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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06659653 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior donor lymphocyte infusion, live/attenuated vaccine, major surgery disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive leukemia cells by flow cytometry is a required biomarker for enrollment.
Does this trial require CD22?
Yes, CD22 positive leukemia cells by flow cytometry is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
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 qualifyRelated pages