To hear about similar clinical trials, please enter your email below

Trial Title: The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia

NCT ID: NCT06307600

Condition: B Lymphoblastic Leukemia/Lymphoma

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid

Study type: Interventional

Study phase: Early Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: RD06-03 cell injection
Description: The patients in this intervention will use RD06-03 cell injection
Arm group label: RD06-03 cell infusion

Other name: RD06-03

Summary: This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia.

Detailed description: The study completes the enrollment of all evaluable subjects for DLT during the dose escalation phase, followed by DLT observation, and enters a efficacy exploration phase lasting up to 1 year. After safety conclusions are drawn for each group, investigators may choose to expand cases in the corresponding dose group based on treatment response, but the total number of cases should not exceed 12 (expanded cases are not subjected to DLT evaluation).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Aged ≥3 and ≤70 years, gender and race unrestricted. - Bone marrow examination confirms the diagnosis of acute B-cell lymphoblastic leukemia (B-ALL) and meets one of the following conditions: Relapsed B-ALL: ① Relapse within 12 months after the first remission; or ② Relapse after salvage chemotherapy in first-line/multi-line treatment; or ③ Relapse after autologous or allogeneic hematopoietic stem cell transplantation; Refractory B-ALL: ① Failure to achieve complete remission after 2 cycles of standardized induction chemotherapy; or ② Failure to achieve complete remission after salvage chemotherapy in first-line/multi-line treatment; - Ph+ALL subjects are eligible if they meet one of the following criteria: ① Relapse or refractory after receiving at least 2 tyrosine kinase inhibitors (TKIs) treatments; if accompanied by TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I, subjects are not required to receive at least two TKI treatments; or ② Unable to tolerate TKI treatment; or ③ Contraindications to TKI treatment. - The proportion of bone marrow blasts during the screening period is ≥5% (morphological).Expression of CD19 on bone marrow or peripheral blood tumor cells is detected during the screening period. - Organ function and laboratory tests meet the following criteria: Serum total bilirubin <2× upper limit of normal (ULN), serum ALT and AST both <3× ULN, serum creatinine <1.5× ULN; Coagulation function: International normalized ratio (INR) ≤1.5× ULN, or prothrombin time (PT) ≤1.5× ULN; Transthoracic echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; Resting oxygen saturation (SpO2) ≥92% in ambient air; Estimated survival period of more than 3 months; - ECOG score 0-2; - Fertile women must agree to use highly effective contraception from at least 28 days before leukapheresis to 6 months after CAR-T cell infusion. Their partners, fertile men, must agree to use effective barrier contraception from the start of leukapheresis to 6 months after CAR-T cell infusion, and should not donate semen or sperm during the entire trial period. Exclusion Criteria: - Suffering from genetic syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes; - History of allergy to any component of the cellular product; - Presence of active central nervous system leukemia (CNSL) at screening; - Patients with purely extramedullary relapse; - Received allogeneic hematopoietic stem cell transplantation (HSCT) within 3 months before screening or experienced grade II to IV active graft-versus-host disease (GVHD) within 4 weeks before infusion; - Significant cardiovascular dysfunction within 12 months before screening, including but not limited to: New York Heart Association (NYHA) class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias. Presence or suspicion of uncontrollable active infection requiring intravenous therapy (excluding simple urinary tract infections, bacterial pharyngitis); - Subjects with a history of other primary cancers, excluding the following: Non-melanoma skin cancers such as basal cell carcinoma that have been cured by resection; Cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ with disease-free survival ≥2 years after adequate treatment; - Subjects with autoimmune diseases requiring treatment, immunodeficiency, or requiring immunosuppressive therapy; - Received live attenuated vaccines within 4 weeks before screening, or planned to receive live attenuated vaccines during the study.

Gender: All

Minimum age: 3 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Anhui Provincial Hospital

Address:
City: Hefei
Zip: 230036
Country: China

Start date: March 15, 2024

Completion date: April 1, 2027

Lead sponsor:
Agency: Anhui Provincial Hospital
Agency class: Other

Source: Anhui Provincial Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06307600

Login to your account

Did you forget your password?