Treatment for relapsed or refractory classical Hodgkin lymphoma using SHR1701 and SHR2554

An Open-Label Phase I/II Study of SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma

This study is testing a new treatment called SHR1701, alone and with another drug SHR2554, to see if it can help people with relapsed or refractory classical Hodgkin lymphoma.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05896046 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of SHR1701, both alone and in combination with SHR2554, for patients with relapsed or refractory classical Hodgkin lymphoma. The study is divided into two phases: a dose escalation phase I to determine the optimal dosage of SHR1701, followed by a phase II expansion to assess the antitumor effects of the treatment. Patients will receive SHR1701 intravenously at varying doses, and those in the phase II study will be randomized to receive either SHR1701 alone or in combination with SHR2554 based on the results from phase I.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 to 75 with histologically confirmed relapsed or refractory Hodgkin lymphoma who have received at least two prior therapies.

Not a fit: Patients with autoimmune diseases or those requiring immunosuppressive medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory classical Hodgkin lymphoma.

How similar studies have performed: While this approach is novel, similar studies targeting Hodgkin lymphoma have shown promising results with new therapies.

Eligibility criteria

Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
2. 12 to 75 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
6. Subjects must have received two or more lines of previous therapy, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Previous treatment with anti-PD-1/PD-L1 antibodies or cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors are allowed, and must be off therapy for at least 4 weeks.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Where this trial is running

Beijing, Beijing Municipality

• Han wei dong — Beijing, Beijing Municipality, China (RECRUITING)

Conditions: Relapsed or Refractory Hodgkin Lymphoma