Hodgkin LymphomaPhase 1NCT03383965
CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
A Phase 1 study testing ICAR30 T cells in people with Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma, run by Immune Cell, Inc. at 1 site in China.
Trial summary
CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma
- What is being tested?
- ICAR30 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
- 1 Mar 2017to 31 Dec 2025
- 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 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:
- Karnofsky or Lansky score >50;
- Expected survival>12 weeks;
- Hgb > 8.0;
- FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
- LVEF≥50%;
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- Creatinine<2.5mg/dl;
- Bilirubin<2.5mg/dl;
- ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal;
- Patients must sign an informed consent.
Who cannot join
- Pregnant or lactating;
- Uncontrolled active infection including hepatitis B or C;
- HIV positive;
- Active clinically significant CNS dysfunction;
- Current use of systemic steroids;
- Heterogenous lymphocyte treatments within recent 6 months;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Weifang People's Hospital
Weifang, Shandong, 261000
Xiulian Sun, M.D., Ph.D, (+86) 010-62420689, xiuliansun@ymcell.com
Xuehong Ran, Doctor, 0536-8192117, ranxuehong1967@163.com
About this study
Official title: A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.
- Conditions
- Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma
- Being tested
- ICAR30 T cells
- Medical subject headings
- Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICAR30 T cellsBiological
Also called Biological drug
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD30 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
| Study group | Role | What they receive |
|---|---|---|
| ICAR30 T cells | Experimental | anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion. Receives: Biological: ICAR30 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the safety of ICAR30 T cells
To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
Measured: 2 years
Secondary outcomes (2)
Measure the anti-tumor effect of ICAR30 T cells
To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
Measured: 3 years
Measure the survival time of ICAR30 T cells in vivo
To measure the survival time of ICAR30 T cells in vivo, extra blood will be drawn from patients receive ICAR30 T cells infusion in the follow-up time.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune Cell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Weifang People's Hospital
- Responsible party
- Principal investigator, Xiulian Sun, Immune Cell, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383965
- Sponsor's protocol ID
- CD30-targeting CAR-T
- Status last verified
- Mar 2017
- First submitted
- 6 Dec 2017
- Last updated
- 27 Dec 2017
- 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 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
- ClinicalTrials.gov ID
- NCT03383965
- Acronym / sponsor ID
- CD30-targeting CAR-T
- Conditions
- Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Immune Cell, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Weifang People's Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Dec 2017 (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.
CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICAR30 T cells | Experimental | Biological: ICAR30 T cellsanti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion. |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:
- Karnofsky or Lansky score >50;
- Expected survival>12 weeks;
- Hgb > 8.0;
- FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
Key exclusion criteria (6 listed)
- Pregnant or lactating;
- Uncontrolled active infection including hepatitis B or C;
- HIV positive;
- Active clinically significant CNS dysfunction;
- Current use of systemic steroids;
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 |
|---|---|---|
| ICAR30 T cellsAlso: Biological drugT cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD30 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage. | Biological | ICAR30 T cells |
Primary outcome
Measure the safety of ICAR30 T cells
Time frame: 2 years
To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
2 secondary outcomes
Measure the anti-tumor effect of ICAR30 T cells
Time frame: 3 years
Measure the survival time of ICAR30 T cells in vivo
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- 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.
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 ICAR30 T cells in people with Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma, run by Immune Cell, Inc. 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 6 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 27 Dec 2017. 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 Xiulian Sun, MD.,Ph.D ((+86) 010-62420689, xiuliansun@ymcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the safety of ICAR30 T cells (time frame: 2 years). 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 27 Dec 2017.