CD79b CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma

NCT ID: NCT04609241

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2026-11-15

Brief Summary

A study of CD79b CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma

Detailed Description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 72 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Conditions

Relapsed and/or Refractory Acute Lymphoblastic Leukemia; Relapsed and/or Refractory B-cell Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration of CD79b CAR-T Cell

Group Type: EXPERIMENTAL

CD79b CAR-T Cells

Intervention Type: DRUG

Each subject receive CD79b CAR-Tcells by intravenous infusion

Interventions

CD79b CAR-T Cells

Each subject receive CD79b CAR-Tcells by intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Only For B-ALL

1. No gender or age limit

2. Histologically confirmed diagnosis of CD69b+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);

3. Relapsed or refractory CD123+ AML (meeting one of the following conditions):

1. CR not achieved after standardized chemotherapy;

2. CR achieved following the first induction, but CR duration is less than 12 months;

3. Ineffectively after first or multiple remedial treatments;

4. 2 or more relapses;

4. The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);

5. Philadelphia chromosome negative(Ph-) subjects; Ph+ subjects who cannot tolerate tyrosine kinase inhibitor (TKI) treatment or who do not respond to two kinds of TKI treatment;

• Only For B-NHL

1. No gender or age limit;

2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);

3. Relapsed or refractory B-NHL (meeting one of the following conditions):

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1. No response or relapse after second-line or above chemotherapy regimens;

2. Primary drug resistance;

3. Relapse after auto-HSCT;

4. At least one assessable tumor lesion per Lugano 2014 criteria

• For both B-ALL and B-NHL

1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;

2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;

3. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;

4. Estimated survival time ≥ 3 months;

5. ECOG performance status 0 to 2;

6. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Exclusion Criteria

• 1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 7. Insufficient amplification capacity in response to CD3 / CD28 co-stimulus signal (<5 times) 8. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; 9. Other uncontrolled diseases that were not suitable for this trial; 10. Patients with HIV infection; 11. Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

He Huang, PhD

Role: CONTACT

Phone: 86-13605714822

Email: huangheyu@126.com

Yongxian Hu, PhD

Role: CONTACT

Phone: 86-15957162012

Email: huyongxian2000@aliyun.com

Facility Contacts

He Huang, PhD

Role: primary

Other Identifiers

CD79b-001

Identifier Type: -

Identifier Source: org_study_id