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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06307600 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplantation, allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger and at least 3 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify