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Not yet recruitingNCT07043218Updated Jun 29, 2025

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

A Phase 1 interventional study of Chimeric Antigen Receptor T Cells (CAR-T) in B-cell Acute Lymphoblastic Leukemia, sponsored by Shanghai Tongji Hospital, Tongji University School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Shanghai Tongji Hospital, Tongji University School of Medicine · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT119X (including CT1190-P and CT1192)cells in patients with B-ALL. It is planned to enroll 6-36participants.

02

Conditions studied

  • B-cell Acute Lymphoblastic Leukemia

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Keywords

  • CT119X
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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
  2. 18-75 years old;
  3. Histologically or cytologically confirmed B-ALL;
  4. Previously received at least 2 lines of systemic therapy;
  5. Expected survival > 12 weeks;
  6. Eastern Cooperative Oncology Group (ECOG) score 0-2;
  7. 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.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. 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);
  3. Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);
  4. 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;
  5. Patients with isolated extramedullary lesions;
  6. Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;
  7. Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;
  8. Patients with heart disease in the 6 months prior to screening;
  9. Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;
  10. Serious pulmonary diseases that are judged by the investigator to potentially endanger the patient's life when participating in the study.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    CAR-T cells( chimeric antigen receptor T cells)

    CT1190B-P and CT1192 cells infusion

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

Interventions

  • DrugChimeric Antigen Receptor T Cells (CAR-T)

    chimeric antigen receptor T cells

05

What researchers measure

Primary outcomes

  1. MTD and/or dose range

    Evaluate Dose limited toxicity and recommended dosage range after CT119X infusion

    Time frame: Up to 28 days after CAR-T cells infusion

  2. Adverse Events (AE) after CT119X infusion

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

    Time frame: 12 months after CT119X infusion

Secondary outcomes

  1. Overall response rate (ORR)

    The proportion of patients with complete remission(CR)/partial response (PR) after CT119X infusion.

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

  2. Complete response rate (CRR)

    The proportion of patients with complete response(CR) after CT119X infusion

    Time frame: 12 months after CT119X infusion

  3. Duration of remission(DOR)

    Participants achieving CR/PR will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first.

    Time frame: 12 months after CT119X infusion

  4. Time to response (TTR)

    The time from cell infusion to the first assessment of CR or PR

    Time frame: 12 months after CT119X infusion

  5. Time to complete response (TTCR)

    The time from cell infusion to the first assessment of CR

    Time frame: 12 months after CT119X infusion

  6. Progression-free survival (PFS)

    The time from the infusion of CT119X cells to the first assessment of disease progression or death.

    Time frame: 12 months after CT119X infusion

  7. Overall survival (OS)

    defined as the time from the date of receiving the infusion to the date of death from any cause

    Time frame: 12 months after CT119X infusion

06

Study locations

1 site
  • Shanghai Tongji Hospital
    Shanghai, Shanghai Municipality 200065, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07043218
Lead sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
Responsible party
Aibin Liang,MD,Ph.D. (Principal Investigator, Shanghai Tongji Hospital, Tongji University School of Medicine) — Principal investigator
First posted
Jun 29, 2025
Start date
Jul 10, 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jun 29, 2025

Study contacts

Aibin Liang MD,Ph.D.
Contact
lab7182@tongji.edu.cn
+86 21 6611 1019
Ping Li MD
Contact
lilyforever@126.com
+86 135 6418 1131
Aibin Liang MD,Ph.D.
principal investigator · Shanghai Tongji Hospital, Tongji University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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