a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL

ConditionB-ALL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-75
SponsorChongqing Precision Biotech Co., Ltd

About this trial

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent

Failed to standard chemotherapy regimens;

Relapse after complete remission, high-risk and / or refractory patients ;

Relapse after hematopoietic stem cell transplantation;

Disqualifiers

Previous history of other malignancy;

Presence of uncontrolled active infection;

Evidence of disorder that need the treatment by glucocorticoids;

Active or chronic GVHD

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19 and CD22 targeted prime CAR-T cells

    Biological/Vaccine

    A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: prime CAR- T cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events that related to treatment

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

Time frame
2 years
2

The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B-ALL

The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline

Time frame
6 months

Secondary outcomes

1

Rate of prime CAR-T cells in bone marrow

Determine the rate of prime CAR-T cells in bone marrow by flow cytometry

Time frame
2 years
2

Rate of prime CAR-T cells in peripheral blood

Determine the rate of prime CAR-T cells in peripheral blood by flow cytometry

Time frame
2 years
3

Quantity of prime CAR copies in bone marrow

Determine the quantity of prime CAR copies in bone marrow by qPCR

Time frame
2 years
4

Quantity of prime CAR copies in peripheral blood

Determine the quantity of prime CAR copies in peripheral blood by qPCR

Time frame
2 years

Other outcomes

Sponsors and contacts

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