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

Not Applicable

• Conditions: B-ALL
• Interventions: Biological: CD22 CAR-T

• Registration Number: NCT04546906
• Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Last Update Submitted: 2020-09-04
• Study First Posted: 2020-09-14
• Last Update Posted: 2020-09-14
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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）

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD22 CAR-T	CD22 CAR-T	Patients will be treated with CD22 CAR-T cells

Primary Outcome Measures

Name	Time	Method
Efficacy: Remission Rate	3 months post CAR-T cells infusion	Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
Safety: Incidence and severity of adverse events	First month post CAR-T cells infusion	To evaluate the possible adverse events occurred within first one month after CD22 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

Secondary Outcome Measures

Name	Time	Method
Efficacy:duration of response (DOR)	24 months post CAR-T cells infusion	duration of response (DOR)
Efficacy: progression-free survival (PFS)	24 months post CAR-T cells infusion	progression-free survival (PFS) time
CAR-T proliferation	3 months post CAR-T cells infusion	the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method
Cytokine release	First month post CAR-T cells infusion	Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Trial Locations

Locations (2)

BeiJing Ludaopei Hospital; 🇨🇳 Beijing, Yizhuang, China

Hebei yanda Ludaopei Hospital; 🇨🇳 Heibei, Sanhe, China