RD13-02 CAR-T Cell Injection for Patients With r/r CD7+ T-ALL/T-LBL
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: RD13-02 cell infusion
CAR-T cells
|
Outcome Measures
Primary Outcome Measures
- Overall response rate, ORR [Evaluate at 4 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).
- Overall response rate, ORR [Evaluate at 8 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).
- 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
- 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
- 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
- Event-free survival, EFS [Up to 1 years after CAR-T infusion]
The time from first achieving CR/CRi to relapse or death
- 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.
- Overall survival, OS [Up to 1 years after CAR-T infusion]
The time from CAR-T infusion to death due to any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
Sujects with concomitant genetic syndromes associated with bone marrow failure states.
-
Sujects with some cardiac conditions will be excluded.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui | China | 230002 |
Sponsors and Collaborators
- Xiaoyu Zhu
- Nanjing Bioheng Biotech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BHCT-RD13-02-08