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OncoMatch/Clinical Trials/NCT06758713

Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies

Is NCT06758713 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CAR-T for multiple myeloma.

Phase 1RecruitingThe Third Affiliated Hospital of Southern Medical UniversityNCT06758713Data as of May 2026

Treatment: CAR-TThis is a single center, open-label, dose-escalation/expansion clinical study to evaluate the safety and effectiveness of Fourth-Generation CAR-T, and determine the recommended dose of the CAR T-cells for patients with Multiple Myeloma,B-cell lymphoma and other hematologic malignancies.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Non-Hodgkin Lymphoma

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Biomarker criteria

Required: CD19 positive

Required: CD7 positive

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: CAR-T cell therapy

Exception: targeting the same molecule

Having received CAR-T therapy targeting the same molecule

Cannot have received: immunotargeted therapy

Exception: targeting the same molecules

Having received other immunotargeted therapy targeting the same molecules

Cannot have received: allogeneic hematopoietic stem cell transplantation

Having received allogeneic hematopoietic stem cell transplantation

Cannot have received: gene therapy product

prior treatment with any gene therapy product in the past three months

Lab requirements

Blood counts

White blood cell count ≥ 3.0 × 10e9/L; Absolute neutrophil ≥ 1.0 × 10e9/L; Lymphocyte count ≥ 0.5 × 10e9/L; Platelet count ≥ 50 × 10e9/L (not required for leukemia, multiple myeloma, and lymphoma)

Kidney function

Serum creatinine ≤ 2.5 mg/dl

Liver function

Serum total bilirubin (TBIL) ≤ 2.5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN, or 5 ULN if liver dysfunction is primarily due to tumor invasion

Cardiac function

Good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 55%

The clinical trial values during the screening period meet the following criteria: 1. White blood cell count ≥ 3.0 × 10e9/L; Absolute neutrophil ≥ 1.0 × 10e9/L; Lymphocyte count ≥ 0.5 × 10e9/L. (The growth factor support is allowed, but growth factor must not have been received within 7 days prior to laboratory testing); 2. Platelet count ≥ 50 × 10e9/L (No blood transfusion support within 7 days prior to laboratory tests.); Note: Patients with leukemia, multiple myeloma, and lymphoma are not subject to the above blood picture requirements; 3. Biochemical indicators Serum total bilirubin (TBIL) ≤ 2.5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN, or 5 ULN if liver dysfunction is primarily due to tumor invasion); 6. Cardiac function: Subjects must have good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 55%;

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

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