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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3-70
SponsorAnhui Provincial Hospital

About this trial

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

Eligibility criteria

Qualifiers

Aged ≥3 and ≤70 years, gender and race unrestricted.

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.

ECOG score 0-2;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • RD06-03 cell injection

Treatment groups

9 Participants
are divided into 1 treatment group

Sponsors and collaborators