About this trial
This trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Understand and voluntarily sign the informed consent form;
Age ≥ 18 years old at the time of screening, regardless of gender;
Patients with diffuse large B-cell lymphoma who have been diagnosed as CD19 positive by histopathology and/or cytology, but have failed standard treatment in the early stage, and currently lack effective treatment methods for recurrent or refractory CD19 positive.
The regulations for the past treatment status of research participants are as follows (meeting at least one of them): 1.At least after sufficient second-line treatment (CD20 positive individuals must have already used sufficient amounts of CD20 targeted drugs and anthracycline drugs), recurrence, no remission, or progression; In the first two lines of treatment, if the optimal therapeutic effect is SD, then the line of treatment must have completed 2 cycles;2.Recurrence, unrelieved, or progression after autologous hematopoietic stem cell transplantation;
Disqualifiers
Individuals with a history of allergies to any component in cellular products;
Individuals with a history of allogeneic hematopoietic stem cell transplantation;
Individuals with a history of organ transplantation;
hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and/or hepatitis B core antibody (HBc Ab) are positive, and the HBV-DNA quantity is higher than the upper limit of normal value; Hepatitis C virus antibody (HCV Ab) is positive and HCV RNA quantification is higher than the upper limit of normal values; Positive for human immunodeficiency virus antibody (HIV-Ab); Positive anti Treponema pallidum antibody (TP Ab); Cytomegalovirus DNA quantification is higher than the upper limit of normal values; EB virus DNA quantification is higher than the upper limit of normal values;
Trial design
Sequential
Treatments tested in this trial
RC19D2 cell injection
Biological/VaccineThe functional component of RC19D2 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors.
Treatment groups
Trial outcomes
Primary outcomes
MTD
Determine the maximum tolerable dose(MTD) based on the 28 day dose limit toxicity occurrence of all participants.
AE Safety
Number of participants with Adverse event (AESI, ADR, SAE, etc.), with abnormal laboratory test results, abnormal vital signs, abnormal physical examination findings and abnormal 12 lead electrocardiogram readings
Sponsors and contacts
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