About this trial
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with refractory ITP associated with autoimmune disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age: 18~60 years old; 2. Diagnosed with immune thrombocytopenia associated with autoimmune diseases including systemic lupus erythematosus (according to the 1997 or 2009 ACR classification criteria), primary Sjogren's syndrome (according to the 2002 ACR/EULAR international classification criteria), undifferentiated connective tissue disease (according to the 1999 international classification criteria). Or patient without clinical manifestations related to connective tissue disease, but with positive anti nuclear antibodies (≥ 1:100) and/or without positive anti SSA/Ro-52 antibodies;Serum creatinine <221.0μmol/L (2.5mg/dl); 3. platelet count<30 × 10 ⁹/L or platelet count ≥ 20 × 10 ⁹/L, accompanied by bleeding symptoms (bleeding symptom score ≥ 2 points). No obvious active infection; 4. Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative.
Disqualifiers
None
Trial design
Sequential
Treatments tested in this trial
BCMA-CD19 cCAR T cells
Biological/Vaccine• BCMA-CD19 cCAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
Treatment groups
Trial outcomes
Primary outcomes
The number and incidence of adverse events after BCMA-CD19 cCAR T cell infusion
Evaluation all possible adverse reactions, including the number, incidence, and severity of symptoms such as cytokine release syndromes and neurotoxicity within 3 months after BCMA-CD19 cCAR infusion.
Secondary outcomes
Overall remission rate 12 weeks after BCMA-CD19 cCAR
1. Complete response (CR): Platelet count ≥ 100 × 109/L and no bleeding; 2. Partial response (PR): platelet count\<100 × 109/L, but increased by at least 2 times compared to baseline platelet count, with no bleeding symptoms 3. Disease control: Disease control monitored up to 2 years after BCMA-CD19 cCAR T cells infusion)
Sponsors and contacts
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iCell Gene Therapeutics
Lead sponsor
iCell ImmunityX(Hangzhou)Co., Ltd.
Collaborator