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RecruitingEarly Phase 1NCT06307600

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

The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With Relapsed or Refractory B-lymphoblastic Leukemia

Sponsor

Anhui Provincial Hospital

Enrollment

9 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

B Lymphoblastic Leukemia/Lymphoma

Summary

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

Eligibility

Min Age: 3 YearsMax Age: 70 Years

Inclusion Criteria9

  • 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 Criteria11

  • 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.

Interventions

DRUGRD06-03 cell injection

The patients in this intervention will use RD06-03 cell injection with 3 dose dose 1: 1×10\^5 CAR+ T Cells/kg dose 2: 3×10\^5 CAR+ T Cells/kg dose 3: 5×10\^5 CAR+ T Cells/kg Dosage form: IV injection Frequency of administration：1 time

Locations(2)

Anhui Provincial Hospital

Hefei, Anhui, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06307600