OncoMatch/Clinical Trials/NCT06659653
Safety and Efficacy of PRG-2302 for Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.
Is NCT06659653 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies PRG2302 for acute lymphoblastic leukemia.
Treatment: PRG2302 — A Clinical Study on the Safety and Effectiveness of CD19/CD22 Chimeric Antigen Receptor T Cells in the Treatment of Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positive leukemia cells by flow cytometry (positive)
Bone marrow or peripheral blood flow cytometry showed positive CD19 and/or CD22 leukemia cells
Required: CD22 positive leukemia cells by flow cytometry (positive)
Bone marrow or peripheral blood flow cytometry showed positive CD19 and/or CD22 leukemia cells
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard treatment — induction, consolidation, or transplant
recurrent: recurrence within 12 months after the first remission after standard treatment; refractory: No remission after more than 6 weeks of treatment or two courses of induction therapy; Two or more CR or CRIs Later recurrence; Relapse for the first time after chemotherapy and no remission after at least one salvage treatment; Recurrence after autologous or allogeneic hematopoietic stem cell transplantation
Cannot have received: donor lymphocyte infusion
Donor lymphocyte infusion (DLI) was received within 4 weeks prior to anapheresis
Cannot have received: live/attenuated vaccine
Live/attenuated vaccine was administered within 4 weeks prior to anapheresis or during the planned study period
Cannot have received: major surgery
Major surgery or surgical treatment within 4 weeks for any reason
Cannot have received: allogeneic hematopoietic stem cell transplantation
Patients with a history of allogeneic hematopoietic stem cell transplantation in the 4 weeks prior to the collection, acute graft-versus-host disease (GvHD) or moderate-to-severe chronic grade 2 to 4 GvHD in the 4 weeks prior to collection, requiring systemic drug therapy (such as hormones or other immunosuppressants)
Cannot have received: high-dose chemotherapy
High doses of chemotherapy within 2 to 4 weeks, intrathecal therapy within 1 week, short-acting cytotoxic drugs, TKI and systemic glucocorticoid therapy within 3 days, or biologic drugs for disease treatment within 4 weeks
Cannot have received: other intervention clinical trial
Participated in other intervention clinical trials within 3 months
Lab requirements
Kidney function
creatinine clearance (CrCl) ≥30mL/min
Liver function
ALT and AST ≤3.0× ULN; TBIL and ALP ≤2.0× ULN (Gilbert syndrome ≤3.0× ULN)
Cardiac function
Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram
The functions of important organs are basically normal: 1. Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram; 2. Renal function: creatinine clearance (CrCl) ≥30mL/min; 3. ALT and AST ≤3.0× ULN; 4. TBIL and ALP ≤2.0× ULN (Gilbert syndrome ≤3.0× ULN); 5. Blood oxygen saturation >92%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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