Actively Recruiting
SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
Led by Chinese PLA General Hospital · Updated on 2023-06-15
100
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, phase I/II dose escalation and expansion trial. The primary objective of dose escalation phase I study is to evaluate the safety and feasibility of SHR1701 in patients with relapsed or refractory classical Hodgkin Lymphoma. The primary objective of open-label, randomized, phase II study is to assess the antitumor effect of SHR1701 alone or in combination with SHR2554 in patients with relapsed or refractory classical Hodgkin Lymphoma.
CONDITIONS
Official Title
SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation of relapsed or refractory Hodgkin lymphoma
- Age between 12 and 75 years
- ECOG performance status less than 2
- Life expectancy of at least 3 months
- At least one measurable lymphoma lesion larger than 1 cm
- Received two or more prior therapies and off therapy for at least 4 weeks
- Autologous hematopoietic stem-cell transplantation allowed if more than 3 months prior
- Prior treatment with anti-PD-1/PD-L1 or CTLA-4 inhibitors allowed if off therapy for at least 4 weeks
- Adequate bone marrow, liver, kidney, and heart function
You will not qualify if you...
- Autoimmune disease or history requiring corticosteroids or immunosuppressive medications
- Serious uncontrolled medical disorders or active infections, especially lung infections
- Active or recent alimentary tract hemorrhage within 1 month
- Prior organ transplantation
- Pregnant or breastfeeding women
- Positive pregnancy test at enrollment or before treatment
- Compulsory detention for psychiatric or physical illness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Han wei dong
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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