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NCT04609241Not yet recruitingEarly phase 1

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

Clinical Trial for the Safety and Efficacy of Murine CD79b CAR-T Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma

Source: ClinicalTrials.gov · Last updated 30 Oct 2020 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
72 (estimated)
First submitted
23 Oct 2020
Start date
Nov 2020
Primary completion date
Nov 2023
Lead sponsor
Zhejiang University
NCT number
NCT04609241

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 72
  • From Nov 2020 to the primary completion date, Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Who the study is looking for

  • Only For B-ALL
    • No gender or age limit
    • Histologically confirmed diagnosis of CD69b+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
    • Relapsed or refractory CD123+ AML (meeting one of the following conditions):
    • CR not achieved after standardized chemotherapy;
    • CR achieved following the first induction, but CR duration is less than 12 months;
    • Ineffectively after first or multiple remedial treatments;
    • 2 or more relapses;
    • The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry);
    • 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
    • No gender or age limit;
    • Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
    • Relapsed or refractory B-NHL (meeting one of the following conditions):
    • <!-- -->
    • No response or relapse after second-line or above chemotherapy regimens;
    • Primary drug resistance;
    • Relapse after auto-HSCT;
    • At least one assessable tumor lesion per Lugano 2014 criteria
  • For both B-ALL and B-NHL
    • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
    • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
    • No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
    • Estimated survival time ≥ 3 months;
    • ECOG performance status 0 to 2;
    • Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital, College of Medicine, Zhejiang University
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.