A Clinical Study to Explore CT1195E in Patients With Relapsed/Refractory B-Cell Neoplasms

NCT07234045 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT2025117
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study to Explore the Safety, Efficacy and Cellular Metabolic Kinetics of CT1195E CAR-T Cells Injection in Patients with Relapsed/Refractory B-Cell Neoplasms

Conditions

Relapsed/Refractory B-cell Non-Hodgkin Lymphoma; Relapsed/Refractory B-cell ALL

Keywords

CT1195E

Outcome Measures

Primary Outcomes (2)

• To assess the severity and incidence of DLTs, treatment-related adverse events (TRAE), and adverse events of special interest (AESI) after CT1195E infusion

  12 months after CT1195E infusion

• MTD or dose range

  To explore the maximum tolerated dose (MTD) or dose range of CT1195E

  Up to 28 days after CAR-T cells infusion

Secondary Outcomes (8)

• 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 CT1195E infusion

• Minimal Residual Disease Negative (MRD-) Proportion (R/R B-ALL)

  12 months after CT1195E infusion

• Duration of response (DOR)

  12 months after CT1195E infusion

• Time to response (TTR)

  12 months after CT1195E infusion

Study Arms (1)

CAR-T cells chimeric antigen receptor T cells

EXPERIMENTAL

CT1195E cells infusion

Drug: CAR T cells chimeric antigenreceptor cells

Interventions

CAR T cells chimeric antigenreceptor cells DRUG

CT1195E cells infusion

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:

• \. Voluntary participation in the clinical study; I fully understand and are informed of this study and sign the informed consent form; Willing to follow and able to complete all study procedures; 2. Age 18-75 years (inclusive) 3. Histologically or cytologically confirmed diagnosis of R/R B-NHL according to the WHO classification of lymphoid hyperplasia and neoplasms, 5th Edition 2022, including:
• \) Cohort A1: large B-cell lymphoma, including diffuse large B-cell lymphoma unspecified (DLBCL, NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, large B-cell lymphoma transformed from follicular lymphoma (FLBL)/Grade 3b FL，transformations of indolent B-cell lymphomas; 2) Cohort A2: Mantle cell lymphoma (MCL); 3) Cohort B: follicular lymphoma grade 1-3a; 4. Prior Therapy Requirements:
• Cohort A1: Patients who have previously received standard systemic therapy, including regimens containing anti-CD20 drugs (except CD20 negative) and anthracyclines;
• Cohort A2: Prior standard systemic therapy, including an anti-CD20 agent (except CD20 negative) , anthracycline or bendamustine-containing regimen, and a BTK inhibitor;
• Cohort B: previously received standard systemic therapy, including regimens containing anti-CD20 drugs (except CD20 negative) regimen; 5. Intolerance during the last treatment, or the need for new treatment after the last adequate treatment as assessed by the investigator; 6. At least one of the following:
• \) As measured by CT: Nodal lesions \> 1.5 cm in long diameter or extranodal lesions \> 1.0 cm in long diameter and measurable in short axis; 2) As measured by PET: FDG uptake fraction of 4 or 5; 7. Estimated survival \> 12 weeks; 8. Eastern Cooperative Oncology Group (ECOG) score 0-1; 9. Participants should meet the following test results (there should be no ongoing supportive care):
• Hematology: ① Platelet (PLT) ≥ 75 × 109/L (study participants with bone marrow or peripheral blood involvement: PLT ≥ 50 × 109/L), ② Hemoglobin (Hb) ≥ 80 g/L (study participants with bone marrow or peripheral blood involvement: Hb ≥ 60 g/L);
• Endogenous creatinine clearance ≥ 50 mL/min, or creatinine ≤ 1.5 × ULN (using Cockcroft-Gault formula);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; If lymphoma invades the liver: AST and ALT ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;
• International normalized ratio (INR) and activated partial thromboplastin time (APTT) were required to be ≤ 1.5 × ULN.
• Oxygen saturation ≥ 92% in non-oxygen inhalation state;
• Left ventricular ejection fraction (LVEF) ≥ 50% (LVEF value near the cut-off value can be enrolled after adequate risk assessment by the investigator); 10. Female participants of child-bearing potential must have a negative pregnancy test at the time of screening and before receiving lymphodepletion therapy, be willing to use a highly effective and reliable method of contraception within 1 year after receiving study treatment, and absolutely prohibit egg donation within 1 year after receiving study treatment infusion during the study; A male participant, if sexually active with a female of childbearing potential, is willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment. All male participants absolutely refrain from donating sperm for 1 year after receiving study treatment infusion during the study.
• Voluntary participation in the clinical study; I fully understand and are informed of this study and sign the informed consent form; Willing to follow and able to complete all study procedures;
• Age 18-75 years (inclusive);
• Morphologically, immunologically, or molecularly confirmed diagnosis of R/R B-ALL (Cohort C) and 1 of the following criteria is met:

You may not qualify if:

• Pregnant or lactating females;
• Study participants with a history of neurological disease, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disorders or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis;
• Presence of HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);
• Current presence of any uncontrolled active infection, including but not limited to active tuberculosis study participants (as judged by the investigator);
• Known or suspected long-term active EBV infection, known history of HLH;
• The toxicities caused by previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE 5.0) ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator;
• Received autologous stem cell transplantation within 12 weeks before signing the informed consent form; Received allogeneic stem cell transplantation;
• Prior treatment targeting CD19 (unless the CD19 or CD20 target remains positive);
• Antineoplastic therapy, including but not limited to cytotoxic therapy, monoclonal antibodies or antibody conjugates, targeted therapy, radiotherapy, epigenetic therapy, or investigational drug therapy, or use of an invasive investigational medical device within 14 days or 5 half-lives (whichever is shorter) prior to cell infusion. Participants are eligible for the study regardless of the end date of radiotherapy if the radiation field covers ≤ 5% bone marrow reserve;
• Systemic corticosteroids equivalent to \> 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical corticosteroids;
• Vaccination with live attenuated vaccines, inactivated vaccines or RNA vaccines within 4 weeks prior to signing the informed consent form;
• Allergy or intolerance to CLD drugs, tocilizumab, or allergy to the components of CT1195E cell infusion preparation (dimethyl sulfoxide/DMSO); Or previous history of other severe allergies such as anaphylactic shock;
• Study participants with any of the following cardiac conditions:
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• New York Heart Association (NYHA) Class III or IV heart failure;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

China Institute of Hematology and Blood Diseases Hospital

Tianjin, Tianjin Municipality, 301617, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Liang Huang

CONTACT

13971600192; huangliang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-10

Locations

CN (1)