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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