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Safety, Efficacy and Pharmacokinetics of XKDCT023 in DLBCL

NCT05269914 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-08

No results posted yet for this study

Summary

This study is a phase I multicenter, single arm, open, dose increasing, single treatment clinical study. This study plans to recruit a total of about 10-16 adult patients with CD19 positive recurrent or refractory DLBCL for a single autologous car-t cell therapy. There are three dose groups in the study. The first dose group has one patient. If there is no dose limiting toxicity (DLT), it can be increased to the second dose group, otherwise it will continue to be enrolled according to the "3 + 3" method; The follow-up dose group is conducted according to the traditional "3 + 3" design, that is, three subjects are first enrolled in a dose group. If there is no dose limiting toxicity (DLT) in the three patients in the dose group, it can be increased to the next higher dose after completing the DLT observation period; If DLT occurs in 1 of the 3 patients in the dose group, it is necessary to continue to enroll 3 patients in the dose group for DLT observation. The highest dose level of DLT in less than or equal to 1 of the last 6 confirmed patients will be defined as MTD. The safety of car-t treatment was evaluated by observing the adverse events after cell therapy; Evaluate the effectiveness of car-t treatment compared with the results or historical data of the patient's own previous standard treatment regimen. Blood and bone marrow were collected before and 12 months after cell infusion, the number and activity of car-t cells were detected, and the pharmacokinetics (PK) of car-t cells was evaluated.

Conditions

Interventions

OTHER

Autologous anti-CD19 CAR-T cell injection

According to preclinical research, existing preliminary clinical data and similar approved therapeutic products (kte-c19 of Kate company, the trade name is yescarta ®） According to the clinical trial results, three doses (the number of cells per unit body weight) were selected as the therapeutic dose of this study. Among the patients who increased the dose according to the "3 + 3" design, the number of target cells in each dose group was: (1) the first dose group was 1.00 × 106 Car + T cells / kg, 20% dose error is allowed. (2) the second dose group is 3.00 × 106 Car + T cells / kg, 20% dose error is allowed. (3) the third dose group is 9.00 × 106 Car + T cells / kg, 20% dose error is allowed.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Days
Max Age
75 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2022-12-31
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269914 on ClinicalTrials.gov