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OncoMatch/Clinical Trials/NCT07053670

A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG11001 )

Is NCT07053670 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CAR T cells for b-cell non-hodgkin lymphoma.

Phase 1RecruitingTongji HospitalNCT07053670Data as of May 2026

Treatment: CAR T cellsA Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Allowed: CD20 expression

including anti-CD20 drugs (unless the investigator had determined that the tumor is/is CD20 negative)

Allowed: CD19 expression

Prior therapy targeting CD19 (unless CD19 or CD20 target remains positive)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: systemic therapy (anti-CD20 drugs, anthracycline) — Cohort A1: at least 2 lines, anti-CD20 drugs (unless CD20 negative), anthracycline-containing regimens

Cohort A1: Previously received at least 2 lines of systemic therapy, including anti-CD20 drugs (unless the investigator had determined that the tumor is/is CD20 negative) and anthracycline containing regimens

Must have received: systemic therapy (anthracycline, bendamustine, anti-CD20 drugs, BTK inhibitor) — Cohort A2: at least 2 lines, anthracycline or bendamustine-containing chemotherapy, anti-CD20 drugs (unless CD20 negative), BTK inhibitor

Cohort A2: at least 2 prior lines of systemic therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 drugs (unless the investigator had determined that the tumor is/is CD20 negative) and a BTK inhibitor

Must have received: systemic therapy (anti-CD20 drugs, anthracycline) — Cohort B1: at least 2 lines, anti-CD20 drugs (unless CD20 negative), anthracycline-containing chemotherapy regimens

Cohort B1: previously received at least 2 lines of systemic therapy, including anti-CD20 drugs (unless the investigator had determined that the tumor is/is CD20 negative) and anthracycline-containing chemotherapy regimens

Must have received: systemic therapy (immunotherapy, chemotherapy, BTK inhibitor) — Cohort B2: at least 2 prior lines, including immunotherapy or chemotherapy and a BTK inhibitor, or BTK inhibitor who are not suitable for immunotherapy or chemotherapy

Cohort B2: at least 2 prior lines of therapy, including immunotherapy or chemotherapy and a BTK inhibitor, or BTK inhibitor who are not suitable for immunotherapy or chemotherapy

Must have received: systemic therapy (methotrexate) — Cohort C: at least 1 line, including MTX based chemotherapy

Cohort C: at least 1 line of therapy, including MTX based chemotherapy

Cannot have received: autologous stem cell transplant

Exception: within 12 weeks prior to signing informed consent

Autologous stem cell transplantation within 12 weeks prior to signing informed consent

Cannot have received: CD19-targeted therapy

Exception: unless CD19 or CD20 target remains positive

Prior therapy targeting CD19 (unless CD19 or CD20 target remains positive)

Cannot have received: cytotoxic therapy

Exception: within 14 days or 5 half-lives before FC

Has received treatment for the disease within 14 days or 5 half-lives (Based on a shorter period of time ) before FC, including but not limited to cytotoxic therapy, monoclonal antibodies or ADCs, targeted therapy, radiotherapy, epigenetic therapy, or investigational agents, or invasive investigational medical devices within 14 days before informed consent

Cannot have received: systemic glucocorticoids (prednisone > 15 mg/day)

Exception: within 7 days prior to informed consent, except topical glucocorticoids

Systemic glucocorticoids equivalent to > 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids

Lab requirements

Blood counts

PLT ≥ 75 × 10^9/L (≥ 50 × 10^9/L if bone marrow/peripheral blood involvement); Hb ≥ 80 g/L (≥ 60 g/L if bone marrow/peripheral blood involvement); INR and APTT ≤ 1.5 × ULN

Kidney function

Endogenous creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)

Liver function

ALT and AST ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN; if liver involvement: AST and ALT ≤ 5 × ULN and total bilirubin ≤ 3.0 × ULN

Cardiac function

No NYHA Class III/IV heart failure, MI, CABG, or unstable angina within 6 months; no significant arrhythmia; no severe non-ischemic cardiomyopathy; LVEF ≥ 45%

CBC: platelet (PLT) ≥ 75 × 10^9/L (for participants with bone marrow or peripheral blood involvement: PLT ≥ 50 × 10^9/L), hemoglobin (Hb) ≥ 80 g/L (for participants with bone marrow or peripheral blood involvement: Hb ≥ 60 g/L); Endogenous creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula); ALT and AST ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN; if liver involvement: AST and ALT ≤ 5 × ULN and total bilirubin ≤ 3.0 × ULN; INR and APTT ≤ 1.5 × ULN; cardiac conditions excluded as listed

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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