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

Zhejiang University

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Relapsed and/or Refractory Acute Lymphoblastic Leukemia

Relapsed and/or Refractory B-cell Non-Hodgkin's Lymphoma

Treatments

Drug: CD79b CAR-T Cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04609241

CD79b-001

Details and patient eligibility

About

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

Full 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.

Enrollment

72 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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):

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.