T Cell Lymphoma in RelapsePhase 1NCT04162340
CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies
A Phase 1 study testing CD4 CAR T cells in people with T Cell Lymphoma in Relapse and Refractory T-Cell Lymphoma, run by iCell Gene Therapeutics at 2 sites in China.
Trial summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T Cell Lymphoma in Relapse, Refractory T-Cell Lymphoma
- What is being tested?
- CD4 CAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 11 Jul 2019to Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent; Patients volunteer to participate in the research
- Diagnosis is mainly based on the World Health Organization (WHO) 2008
- Patients have exhausted standard therapeutic options
- Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
- Female must be not pregnant during the study
Who cannot join
- Patients declining to consent for treatment
- Prior solid organ transplantation
- Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- Any drug used for GVHD must be stopped >1 week
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Chengdu Military General Hospital
Chengdu, Sichuan
Fang Liu, MD/PhD, lfyh2006@yahoo.com
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Hongyu Zhang, MD/PhD, Hongyu.Zhang@pkuszh.com
About this study
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.
Read the detailed description
CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.
- Being tested
- CD4 CAR T cells
- Keywords
- CD4-specific CAR T, T cell leukemia, T cell lymphoma, CD4CAR
- 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.
CD4 CAR T cellsBiological
CD4 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CD4 CAR T cells | Experimental | Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg Receives: Biological: CD4 CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events after CD4 CAR T cells cell infusion
Determine the toxicity profile of CD4 CAR T cell therapy
Measured: 2 years particularly the first 28 days after infusion
Secondary outcomes (4)
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Measured: up to 6 months
Disease Free Survival (DFS)
Disease Free Survival (DFS) (IMWG criteria)
Measured: up to 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (IMWG criteria)
Measured: up to 2 years
Overall Survival (OS)
overall survival
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start11 Jul 2019
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Cell Lymphoma in RelapseStudies 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
- Sequential
- Model description
- Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iCell Gene Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital
- Responsible party
- Sponsor
- Investigators
- Hongyu Zhang, MD/PhD, Principal investigator, Peking University Shenzhen Hospital, ChinaFang Liu, MD/PhD, Principal investigator, Chengdu Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162340
- Sponsor's protocol ID
- ICG155-001
- Status last verified
- May 2021
- First submitted
- 11 Nov 2019
- Last updated
- 19 May 2021
- 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 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies
- ClinicalTrials.gov ID
- NCT04162340
- Acronym / sponsor ID
- ICG155-001
- Keywords
- CD4-specific CAR T, T cell leukemia, T cell lymphoma, CD4CAR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- iCell Gene TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 14 Nov 2019 (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 I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.
Detailed description
CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg
| Arm | Type | Receives |
|---|---|---|
| CD4 CAR T cells | Experimental | Biological: CD4 CAR T cellsDose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 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 (5 listed)
- Signed written informed consent; Patients volunteer to participate in the research
- Diagnosis is mainly based on the World Health Organization (WHO) 2008
- Patients have exhausted standard therapeutic options
- Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
- Female must be not pregnant during the study
Key exclusion criteria (4 listed)
- Patients declining to consent for treatment
- Prior solid organ transplantation
- Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- Any drug used for GVHD must be stopped >1 week
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 |
|---|---|---|
| CD4 CAR T cellsCD4 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy. | Biological | CD4 CAR T cells |
Primary outcome
Number of adverse events after CD4 CAR T cells cell infusion
Time frame: 2 years particularly the first 28 days after infusion
Determine the toxicity profile of CD4 CAR T cell therapy
4 secondary outcomes
Incidence of treatment-emergent adverse events
Time frame: up to 6 months
Disease Free Survival (DFS)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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.
Hongyu Zhang, MD/PhD principal investigator
Peking University Shenzhen Hospital, China
Fang Liu, MD/PhD principal investigator
Chengdu Military Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD4 CAR T cells in people with T Cell Lymphoma in Relapse and Refractory T-Cell Lymphoma, run by iCell Gene Therapeutics at 2 sites 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 5 inclusion and 4 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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Kevin Pinz, MS (6315386218, kevin.pinz@icellgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events after CD4 CAR T cells cell infusion (time frame: 2 years particularly the first 28 days after infusion). 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 19 May 2021.