OncoMatch/Clinical Trials/NCT06307600
The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia
Is NCT06307600 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies RD06-03 cell for b lymphoblastic leukemia/lymphoma.
Treatment: RD06-03 cell — This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CD19 expression (expression detected on bone marrow or peripheral blood tumor cells)
Expression of CD19 on bone marrow or peripheral blood tumor cells is detected during the screening period
Allowed: BCR ABL1 fusion (Ph+ALL)
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.
Allowed: ABL1 T315I/A
TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I
Allowed: ABL1 V299L
TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I
Allowed: ABL1 F317L/V/I/C
TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I
Allowed: ABL1 G250E
TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I
Allowed: ABL1 Y253H
TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I
Allowed: ABL1 E255K/V
TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I
Allowed: ABL1 F359V/C/I
TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — induction
Failure to achieve complete remission after 2 cycles of standardized induction chemotherapy
Must have received: salvage chemotherapy — first-line/multi-line
Failure to achieve complete remission after salvage chemotherapy in first-line/multi-line treatment
Must have received: autologous or allogeneic hematopoietic stem cell transplantation
Relapse after autologous or allogeneic hematopoietic stem cell transplantation
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: if received within 3 months before screening
Received allogeneic hematopoietic stem cell transplantation (HSCT) within 3 months before screening
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: if experienced grade II to IV active graft-versus-host disease (GVHD) within 4 weeks before infusion
experienced grade II to IV active graft-versus-host disease (GVHD) within 4 weeks before infusion
Lab requirements
Kidney function
serum creatinine <1.5× ULN
Liver function
Serum total bilirubin <2× ULN, serum ALT and AST both <3× ULN
Cardiac function
Transthoracic echocardiogram shows LVEF ≥50%
Serum total bilirubin <2× ULN, serum ALT and AST both <3× ULN, serum creatinine <1.5× ULN; INR ≤1.5× ULN, or PT ≤1.5× ULN; LVEF ≥50%; SpO2 ≥92% in ambient air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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