Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

Who is this study for? Patients with Leukemia
What treatments are being studied? CD70 CAR T-cells
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);

• Relapsed or refractory CD70+ 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);

• 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.

• No gender and 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 CD70+ 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

• Histologically confirmed diagnosis of CD70 multiple myeloma (MM):

‣ According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis was recurrent / refractory multiple myeloma

⁃ Cases with recurrent positive minimal residual disease;

⁃ Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

• No gender and age limit;

• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, 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.

∙ Common inclusion criteria :

• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;

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

• No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;

• Estimated survival time ≥ 3 months;

• ECOG performance status 0 to 2;

• Patients or their legal guardians volunteer to participate in the study and sign the informed consent -

Locations
Other Locations
China
The first affiliated hospital of medical college of zhejiang university
RECRUITING
Hangzhou
Contact Information
Primary
He Huang, PhD
hehuangyu@126.com
86-13605714822
Backup
Yongxian Hu, PhD
huyongxian2000@aliyun.com
86-15957162012
Time Frame
Start Date: 2021-11-18
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 108
Treatments
Experimental: T-ALL
Experimental: T-NHL
Experimental: AML
Sponsors
Collaborators: Yake Biotechnology Ltd.
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov

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