Actively Recruiting
An Investigator-initiated Trial to Evaluate the Efficacy and Safety of CAR-T Cells Therapy in the Treatment of Chronic or Refractory Primary Immune Thrombocytopenia (ITP)
Led by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Updated on 2024-07-22
10
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CAR-T cell therapy for patients with chronic or refractory primary Immune Thrombocytopenia (ITP), a condition where the immune system attacks platelets. This open-label, single-arm clinical trial aims to provide new treatment options for those who have not responded well to standard therapies. The study is being conducted at a single center and sponsored by the 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China. After patients join the study, their immune cells are collected through a procedure called leukapheresis to create CAR-T cells. Before receiving these modified cells by intravenous infusion, participants undergo a 3-5 day lymphodepletion treatment with fludarabine and cyclophosphamide to prepare their bodies. Following the infusion, patients are monitored closely for up to 12 weeks to evaluate safety and treatment response. Those showing lasting remission after 12 weeks will be followed for at least one year to assess long-term disease control. During the trial, participants will have regular assessments including physical exams, laboratory tests, and monitoring for adverse effects. The main outcome measured is the portion of patients who respond to treatment at least two weeks after infusion. Other outcomes include complete response rates, relapse rates, and duration of response. Safety events are tracked for up to 12 months. Overall participation may last over a year depending on individual response and follow-up needs.
CONDITIONS
Brief Title
Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to complete informed consent and comply with study procedures and visits
- Men and women aged 8 to 75 years
- Diagnosed with chronic (>12 months) or refractory primary Immune Thrombocytopenia
- No other diseases causing low platelets besides ITP
- Platelet count below 30 x 10⁹/L
- Stable corticosteroid treatment for at least 2 weeks if applicable
- Physical and laboratory tests within normal limits or clinically insignificant deviations
- Willingness to use effective contraception throughout the study period
You will not qualify if you...
- Diseases causing secondary immune thrombocytopenia
- Previous preventive splenectomy
- Hemostatic disorders other than chronic thrombocytopenia
- Use of drugs affecting platelet function or anticoagulants for more than 3 consecutive days within 2 weeks before and during the study
- History of platelet agglutination preventing reliable platelet count measurement
- Current or past malignant disease treated with chemotherapy or radiotherapy
- Severe heart conditions or events within one year before enrollment
- History or risk factors for thrombosis
- Acute or worsening chronic gastrointestinal diseases with bleeding risk, acute infections, or respiratory diseases
- Significant liver or kidney impairment
- Other decompensated diseases affecting study results
- Positive tests for HIV, hepatitis B or C, or other serious infections
- Severe allergies
- Pregnancy or breastfeeding
- History of mental illness or substance addiction
- Poor compliance or inability to follow study protocol
- Participation in other clinical trials within 4 weeks prior to this trial
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 week
Participants receive lymphodepletion therapy for 3 to 5 days followed by intravenous infusion of CAR-T cells.
1 leukapheresis procedure, 3 to 5 days lymphodepletion therapy, and 1 infusion visit (all in-person)
Duration - Up to 12 weeks
Participants are followed for safety and efficacy evaluation up to 12 weeks after infusion.
Regular visits during the 12 weeks post-infusion for safety and efficacy assessments
Duration - At least 12 months
Participants with durable remission at 12 weeks after infusion are followed for at least 12 months for disease control.
Periodic visits during the 12 months post 12-week remission for disease control
Trial Site Locations
Total: 1 location
1
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, China, 650000
Actively Recruiting
Research Team
S
Sanbin Wang, Doctor
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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