Phase I Clinical Trial of Dinorencel Injection (or RC19D2 Cell Injection) in the Treatment of CD19-positive Relapsed or Refractory Diffuse Large B-cell Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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;

• According to the 2023 NCCN Lymphoma Treatment Guidelines and the 4th edition of the WHO Lymphatic Tissue Tumor Classification in 2016, the following types were included in this trial:Diffuse large B-cell lymphoma (DLBCL) non-specific (DLBCL-NOS);Transforming follicular lymphoma (tFL);High grade B-cell lymphoma (HGBL) with MYC, BCL2, and/or BCL6 rearrangement;High grade B-cell lymphoma, non-specific (HGBL-NOS);Primary mediastinal large B-cell lymphoma (PMBL);Grade 3b follicular lymphoma (FL3b);

• Expected survival time ≥ 12 weeks;

• There are measurable target lesions in imaging: the length and diameter of lesions in lymph nodes ≥ 15mm, or extranodal lesions\>10mm (according to Lugano2014 standard); Lesions that have received radiotherapy in the past are considered measurable only when there is clear progress after completing radiotherapy;

• During screening, laboratory inspections must meet the following requirements:Neutrophil count ≥ 1.0 × 10\^9/L;Lymphocyte count ≥ 0.3 × 10\^9/L; Hemoglobin ≥ 70 g/L;Platelets ≥ 50 × 10\^9/L;Total serum bilirubin ≤ 2.0 × Upper limit of normal value (ULN);Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;Creatinine\<1.5 × ULN and endogenous creatinine clearance rate ≥ 60 mL/min (creatinine clearance rate Cockcroft Fault method: male creatinine clearance rate=\[(140 age) × Weight (kg)\]/\[0.818 × Creatinine( μ Mol/L)\]; Female creatinine clearance rate=\[(140 age) × Body weight (kg) × 0.85\]/\[0.818 × Creatinine( μ Mol/L)\].

• The lung function is good, and the blood oxygen saturation of the fingertip pulse under non oxygen inhalation is ≥ 92%;

• The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0 or 1;

• Head MRI shows no central nervous system lymphoma;

• Cardiac ultrasound shows left ventricular ejection fraction ≥ 50%; No clinically significant abnormal electrocardiogram findings; No clinically significant pericardial or pleural effusion;

• Adequate venous access (for single collection) and no other contraindications for blood cell separation;

• The screening period blood pregnancy test for female participants of childbearing age must be negative

Locations
Other Locations
China
Hematology Hospital of the Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
lugui Qiu, MD
qiulg@ihcams.ac.cn
13821266636
Backup
dehui Zou, MD
zoudehui@ihcams.ac.cn
13602100955
Time Frame
Start Date: 2023-09-05
Estimated Completion Date: 2026-12-05
Participants
Target number of participants: 25
Treatments
Experimental: First dose group
The initial dose is (0.5 ± 0.1) × 10\^6/kg, with 1 participant enrolled
Experimental: Second dose group
The second dose is (1.0 ± 0.2) × 10\^6/kg, with 3-6 study participants enrolled
Experimental: Third dose group
The third dose is (2.5± 0.5) × 10\^6/kg, with 3-6 study participants enrolled
Experimental: Fourth dose group
The fourth dose is (5± 1) × 10\^6/kg, with 3-6 study participants enrolled
Sponsors
Leads: Beijing Yongtai Ruike Biotechnology Company Ltd

This content was sourced from clinicaltrials.gov

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