CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

NCT04662294 | Recruiting Early Phase 1 DMC

• 1 other identifier: CD70-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Myeloid Leukemia; Non-hodgkin's Lymphoma; Multiple Myeloma

Keywords

CAR T-cell therapy; CD70; Acute Myeloid Leukemia; Non-Hodgkin's lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Baseline up to 28 days after CD70 targeted CAR T-cells infusion

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  Up to 2 years after CD70 targeted CAR T-cells infusion

Secondary Outcomes (13)

• Acute Myeloid Leukemia (AML), Overall response rate (ORR)

  At Month 1, 3, 6, 12, 18 and 24

• AML, Overall survival (OS)

  Up to 2 years after CD70 CAR-T cells infusion

• AML, Event-free survival (EFS)

  Up to 2 years after CD70 CAR-T cells infusion

• Non-Hodgkin's lymphoma (NHL), Overall response rate (ORR)

  At Month 1, 3, 6, 12, 18 and 24

• NHL, Overall survival (OS)

  Up to 2 years after CD70 CAR-T cells infusion

Study Arms (3)

T-ALL

EXPERIMENTAL

Biological: CD70 CAR T-cells

T-NHL

EXPERIMENTAL

Biological: CD70 CAR T-cells

AML

EXPERIMENTAL

Biological: CD70 CAR T-cells

Interventions

CD70 CAR T-cells BIOLOGICAL

Each subject receive CD70 CAR T-cells by intravenous infusion

Also known as: CD70 CAR-T cells injection

AML; T-ALL; T-NHL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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);

You may not qualify if:

• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Pregnant (or lactating) women;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
• Previously treated with any CAR-T cell product or other geneticallymodified T cell therapies;
• Creatinine \>2.5mg/dl, or ALT / AST\>3 times of normal amounts, or bilirubin\>2.0 mg/dl;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;
• Any situations that the investigator believes may increase the risk of patients or interfere with the results of study. -

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (2)

• Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3.

  PMID: 37093350 DERIVED

• Golubovskaya V. CAR-T Cells Targeting Immune Checkpoint Pathway Players. Front Biosci (Landmark Ed). 2022 Apr 2;27(4):121. doi: 10.31083/j.fbl2704121.

  PMID: 35468680 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin; Multiple Myeloma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: December 10, 2020
• Study Start: November 18, 2021
• Primary Completion: January 15, 2024
• Study Completion (Estimated): January 15, 2027
• Last Updated: November 4, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)