UnknownPhase 1/2

Phase I/II Study of αPD1-MSLN-CAR T Cells in MSLN-positive Advanced Solid Tumors

China42 participantsStarted 2023-09

Plain-language summary

An open, multicenter, phase I/II study to evaluate the safety, tolerability, and effectiveness of αPD1-MSLN-CAR T cells in patients With MSLN-positive advanced solid tumors

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Adequate bone marrow function in the opinion of the Investigator for lymphocyte-depleting chemotherapy: absolute neutrophil count must be greater than ≥ 1.5×109/L, lymphocyte count must be greater than ≥ 0.5×109/L, platelets must be greater than ≥ 90×109/ L, hemoglobin must be greater than ≥ 90g/L without transfusion within 7 days or dependency on EPO;
✓. Total bilirubin must be less than or equal to two times (≤2.0x) the institutional normal upper limit; transaminases, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST), must be less than or equal to 2.5 times (≤2.5x) the institutional normal upper limit (≤2.5x if there is hepatic metastasis);
✓. Creatinine must be less than or equal to one and one half times (≤ 1.5x) the institutional normal upper limit or eGFR ≥ 60ml/ min/1.73m\^2 \[eGFR=186×#age#-0.203×SCr-1.154#mg/dl#,for female the eGFR shoud be timed by 0.742\];
✓. International normalized ratio (INR) or the PT is not greater than one and one half times (≤ 1.5) the upper limit of normal;
✓. Lung function: ≤ CTCAE grade 1 dyspnea and SaO2≥ 91%
✓. Cardiac function: cardiac ejection fraction (LVEF) must be greater than fifty percent (≥50%) by echocardiogram or MUGA one month before enrollment.
✓. Systemic therapeutic corticosteroids must be stopped 72 hours before CAR-T infusion. However, patients using physiologic replacement doses of corticosteroids, or its equivalent, will be considered eligible;
✓. Immunosuppressive therapy must be stopped within four (4) weeks prior to enrollment;

Exclusion criteria

✕. Patients with in situ cervical cancer or breast cancer with no evidence of disease for ≥ 3 years after curative treatments;
✕. Patients who underwent successful definitive resection of in situ cancer with no evidence of disease for ≥5 years;

What they're measuring

Phase Ib: Incidence of Treatment Related adverse events (AEs)

Timeframe: Up to 12 months

Phase Ib: Identification of Maximum Tolerated Dose (MTD)

Timeframe: day1-day28

Phase II: Objective Response Rate (ORR), as assessed by IRC

Timeframe: Up to 12 months

Trial details

NCT IDNCT05944185

SponsorShanghai Cell Therapy Group Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09

Contact for this trial

Jie Wang

13910704669 zlhuxi@163.com

View on ClinicalTrials.gov More Advanced Solid Tumor trials