A Phase 1 interventional study of TCR-MAGE-A4 T-Cells in Advanced Solid Tumor, sponsored by Peking University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Peking University · Phase 1, Interventional, and Treatment
A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.
This study is a single-arm, open-label, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of T-cell receptor-engineered T cell (TCR-T) targeting melanoma-associated antigen-4 (MAGE-A4) and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumors with positive MAGE-A4 expression and refractory to prior standard systemic treatments.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subjects enrolled will be sequentially assigned to the corresponding dose level.
Drug: TCR-MAGE-A4 T-Cells
* Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses * MAGE-A4-directed T cell receptor-engineered T Cells
Also known as: MAGE-A4-directed T cell receptor-engineered T Cells
Rate of dose-limiting toxicities (DLTs)
Dose-limiting toxicity (DLT) is defined as an adverse event that occurred within 28 days after JWTCR001 infusion that met any of the following criteria. Any Grade ≥3 non-hematologic toxicity associated with JWTCR001 that has not resolved to Grade ≤2 within 7 days, excluding clinically insignificant abnormalities in laboratory indicators. Grade ≥3 hematological toxicities. Grade ≥3 anaphylaxis. Grade ≥3 infection did not resolve to Grade ≤2 within 7 days after anti-infective treatment. Grade ≥3 autoimmune toxicity during treatment. Grade ≥3 cytokine release syndrome (CRS) during treatment that did not resolve to Grade ≤2 within 72 hours. Grade ≥3 TCR-T cell-associated encephalopathy syndrome/immune effector cell-associated neurotoxicity syndrome (CRES/ICANS) that did not resolve to Grade ≤2 within 72 hours. Grade 5 events of any nonmalignant cause.
Time frame: 28 days
Rate and severity of adverse events (AEs) and severe adverse events (SAEs)
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Time frame: 2 years
Rate and severity of clinically-significant abnormalities in laboratory testings
Clinically-significant abnormalities in laboratory testings.
Time frame: 2 years
Copy number of the vector transgene of JWTCR001 in peripheral blood
The pharmacokinetic parameters of JWTCR001 will be evaluated by quantitative polymerase chain reaction (qPCR) for the copy number of the vector transgene of JWTCR001 in peripheral blood to evaluate T-cell expansion and persistence.
Time frame: 2 years
MAGE-A4 specific TCR+ T Cell concentration of JWTCR001 in peripheral blood
The pharmacokinetic parameters of JWTCR001 will be evaluated by flow cytometry for the MAGE-A4 specific TCR+ T Cell concentration of JWTCR001 in peripheral blood to evaluate T cell expansion and persistence.
Time frame: 2 years
Antitumor efficacy-Progression-free survival (PFS)
The period from the day when the subject receives the infusion of cells to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.
Time frame: 2 years
Antitumor efficacy-Duration of response (DOR)
The number of cases in which response are achieved from the start of cell infusion/the total number of evaluable cases (%).
Time frame: 2 years
Antitumor efficacy-Time to response (TTR)
The time from the first infusion to the first objective tumor response (tumor shrinkage of ≥30%) observed for patients who achieved a CR or PR.
Time frame: 2 years
Antitumor efficacy-Overall survival (OS)
The period from the first infusion to any cause of death.
Time frame: 2 years
Antitumor efficacy-Objective response rate (ORR)
The number of cases in which tumor size is reduced to complete response (CR) or partial response (PR) / the total number of evaluable cases (%). In the event of CR or PR, the subjects should confirm it no less than 4 weeks after the first evaluation.
Time frame: 2 years
Antitumor efficacy-Disease control rate (DCR)
The number of cases in which response are achieved from the start of cell infusion/the total number of evaluable cases (%).
Time frame: 2 years
Plan to share: Yes
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Peking University