Actively Recruiting
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Led by Chinese PLA General Hospital · Updated on 2016-01-28
30
Participants Needed
1
Research Sites
574 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of chimeric antigen receptor-modified T cells (CART), specifically targeting CD30, for treating patients with relapsed or refractory CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma. This trial aims to assess how these CART30 cells work in patients who have not responded to prior treatments or who cannot complete standard chemotherapy. The study is conducted in phases 1 and 2 to explore safety and treatment effects in this patient group. In this trial, patients first undergo a conditioning regimen with cyclophosphamide and fludarabine while their autologous CART30 cells are prepared from their own blood. One day after completing this regimen, patients receive infusions of the CART30 cells intravenously over 3 to 5 consecutive days with escalating doses. This approach allows the researchers to monitor how different doses of CART30 cells behave and their potential effects. Participants will have extra blood samples taken to measure how long the CART30 cells persist in the body. The main outcomes include tracking any adverse events related to the treatment up to 24 weeks and evaluating the anti-tumor response over the same period. The study includes continued monitoring to assess safety and treatment impact, with participation lasting through this observation timeframe.
CONDITIONS
Brief Title
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects with CD30 positive Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation or refractory to two multidrug regimens and/or anti-CD30 antibody treatment
- Newly diagnosed CD30 positive Hodgkin lymphoma and Non-Hodgkin lymphoma patients unable to receive or complete standard chemotherapy
- Karnofsky or Lansky performance score greater than 60%
- Expected survival longer than 12 weeks
- Creatinine level less than 2.5 mg/dl
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than three times the normal level
- Bilirubin less than 2.5 mg/dl
- Pulse oximetry greater than 90% on room air
- Adequate lung function with FEV1, FVC, and DLCO at least 50% of expected corrected for hemoglobin
- Available autologous T cells with 10% or more expression of CD30 CAR by flow cytometry
- Patients or legal guardians must provide signed informed consent acknowledging awareness of study risks and benefits
You will not qualify if you...
- Active infection such as hepatitis B or hepatitis C
- Received anti-CD30 antibody therapy within the past 6 weeks
- Current use of systemic corticosteroids
- Pregnant or breastfeeding
- Confirmed tumors in pulmonary or gastrointestinal tissues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Time needed for cell preparation and conditioning regimen
Participants undergo collection of peripheral blood mononuclear cells to generate autologous CART30 cells and receive a conditioning regimen including cyclophosphamide and fludarabine.
Visits as needed during conditioning and cell preparation
Duration - 3 to 5 days
Participants receive escalating doses of CART30 cell infusions intravenously over 3 to 5 consecutive days starting one day after completing the conditioning regimen.
3 to 5 consecutive infusion visits (in-person)
Duration - Up to 24 weeks
Participants have extra blood drawn to measure persistence of CART30 cells and are monitored for adverse events and anti-tumor response up to 24 weeks after treatment.
Multiple visits across 24 weeks for monitoring and blood draws
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
W
Weidong Han, Ph.D
Q
Quanshun Wang, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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