QL1706 (bispecific antibody targeting PD-1 and CLTA-4)Pemetrexed (Alimta)
QL1706 (bispecific antibody targeting PD-1 and CLTA-4): Intrathecal injection of PD-1/CTLA-4 bispecific antibody was administered every 2 weeks for 6 weeks during the induction phase, followed by monthly injections during the maintenance phase, until recurrence or death.
Pemetrexed (Alimta): Pemetrexed (Alimta, Eli Lilly and Company) was administrated by intrathecal injection, first as induction therapy, twice per week for 2 weeks, followed by consolidation therapy, once per week for 4 weeks, then maintenance therapy, once per month until the patient's death, leptomeningeal metastasis progresses, or intolerable severe adverse events occurred.
Study summary
This phase I/II study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal dual checkpoint inhibitor (targeting PD-1 and CTLA-4 with QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.
Eligibility
Sex
ALL
Min age
21 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.
2. Male or female aged between 21 and 75 years; Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
3. No history of severe nervous system disease; No severe dyscrasia.
Exclusion Criteria:
1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.
4. Patients with poor compliance or other reasons that were unsuitable for this study.
Primary outcome measure(s)
RP2D — Dose limiting toxicity was assessed during the first 6 weeks after the first intrathecal administration. The recommended phase II dose. The dose limiting toxicity was defined as ≥ grade 3 neurological toxicities (e.g.,meningitis) or other grade 4 toxicity.
Incidence of treatment-related adverse events — From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. The incidence of treatment-related adverse events were measured for determining tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE). Events of grade 3-5 are defined as moderate and severe adverse events.
Trial sites (5)
Facility
City
Region
Status
Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine
Beijing
Beijing Municipality
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou
Guangdong
Huizhou First Hospital Affiliated to Guangdong Medical University
Huizhou
Guangdong
Beijing Chest Hospital, Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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