Research Development（RD）13-02 Chimeric Antigen Receptor(C... | NCT05907603

NCT05907603

Status Module

Name	Class
Nanjing Bioheng Biotech Co., Ltd.	INDUSTRY

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Research Development 13(RD13)-02 cell infusion	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
RD13-02 cell infusion	Drug	CAR-T cells	Research Development 13(RD13)-02 cell infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall response rate (ORR)	The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) .	Evaluate at 4 weeks after CAR-T infusion
Overall response rate, ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .	Evaluate at 8 weeks after CAR-T infusion
Overall response rate, ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .	Evaluate at 12 weeks after CAR-T infusion

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate , ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR).	Up to 1 years after CAR-T infusion
Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 3-70
Diagnosis of r/r T-ALL/LBL/AML.
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.
Eastern Cooperative Oncology Group (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:

For AML patients, there are acute promyelocytic leukemia (APL) and Abelson Murine Leukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemia with acute(CML)-BC).
Subjects with concomitant genetic syndromes associated with bone marrow failure states.
Subjects 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.
Subjects 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 subjects ineligible for the study.

ID	Term
D009371	Neoplasms by Site
D006425	Hemic and Lymphatic Diseases