CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age16-80
SponsorChinese PLA General Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
CART30
Biological/VaccineCells will be infused 1 day after the completion of conditioning regimen.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: anti-CD30 CAR T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of related adverse events
Time frame
untill week 24Secondary outcomes
1
Anti-tumor response to CART30 cell infusions
Evaluated mainly by computed tomography scanning
Time frame
Up to 24 weeksOther outcomes
1
in vivo existence of CART30
Measure mainly by the changes of CAR molecule levels in blood
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov