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RecruitingNCT02259556CART30Updated Jan 28, 2016

CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

A Phase 1/2 interventional study of CART30 in Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by Chinese PLA General Hospital · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2018, 8 years ago, but the record still lists the study as recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
16 Years to 80 Years
Sex
All
01

Study summary

Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).

Read the detailed description

When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.

Extra blood will be drawn to measure the persistence of CART30 in vivo.

02

Conditions studied

  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
03

In context

Hodgkin Disease

914 studies on the registry are indexed under Hodgkin Disease; 136 are open to participants now.

This study's planned enrollment of 30 is below the median of 43 across 746 interventional studies indexed under Hodgkin Disease.

Browse Hodgkin Disease studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 568 studies on the registry; 205 are open to participants now.

Browse Chinese PLA General Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 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

  • Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.
  • Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.
  • Karnofsky or Lansky score greater than 60%.
  • Expected survival>12 weeks.
  • Creatinine\<2.5mg/dl.
  • ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 fold normal.
  • Bilirubin\<2.5mg/dl.
  • Pulse oximetry of >90% on room air.
  • Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.
  • Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.
  • Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.

Exclusion criteria

Exclusion Criteria:

  • Active infection such as hepatitis B or C.
  • Receive anti-CD30 antibody-based therapy within recent 6 weeks.
  • Current use of systemic corticosteroids.
  • Pregnant or lactating.
  • Confirmed tumor in pulmonary and archenteric tissues.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    anti-CD30 CAR T cells

    Patients receive CART30 cell infusions with an escalation dose.

    Biological: CART30

Interventions

  • BiologicalCART30

    Cells will be infused 1 day after the completion of conditioning regimen.

    Also known as: anti-CD30 CAR T cells

06

What researchers measure

Primary outcomes

  1. Occurrence of related adverse events

    Time frame: untill week 24

Secondary outcomes

  1. Anti-tumor response to CART30 cell infusions

    Evaluated mainly by computed tomography scanning

    Time frame: Up to 24 weeks

Other outcomes

  1. in vivo existence of CART30

    Measure mainly by the changes of CAR molecule levels in blood

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing Municipality 100853, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Oct 2018 and a completion of Oct 2029. It does not say whether these dates are actual or estimated.

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

Registered
Oct 5, 2014
First posted
Oct 8, 2014
Start
Oct 2014
Primary completionEst.
Oct 2018
CompletionEst.
Oct 2029
Last update
Jan 28, 2016
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 Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02259556
Lead sponsor
Chinese PLA General Hospital
Responsible party
Han weidong (Director, Chinese PLA General Hospital) — Principal investigator
First posted
Oct 8, 2014
Start date
Oct 2014
Primary completion
Oct 2018 (estimated)
Completion
Oct 2029 (estimated)
Last update
Jan 28, 2016

Study contacts

Weidong Han, Ph.D
Contact
hanwdrsw@sina.com
86-10-66937463
Quanshun Wang, Ph.D
Contact
wqs63@sohu.com
86-10-66939486
Weidong Han, Ph.D
study chair · Chinese PLA General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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