A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults

NCT07470073 | Recruiting Early Phase 1

• 1 other identifier: CT1190B-CG11013
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.

Conditions

ALL (Acute B-Lymphoblastic Leukemia)

Keywords

ALL (Acute B-Lymphoblastic Leukemia); CT1190B; CAR-T

Outcome Measures

Primary Outcomes (2)

• The number and severity of dose-limiting toxicity (DLT)events

  DLT was collected to explore the maximum tolerated dose (MTD) and / or dose range of CT1190B

  Within 28 days after cell infusion

• Frequency, type and severity of AES

  The frequency, type and severity of adverse events (AES) were collected. All adverse events will be evaluated according to the common terminology criteria for adverse events (CTCAE, version 5.0).

  Within 12 months after cell infusion

Secondary Outcomes (10)

• Investigator assessed objective response rate (ORR)

  The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion

• Investigator assessed complete response rate (CRR)

  The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion

• Investigator assessed proportion of minimal residual disease negative (MRD)

  The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion

• Investigator assessed duration of remission (DOR)

  The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion

• Investigator assessed time to remission (TTR)

  The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion

Study Arms (1)

CT1190B CAR-T cells Injection

EXPERIMENTAL

The study drug was ct1190b car T-cell injection, and the car-cd19/cd20 gene was site integrated into T-cells by using replicable lentivirus (RCL) and adeno-associated virus (AAV) gene editing technology.

Biological: CT1190B cell injection

Interventions

CT1190B cell injection BIOLOGICAL

The active ingredient of the drug in this study is the chimeric antigen receptor targeting cd19/cd20 (car-cd19/cd20 for short) modified allogeneic T cells. In order to reduce the rejection of GVHD and host immune cells, TCR and B2M were knocked out, and the related modifications were also carried out to reduce the host NK cell immune rejection.

Also known as: CT1190B

CT1190B CAR-T cells Injection

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; ;
• aged 12-75 years (inclusive);
• relapsed / refractory B-ALL diagnosed by morphology, immunology or molecular science, and meeting one of the following conditions:
• The patients who did not achieve complete remission by the standardized induction chemotherapy, or early relapse (\<12 months) after complete remission, or late relapse (≥ 12 months) after complete remission, and did not achieve complete remission by the standardized one course induction chemotherapy (except for the patients with late relapse who did not have a better treatment or did not tolerate other treatments according to the investigator's assessment), relapsed after 2 or more CR or CRI;
• For ph+all patients, in addition to receiving standard induction chemotherapy, they should also receive at least two kinds of TKI treatment without complete remission or relapse after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment, or those with T315I mutation do not need to receive TKI treatment);
• CD19 and / or CD20 positive in bone marrow or peripheral blood;
• the proportion of bone marrow cell morphology or peripheral blood suggestive blasts ≥ 5%;
• estimated survival \>12 weeks;
• study participants should meet the following inspection results (there should be no ongoing continuous supportive care):
• Endogenous creatinine clearance ≥ 30 ml/min (using Cockcroft Gault formula);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; In case of hepatobiliary invasion: AST and alt ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;
• International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
• Oxygen saturation in non oxygen inhalation state was \> 91%;
• Left ventricular ejection fraction (LVEF) ≥ 50%.
• Male study participants who had active sex with women with reproductive potential were willing to use very effective and reliable methods of contraception within 1 year after receiving study treatment. All male study participants were absolutely forbidden to donate sperm within 1 year after receiving study treatment infusion during the study period.

You may not qualify if:

• pregnant or lactating women;
• there is HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA is higher than the detection limit), or active hepatitis C virus infection (both HCV antibody and HCV-RNA are positive);
• there is currently any uncontrollable active infection, including but not limited to patients with active tuberculosis (judged by the investigator);
• there is active systemic autoimmune disease;
• patients with solitary extramedullary lesions;
• research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, severe brain injury, cerebellar disease, memory impairment, spinal cord compression or any disease involving the central nervous system, or suspected active central nervous system (CNS) metastasis;
• patients with bone marrow failure status related genetic syndromes: such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome were not excluded.
• for patients who relapsed after treatment with drugs targeting CD19 and / or CD20 before screening, the investigator judged that they could not benefit; 10. have received stem cell transplantation within 12 weeks before signing the informed consent; Received donor lymphocyte infusion (DLI) within 6 weeks;
• received the following treatments before cell infusion:
• Received anthracyclines, vinblastines, 6-mercaptopurine, 6-thioguanine, methotrexate, cytarabine, asparaginase, etc. within 7 days before infusion;
• Hydroxyurea and tyrosine kinase inhibitors were used within 3 days before infusion;
• Radiotherapy was used within 1 week before infusion (2 weeks interval for lung radiotherapy and 8 weeks interval for CNS radiotherapy);
• CNS prophylactic therapy (such as intrathecal injection of chemotherapeutic drugs) within 1 week before infusion;
• Give any T-cell lysis or antibody (such as alemtuzumab) within 8 weeks before infusion;
• Use monoclonal antibody, double antibody or ADC within 4 weeks before infusion;

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

Central Study Contacts

Heng Mei, M.D., Ph.D

CONTACT

07596503286; hmei@hust.edu.cn

Study Design

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

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)