PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma

NCT07188610 | Recruiting Phase 2

• 1 other identifier: PG-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 15

Brief Summary

\*\*Translation:\*\* This clinical trial is designed as a single-arm, open-label, multicenter study. After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells. Following lymphodepletion pretreatment, a single infusion of PA3-17 injection will be administered. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations. In addition to the baseline period, the treatment phase will involve efficacy assessments at 4 weeks, 2 months, 3 months, and every 3 months thereafter, up to 24 months post-cell infusion. Tumor assessments will continue until disease progression (PD), initiation of new antitumor treatment, death, unacceptable toxicity, investigator decision, or subject's voluntary withdrawal, whichever occurs first.

Conditions

CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Three-month Objective Response Rate (ORR): Proportion of Composite Complete Response Rate (CRc: CR, CRh, CRi, MLFS) and PR

  Three months

Study Arms (1)

T cell injection targeting CD7 chimeric antigen receptor

EXPERIMENTAL

Biological: T cell injection targeting CD7 chimeric antigen receptor

Interventions

T cell injection targeting CD7 chimeric antigen receptor BIOLOGICAL

After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells, followed by lymphodepletion pretreatment and a single infusion of PA3-17 injection.

T cell injection targeting CD7 chimeric antigen receptor

Eligibility Criteria

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

You may qualify if:

• Age and Gender: ≥18 years old (inclusive), regardless of gender.
• Survival Expectancy: ≥3 months.
• Performance Status: ECOG score 0-1.
• Diagnosis: Confirmed acute T-cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) according to the WHO fifth edition of the "Classification of Hematopoietic and Lymphoid Tumors," including early T-cell precursor (ETP).
• Recurrent or Refractory Disease: Subjects with recurrent/refractory T-ALL/LBL (including ETP-ALL/LBL).
• Screening: Abnormal cells CD7 expression positive.
• Lesion Assessment: If the subject has only extramedullary lesions, they must have evaluable lesions.
• Meet the requirements of liver, kidney, heart, and lung functions.
• No Severe Mental Disorders.
• Informed Consent: Ability to understand the trial and signed informed consent form.

You may not qualify if:

• Known to have active or uncontrolled autoimmune diseases;
• Presence of GvHD;
• History of malignant tumors other than T-ALL/LBL within the past 5 years, except for adequately treated cervical intraepithelial neoplasia, basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ of the breast after radical surgery;
• Positive test results for hepatitis B, hepatitis C, syphilis, etc.;
• Severe heart disease;
• Unstable systemic diseases as judged by the investigator;
• Presence of active infection or uncontrollable infection requiring systemic treatment;
• Pregnant or breastfeeding women, and female subjects planning to conceive within 2 years after cell infusion, or male subjects whose partners plan to conceive within 2 years after cell infusion;
• Subjects who have received CAR-T therapy or other gene-modified cell therapy before screening;
• Participation in other clinical studies within 1 month before screening (end date of the last application of unapproved innovative drugs);
• Evidence of central nervous system involvement at the time of subject screening;
• Situations judged by the investigator as not suitable for cell preparation;
• Other circumstances deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead

Study Sites (15)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, 230000, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Sun Yat-sen University Cancer Center (SYSUCC)

Guangzhou, Guangdong, 510000, China

RECRUITING

The First Hospital of Harbin

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

Tongji Hospital, Tongji University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

West China Hospital, Sichuan University (WCHSU)

Chengdu, Sichuan, 610000, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

Central Study Contacts

Xiaojun Huang, MD

CONTACT

+86-13701389625; xjhrm@medmail.com.cn

Mingzhi Zhang, MD

CONTACT

037166295562; mingzhi_zhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)