RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies
- Conditions
- Hematologic Malignancies
- Interventions
- Drug: RD13-02 cell infusion
- Registration Number
- NCT05923541
- Lead Sponsor
- Henan Cancer Hospital
- Brief Summary
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- Age 3-70
- Diagnosis of r/r T-ALL/LBL.
- CD7 positive expression
- Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) < 3×upper limit of normal, Total bilirubin < 1.5×upper limit of normal or ≤1.5mg/dl
- Left ventricular ejection fraction ≥ 50% .
- Baseline oxygen saturation ≥ 92% on room air.
- ECOG performance status of 0 to 2.
- The estimated survival time is more than 3 months.
- Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.
- Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- Isolated extramedullary lesions
- Subjects with some cardiac conditions will be excluded.
- With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade CNS3.
- History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
- History of malignancy other than non-melanoma skin cancer or carcinoma.
- Primary immune deficiency.
- Presence of uncontrolled infections.
- Sujects with some anticancer therapy before CAR-T infusion will be excluded.
- Active uncontrolled acute infections.
- Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
- Subjects who are receiving systemic steroid therapy prior to screening.
- Subjects with acute graft-versus-host disease (GvHD)
- Having received live/attenuated vaccine within 4 weeks prior to screening.
- History of allergy to any component of the cell therapy product.
- Pregnant or breastfeeding women
- Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RD13-02 cell infusion RD13-02 cell infusion drugs use generic name : RD13-02 CAR-T cell injection; dosage form : Cell injection; dosage : 2×10\^8 CAR+ T cells; frequency : Once.
- Primary Outcome Measures
Name Time Method Overall response rate, ORR Evaluate at 12 weeks after CAR-T infusion The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
- Secondary Outcome Measures
Name Time Method Duration of remission, DOR Up to 1 years after CAR-T infusion The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
The proportion of patients who receive hematopoietic stem cell transplantation Up to 1 years after CAR-T infusion The proportion of subjects who achieved remission after infusion who received HSCT
Event-free survival, EFS Up to 1 years after CAR-T infusion The time from first achieving CR/CRi to relapse or death
Overall survival, OS Up to 1 years after CAR-T infusion The time from CAR-T infusion to death due to any cause
Overall response rate with MRD-negative, MRD-ORR Up to 1 years after CAR-T infusion Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow
Trial Locations
- Locations (1)
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China