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

B-ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04546906
• Other study ID #: CD22 CAR-T for B-ALL
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2020
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Peihua Lu, PhD&MD
• Phone: 008618611636172
• Email: peihua_lu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• B-ALL
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	BeiJing Ludaopei Hospital	Beijing	Yizhuang
China	Hebei yanda Ludaopei Hospital	Heibei	Sanhe

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence and severity of adverse events	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	First month post CAR-T cells infusion
Primary	Efficacy: Remission Rate	Remission Rate including complete remission(CR)?CR with incomplete blood count recovery(CRi)?No remission(NR)	3 months post CAR-T cells infusion
Secondary	Efficacy:duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
Secondary	Efficacy: progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion
Secondary	CAR-T proliferation	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	3 months post CAR-T cells infusion
Secondary	Cytokine release	Cytokine( IL-6,IL-10,IFN-?,TNF-a ) concentration (pg/mL) by flow cytometry method	First month post CAR-T cells infusion