Health TrialsbyHealthPanel

CD19/CD22 CAR-T as First-line Consolidation in Follicular Lymphoma

ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorLiping Dou

About this trial

The purpose of this study is to determine the efficacy and safety of CD19/CD22 Chimeric Antigen Receptor (CAR) T-Cell immunotherapy as first-line consolidation therapy in patients with follicular lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. With the patient's consent and signed informed consent form, willing and able to comply with the planned visits, research treatments, laboratory tests, and other experimental procedures;

The patient's disease is still evaluated as partial response (PR) after induction treatment with standard first-line chemotherapy regimen, or

The patient's disease reaches complete response (CR) after induction treatment with standard first-line chemotherapy regimen, but there are high-risk factors at the time of onset;

Follicular Lymphoma International Prognostic Index (FLIPI-1) score of 3-5 or FLIPI-2 score of 3-5;

Disqualifiers

1. Have received any form of chimeric antigen receptor cell therapy or other genetically modified T cell therapy;

2. Has a history of severe immediate hypersensitivity reactions to aminoglycoside antibiotics and other essential medications;

HBV DNA quantification ≥ 2000 IU/ml;

ALT ≥ 2 times the normal upper limit value;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD22/CD19 CAR-T cell immunotherapy

    Biological/Vaccine

    Autologous T cells were collected and genetically modified to express chimeric antigen receptors targeting CD19 and CD22. Following lymphodepleting chemotherapy, patients received a single intravenous infusion of CD19/CD22 CAR-T cells.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: CD22/CD19 CAR-T cell immunotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-year progression free survival rate (1-year-PFSR)

The 1-year progression-free survival rate (1-year PFSR) is defined as the proportion of patients who are alive and progression-free at 1 year after CAR-T cell infusion.

Time frame
2 year after treatment

Secondary outcomes

1

overall survival (OS)

Overall survival (OS) refers to the time from the start of treatment to the death of the patient for any reason.

Time frame
2 years after treatment
2

progression free survival (PFS)

Progression free survival (PFS) refers to the time from treatment to the first lymphoma progression or death of the patient for any reason.

Time frame
2 years after treatment
3

disease free survival (DFS)

Disease free survival (DFS) refers to the time from treatment to the first lymphoma recurrence.

Time frame
2 years after treatment
4

duration of response (DOR)

Duration of Response (DOR) refers to the time from the first assessment of a lymphoma as a complete or partial response to the first assessment of PD (Progressive Disease) or death from any cause.

Time frame
2 years after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liping Dou

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov
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