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

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

Study Overview

• Status: Unknown
• Conditions: B-ALL
• Intervention / Treatment: Biological: CD22 CAR-T

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sanhe
    • Heibei, Sanhe, China, 065200
      • Recruiting
      • Hebei yanda Ludaopei Hospital
  • Yizhuang
    • Beijing, Yizhuang, China, 100000
      • Recruiting
      • BeiJing Ludaopei Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD22 CAR-T; Patients will be treated with CD22 CAR-T cells	Biological: CD22 CAR-T; Biological: CD22 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy:duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion
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
Cytokine release	Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method	First month post CAR-T cells infusion

Collaborators and Investigators

• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Investigators: Principal Investigator: Peihua Lu, PhD&MD, Hebei yanda Ludaopei Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: CD22 CAR-T， B-ALL
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: CD22 CAR-T for B-ALL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No