Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Yongtai Ruike Biotechnology Company Ltd

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • RC19D2 cell injection

    Biological/Vaccine

    The functional component of RC19D2 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors.

Treatment groups

25 Participants
are divided into 4 treatment groups
Group A: First dose groupExperimental treatment 1 intervention
Group B: Second dose groupExperimental treatment 1 intervention
Group C: Third dose groupExperimental treatment 1 intervention
Group D: Fourth dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MTD

Determine the maximum tolerable dose(MTD) based on the 28 day dose limit toxicity occurrence of all participants.

Time frame
28 days
2

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

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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