ClinicalTrials.gg
RecruitingNCT03383965Updated Dec 27, 2017

CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

A Phase 1 interventional study of ICAR30 T cells in Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma, sponsored by Immune Cell, Inc.. Recruiting at 1 site in China. Open to participants aged 2 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-27.

Sponsored by Immune Cell, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2020, 5 years 10 months ago, but the record still lists the study as recruiting.
  • Registered 9 months after the study started (first participant enrolled Mar 2017, registered Dec 2017).
  • Started Mar 2017; still recruiting 9 years 8 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
2 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Hodgkin Disease with a site in China — 27 open to participants now, 30 under way, 3 of them phase 3. Hodgkin Disease · China.

Planned enrollment
47th of 53
20 · median 75
Started
2017
with 6 others
Phase 1
8 of 56
4 open now
Primary completion
2020-12
later than 1 of 29 live
Registered
11th of 56
by date

Among the 56 studies in Hodgkin Disease with a site in China, this one is the 47th largest by planned enrollment of the 53 interventional ones, is one of 7 that started in 2017, is one of 8 in phase 1, reaches primary completion later than 1 of the 29 other live ones, and was the 11th registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

Phase 226 · 13 open
Phase 1/210 · 5 open
Phase 1this study8 · 4 open
Phase 35 · 2 open
Observational3 · 1 open
Phase 2/32 · 1 open
No phase1 · 1 open
Phase 41 · 0 open

By the year they started

First in 2011; this study’s year is marked. 7 started in 2017.

Size and results

Median enrollment 75 across the 53 interventional studies, 2,000 across the 3 observational. Of the 11 that completed or were terminated, 5 (45%) have results posted.

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02

Study 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. 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.

03

Conditions studied

  • Hodgkin Lymphoma
  • Anaplastic Large Cell Lymphoma
04

Who can participate

Ages eligible
2 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive , :

  • or Lansky score >50;
  • Expected survival>12 weeks;
  • > 8.0;
  • , FVC and DLCO ≥50% of expected corrected for hemoglobin;
  • ≥50%;
  • Creatinine\<2.5mg/dl;
  • \<2.5mg/dl;
  • (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 fold normal;
  • Patients must sign an .

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating;
  • Uncontrolled active infection including or C;
  • positive;
  • Active CNS dysfunction;
  • Current use of systemic ;
  • Heterogenous lymphocyte treatments within recent 6 months;
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    ICAR30 T cells

    anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.

    Biological: ICAR30 T cells

Interventions

  • BiologicalICAR30 T cells

    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.

    Also known as: Biological drug

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 3 years

  2. 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.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2017 (actual). Primary completion is estimated for Dec 2020, 45 months after the start.

Of 91 phase 1 interventional studies under Hodgkin Disease, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 79. This study's planned 45 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2017
First posted
Dec 27, 2017
StartActual
Mar 1, 2017
Primary completionEst.
Dec 31, 2020
CompletionEst.
Dec 31, 2025
Last update
Dec 27, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03383965
Lead sponsor
Immune Cell, Inc.
Collaborators
Weifang People's Hospital
Responsible party
Xiulian Sun (Principal Investigator, Immune Cell, Inc.) — Principal investigator
First posted
Dec 27, 2017
Start date
Mar 1, 2017
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 27, 2017

Study contacts

Xiulian Sun, MD.,Ph.D
Contact
xiuliansun@ymcell.com
(+86) 010-62420689

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Biological Products

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