A Clinical Study Exploring Universal CAR-T Cell in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

NCT07043218 | Not Yet Recruiting Phase 1

• 1 other identifier: CT119X-CG11004
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT119X(including CT1190-P and CT1192) CAR-T Cell therapy, in Patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia.

Conditions

B-cell Acute Lymphoblastic Leukemia

Keywords

CT119X

Outcome Measures

Primary Outcomes (2)

• MTD and/or dose range

  Evaluate Dose limited toxicity and recommended dosage range after CT119X infusion

  Up to 28 days after CAR-T cells infusion

• Adverse Events (AE) after CT119X infusion

  An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria

  12 months after CT119X infusion

Secondary Outcomes (7)

• Overall response rate （ORR）

  Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion

• Complete response rate (CRR)

  12 months after CT119X infusion

• Duration of remission(DOR)

  12 months after CT119X infusion

• Time to response (TTR)

  12 months after CT119X infusion

• Time to complete response (TTCR)

  12 months after CT119X infusion

Study Arms (1)

CAR-T cells（ chimeric antigen receptor T cells）

EXPERIMENTAL

CT1190B-P and CT1192 cells infusion

Drug: Chimeric Antigen Receptor T Cells (CAR-T)

Interventions

Chimeric Antigen Receptor T Cells (CAR-T) DRUG

chimeric antigen receptor T cells

CAR-T cells（ chimeric antigen receptor T cells）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements
• years old;
• Histologically or cytologically confirmed B-ALL;
• Previously received at least 2 lines of systemic therapy;
• Expected survival \> 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) score 0-2;
• Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy。Both male and Female are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating sperm donation or eggs for 1 year after receiving study treatment infusion during the study.

You may not qualify if:

• Pregnant or lactating women;
• Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis Cvirus infection (HCV antibody and HCV-DNA positive);
• Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);
• Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade1, except alopecia and other events that are judged tolerable by the investigator;
• Patients with isolated extramedullary lesions;
• Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;
• Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;
• Patients with heart disease in the 6 months prior to screening;
• Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;
• Serious pulmonary diseases that are judged by the investigator to potentially endanger the patient's life when participating in the study.

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Aibin Liang MD,Ph.D.

  Shanghai Tongji Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aibin Liang MD,Ph.D.

CONTACT

+86 21 6611 1019; lab7182@tongji.edu.cn

Ping Li MD

CONTACT

+86 135 6418 1131; lilyforever@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: June 29, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)