Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Zeno Therapeutics Pte. Ltd | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1/Phase 2 open-label, single-arm clinical study of GP350 CAR-T for Relapse/Refractory and Epstein-Barr virus infection associated lymphoid neoplasms.
Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T cells.
Each participant will proceed through the following study procedures:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP350 CAR-T | Biological | Lymphodepletion chemotherapy with fludarabine (25 mg/m²/day) and cyclophosphamide (250 mg/m²/day) should be administered for 2-3 consecutive days, with the final dose completed 48 hours before infusion. Alternatively, investigators may individualize this regimen based on the subject's specific clinical circumstances. The target dose of GP350 CAR-T cells is 1.0-5.0×10⁶ CAR-T cells per kilogram of body weight, administered via intravenous injection. (The actual infused dose is allowed to vary within ±20% from the target dose, depending on the as-released product yield) Patients with less than partial response AND without > Grade 2 CRS or any ICANS may receive 1 to 2 additional infusion of GP350 CAR-T cells at the same dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The percentage of patients with complete response (CR) and partial response (PR) according to the RECIL 2017 criteria determined by the study investigators | Month 12 post CAR-T infusion |
| EBV DNA clearance rate | Defined as the proportion of patients achieving two consecutive negative tests in plasma or whole blood at least 7 days apart following treatment, relative to the total treated population | Month 12 post CAR-T infusion |
| Treatment Emergent Adverse Event (TEAE) | TEAE is defined as an adverse event that occurs or worsens after receiving the first dose of the trial drug | Within 3 months post-infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the GP350 CAR-T infusion date to the date of disease progression | 1 yesr post CAR-T infusion |
| Overall Survival (OS) | OS is the time from date of GP350 CAR-T infusion to the date of death due to any reason |
Not provided
Inclusion Criteria:
Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);
Disease Assessment:
Performance Status: ECOG score 0-2 and expected survival ≥3 months;
Age: 18-70 years, regardless of sex;
Hematologic Criteria:
Organ Function:
Contraception:
Informed Consent: Psychologically stable, capable of understanding the study's purpose and procedures, willing to participate voluntarily, and able to provide signed informed consent and comply with protocol requirements.
Exclusion Criteria:
Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);
Immunosuppression:
Cardiac Dysfunction:
Pregnancy/Contraception:
Hepatic/Renal Impairment:
Allergies: History of severe hypersensitivity to any study drugs;
Prior Stem Cell Transplant: Must have discontinued immunosuppressants for >6 weeks post-transplant with no signs of graft-versus-host disease (GVHD);
Other Exclusionary Conditions: Any other condition deemed unsuitable by the investigator (e.g., coagulation disorders, hemolytic anemia, etc.).
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Zhai, MD | Contact | +86-0551-63869571 | zzzm889@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230031 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1 yesr post CAR-T infusion |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |