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Immunotherapy With CD22 CAR T-cells for B-Cell Lymphoma, ALL and CLL

NCT ID: NCT04163575

Last Updated: 2019-12-23

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

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-07-01

Brief Summary

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This study aims to evaluate the safety, efficacy and duration of response of CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD22+ haematological malignancies.

Detailed Description

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This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD22 Chimeric Antigen Receptor (CAR) T-cells (CD22 CAR T-cells) in patients with high risk, relapsed CD22+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD22 CAR Tcells. Patients will receive the CD22CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD22 CAR T-cells in patients with high risk relapsed CD22+ malignancies

Conditions

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Leukemia Lymphoma

Keywords

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CAR-T Leukemia lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental:1

Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.

Group Type EXPERIMENTAL

:Anti-CD22-CAR

Intervention Type BIOLOGICAL

Cells extracted, followed by induction chemotherapy before CD22-CAR infusion (dose escalation.)

experimental:2

Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.

Group Type EXPERIMENTAL

:Anti-CD22-CAR

Intervention Type BIOLOGICAL

Cells extracted, followed by induction chemotherapy before CD22-CAR infusion (dose escalation.)

experimental:3

Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD22-CAR) targeting CD22.

Group Type EXPERIMENTAL

:Anti-CD22-CAR

Intervention Type BIOLOGICAL

Cells extracted, followed by induction chemotherapy before CD22-CAR infusion (dose escalation.)

Interventions

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:Anti-CD22-CAR

Cells extracted, followed by induction chemotherapy before CD22-CAR infusion (dose escalation.)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 2 years to 70 years.
5. CD22 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to

Exclusion Criteria

1. KPS\<50.
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.
Minimum Eligible Age

2 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Yanda Ludaopei Hospital

OTHER

Sponsor Role collaborator

Kecellitics Biotech Company Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li xiangqun

Role: STUDY_CHAIR

Kecellitics Biotech Company Ltd

Central Contacts

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Li xiangqun

Role: CONTACT

Phone: 086-15712867910

Email: [email protected]

Other Identifiers

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Kece-2

Identifier Type: -

Identifier Source: org_study_id