R/R CD7+ T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05059912
- Acronym / sponsor ID
- CD7T
- Conditions
- Refractory and Relapsed T Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- PersonGen BioTherapeutics (Suzhou) Co., Ltd., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Jiangnan University, Affiliated Zhongshan Hospital of Dalian University, The First Affiliated Hospital of Dalian Medical University
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 3 Aug 2023 (estimated)
- Study completion
- 3 Aug 2024 (estimated)
- First posted
- 28 Sep 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 prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD7 positive relapsed or refractory T cell lymphoma | Experimental | Biological: Humanized CD7 CAR-T cellsHumanized CD7 CAR-T cells intravenously infused to patient with R/R T-NHL[ at a dose of (0.5- 5)x10^6 CD7 CAR-T cells/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry
- The expressions of both CD4 and CD8 are negative in patients with bone marrow involved
- The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
- The main organ functions need to meet the following conditions:
Key exclusion criteria (11 listed)
- Immunosuppressant medications or steroids were used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
- Patients with uncontrolled active infection
- Active hepatitis B or hepatitis C infection
- Patients with HIV infection
- Severe acute or chronic graft-versus-host disease (GVHD)
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 |
|---|---|---|
| Humanized CD7 CAR-T cellsPatients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory T cell lymphoma | Biological | CD7 positive relapsed or refractory T cell lymphoma |
Primary outcome
Overall response rate (ORR)
Time frame: 1 year
Number of patients who achieved response (complete response and partial response ) after treatment of CD7 CAR-T cell. Response will be assessed using the Lugano criteria.
Number of Adverse Events
Time frame: 1 year
Adverse events are evaluated with CTCAE V5.0
4 secondary outcomes
Complete relapse rate(CR)
Time frame: 1 year
Duration of overall response (DOR)
Time frame: 1 year
Progression-free survival(PFS)
Time frame: 1 year
Overall survival(OS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- 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.
Depei Wu, M.D&Ph.D study chair
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Humanized CD7 CAR-T cells in people with Refractory and Relapsed T Cell Lymphoma, run by The First Affiliated Hospital of Soochow 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 9 inclusion and 11 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 28 Sep 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Caixia Li, M.D (+86 512 67781856, licaixia@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 1 year). 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 28 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.