A Clinical Trial of TAA06 Injection in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05190185

Recruitment Status : Recruiting

First Posted : January 13, 2022

Last Update Posted : January 13, 2022

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Department of Immunology, The Fourth Hospital of Hebei Medical University

Information provided by (Responsible Party):

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Tracking Information

First Submitted Date ^ICMJE

December 29, 2021

First Posted Date ^ICMJE

January 13, 2022

Last Update Posted Date

January 13, 2022

Actual Study Start Date ^ICMJE

June 1, 2021

Estimated Primary Completion Date

December 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assessment of the safety after B7-H3 chimeric antigen receptor T cells infusion (Safety) [ Time Frame: 3 months ]

Incidence and treatment-relativity of adverse events assessed by NCI CTCAE v5.0.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

To evaluate anti-tumor activity (overall response rate) [ Time Frame: 6 months ]
Rate of participants achieving a complete response (CR) or partial response (PR).
To evaluate anti-tumor activity (disease control rate) [ Time Frame: 3 months ]
Rate of participants achieving a complete response (CR) or partial response (PR) or stable disease (PD).
To evaluate anti-tumor activity (duration of response) [ Time Frame: About 2 years ]
Defined as the time from the first tumor assessment of CR or PR to the first assessment of disease progression (PD) or death from any cause.
To evaluate anti-tumor activity (Progression Free Survival) [ Time Frame: About 2 years ]
Defined as the time from the date of study enrollment to the time when the investigator judges that imaging disease progression or death from any cause occurs.
To evaluate anti-tumor activity (overall survival) [ Time Frame: About 2 years ]
Defined as the time from start of the random beginning to death (due to any cause).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Clinical Trial of TAA06 Injection in Advanced Solid Tumors

Official Title ^ICMJE

A Clinical Trial of TAA06 Injection in Advanced Solid Tumors

Brief Summary

B7-H3 (also known as CD276) is widely expressed on the surface of a variety of malignancies solid tumors, while it rarely or even doesn't express on normal tissues. Therefore, B7-H3 is an ideal target for chimeric antigen receptor (CAR) T cells therapy. TAA06 injection is a CAR T injection targeting B7-H3. This is a phase I clinical study with the primary objective of evaluating the safety and tolerability of TAA06 injection in subjects with TAA06-positive advanced solid tumors. The secondary objectives are as follows: to evaluate the distribution, proliferation and persistence of B7-H3-targeted CAR T cells after injection of TAA06 in subjects; to preliminarily evaluate the efficacy of TAA06 injection in subjects with TAA06-positive advanced solid tumor.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Malignant Melanoma, Lung Cancer, or Colorectal Cancer

Intervention ^ICMJE

Biological: TAA06 injection

The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be treated with 1×106~1×108 CAR-T/kg. And the subjects will be administered once.

Study Arms ^ICMJE

Experimental: TAA06 injection

T cell injection targeting B7-H3 chimeric antigen receptor

Intervention: Biological: TAA06 injection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 1, 2023

Estimated Primary Completion Date

December 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

(1) Aged 18 to 70 years old (inclusive), male or female;
(2) Expected survival time ≥ 12 weeks;
(3) ECOG performance status of 0-1;
(4) It is clearly diagnosed by pathology to be any of the following tumor types: malignant melanoma, lung cancer or colorectal cancer, and the positive rate of TAA06 expression in tumor tissues is ≥1% after immunohistochemical detection;
(5) Subjects whose standard treatment methods are ineffective (eg: relapse after surgery, disease progress after treatment with chemotherapy, radiotherapy or targeted drugs);
(6) According to the curative effect evaluation standard for solid tumors (RECIST 1.1), at least one measurable lesion (the longest diameter of the solid lesion ≥ 10mm, or the short diameter of the lymph node lesion ≥ 15mm);
(7) The main organ function is normal (white blood cell count ≥3×109/L, neutrophil count ≥1.5×109/L, hemoglobin ≥8.5g/dL, platelet count ≥80×109/L, lymphocyte count at 1×109/L (inclusive) ~ 4×109/L (inclusive));
(8) Liver and kidney function, heart and lung function meet the following criteria:
1. Urea (Urea) and serum creatinine≤1.5×ULN;
2. Left ventricular ejection fraction ≥50%;
3. Baseline blood oxygen saturation ≥ 94%;
4. Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN;
(9) The subjects or his legal representative can fully understand the significance and risks of this trial and has signed informed consents.

Exclusion Criteria:

(1) Subjects with a history of immunodeficiency or autoimmune diseases (including but not limited to rheumatoid joint disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); with graft-versus-host disease (GVHD) , Or those who need to use immunosuppressive agents;
(2) Subjects with other type of malignant tumors within 5 years prior to screening;
(3) Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test;
(4) Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia;
(5) Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
(6) Within 7 days prior to screening, there are active or uncontrollable infections requiring systemic therapy (except for mild genitourinary infection and upper respiratory tract infection);
(7) Pregnant or lactating women, and female subjects who plan to become pregnant within 1 year after cell infusion or male subjects whose partners plan to become pregnant within 1 year after cell infusion;
(8) Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening;
(9) Subjects who are receiving systemic steroid therapy within 7 days prior to screening or need long-term use of systemic steroid therapy during treatment as judged by the investigator (except for inhalation or topical use);
(10) Subjects with more than a moderate amount of ascites, or after conservative medical treatment (such as diuresis, sodium restriction, excluding ascites drainage) for 2 weeks, the ascites still shows a progressive increase;
(11) Conditions not eligible for cell preparation as judged by the investigator;
(12) Other conditions considered unsuitable for enrollment by the investigator.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 70 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Zhiyu Wang, Doctor

+86-138 3119 5070

drwangzhiyu@hebmu.edu.cn

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05190185

Other Study ID Numbers ^ICMJE

PG-CART-TAA06-001

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Department of Immunology, The Fourth Hospital of Hebei Medical University

Investigators ^ICMJE

Not Provided

PRS Account

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Verification Date

December 2021

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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