Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-12-01

Brief Summary

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This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD22 CAR-T cell in the treatment of recurrent or refractory B-ALL

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Detailed Description

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The CARs consist of an anti-CD22 single-chain variable fragment（scFv）, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of CD22CAR-T in patients with recurrent or refractory B-ALL

The Secondary research objectives:

To investigate the cytokinetic characteristics of CD22CAR-T in patients with recurrent or refractory B-ALL

Conditions

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B-ALL

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CD22 CAR-T

Patients will be treated with CD22 CAR-T cells

Group Type EXPERIMENTAL

CD22 CAR-T

Intervention Type BIOLOGICAL

Biological: CD22 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

Interventions

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CD22 CAR-T

Biological: CD22 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Patients with relapsed and refractory acute B-lymphoblastic leukemia who have any of the following:

1. B-ALL patients with relapse (including bone marrow morphological relapse 1 and minimal residual relapse 2) after remission by chemotherapy or autologous stem cell transplantation;
2. Primary B-ALL patients who can not be completely relieved by more than two times of repeated chemotherapy;
3. High risk primary B-ALL patients who have not been relieved but are not suitable for re intensive therapy after 1-2 times of chemotherapy;
2. Flow cytometry (FCM) showed CD 22 positive in bone marrow or peripheral blood;
3. There should be at least one assessable lesion in B-ALL patients with simple extramedullary recurrence;
4. The activity state score of the Eastern Cooperative Oncology Group (ECOG) was less than or equal to 2;
5. The estimated survival time is more than 3 months;
6. Need to sign informed consent.

Exclusion Criteria

1. Serious cardiac insufficiency；
2. Has a history of severe pulmonary function damaging;
3. Other malignant tumors;
4. Serious infection or persistent infection and can not be effectively controlled；
5. Merging severe autoimmune diseases or immunodeficiency disease;
6. Patients with active hepatitis (HBV DNA or HCV RNA positive);
7. Patients with HIV infection or syphilis infection;
8. Has a history of serious allergies on Biological products (including antibiotics);
9. Being pregnant and lactating or having pregnancy within 12 months;
10. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study（including a history of serious mental illness, substance abuse and addiction）

Minimum Eligible Age

2 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No