Safety and Efficacy of PRG-2302 for Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.

NCT06659653 | Recruiting Early Phase 1

• 1 other identifier: PRG2302
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

CAR-T

Outcome Measures

Primary Outcomes (2)

• Safe dose of PRG-2302 infusion

  To evaluate the safe dose of PRG-2302 infusion, 3 dosage group were designed in this trial, they are 0.5×10\^6 CAR-T,1.0×10\^6 CAR-T, and 2.0×10\^6 CAR-T

  Up to 24 months after PRG-2302 infusion

• Occurrence of AE after PRG-2302 infusion

  To evaluate the occurrence of AE after PRG-2302 infusion based on CTCAE v5.0

  Up to 24 months after PRG-2302 infusion

Study Arms (1)

CAR-T treatment

EXPERIMENTAL

Plan to design three dose levels (0.5x10\^6 CAR-T/kg ，1.0x10\^6 CAR-T/kg and 2.0x10\^6 CAR-T/kg ), with 3-6 R/R B-ALL subjects included in each dose group, totaling 9-18 subjects. Within each dose group, the next subject can be administered after the previous subject has completed at least 14 days of safety observation.

Drug: PRG2302

Interventions

PRG2302 DRUG

Dose group 1: with a dosage of 0.5x10\^6 (cells/kg) per dose Dose group 2: with a dosage of 1.0x10\^6 (cells/kg) per dose Dose group 3: with a dosage of 2.0x10\^6 (cells/kg) per dose

CAR-T treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, not over 70 years old (including 70 years old);
• Meet the following diagnostic criteria for recurrent or refractory B-ALL:
• A clear diagnosis of B-cell acute lymphoblastic leukemia with any of the following conditions Patients:
• recurrent: recurrence within 12 months after the first remission after standard treatment;
• refractory:
• induction No remission after more than 6 weeks of treatment or two courses of induction therapy; 2.Two or more CR or CRIs Later recurrence; 3.Relapse for the first time after chemotherapy and no remission after at least one salvage treatment; 4.Recurrence after autologous or allogeneic hematopoietic stem cell transplantation;
• \. Bone marrow or peripheral blood flow cytometry showed positive CD19 and/or CD22 leukemia cells;
• The proportion of primitive and naive lymphocyte in bone marrow during screening period was ≥ 5%;
• The functions of important organs are basically normal:
• Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;
• Renal function: creatinine clearance (CrCl) (Cockcroft-Gault formula, Appendix 4) ≥30mL/min;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0× upper limit of normal value (ULN);
• Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP)
• ×ULN (Gilbert syndrome ≤ 3.0×ULN);
• Blood oxygen saturation \>92%;

You may not qualify if:

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• Active central nervous system (CNS) leukemia (NCCN guidelines defined as CNS-3 grade and CNS-2 patients with neurological symptoms);
• Subjects with other malignancies within 5 years (except patients who have been cured and have no active disease for more than 3 years prior to screening, and patients with non-melanoma skin cancer, basal cell or squamous cell skin cancer, local prostate cancer, ductal carcinoma in situ, papillary or follicular thyroid cancer, and carcinoma in situ);
• Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA titer greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive; Peripheral blood tests positive for cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV);
• There is an uncontrolled active infection;
• Patients with clinically significant diseases of the central nervous system, such as epilepsy, cerebrovascular ischemia/bleeding history, cerebellar diseases or other organic brain syndromes or psychosis (except those with previous central invasion but improved after treatment);
• Organ failure patients:
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• Heart:
• a.New York Heart Association (NYHA) Stage III or IV congestive heart failure; b.Had a myocardial infarction or received coronary artery bypass grafting (CABG) or coronary stenting within 6 months or less before signing the ICF; c.A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those due to vasovagal or dehydration); d.History of severe non-ischemic cardiomyopathy;
• Liver:
• According to the Wuhan Conference Classification (1983) to reach level III or above;
• kidney: Renal insufficiency reaches stage III renal failure or above;
• Any serious and/or uncontrollable comorbidities that the investigator believes may interfere with the assessment during the study;
• Known allergic reactions, hypersensitivities, intolerances, or contraindications to any component of PRG2302 or the drugs that may be used in the study (including fludarabine, cyclophosphamide, tolumab, albumin), or prior severe allergic reactions;

Sponsors & Collaborators

• Tan Jie: lead
• Shenzhen Pregene Biopharma Co., Ltd.: collaborator

Study Sites (1)

The First People's Hospital of Jingzhou

Jinzhou, Hubei, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Tan jie

CONTACT

18163137226; alooof@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: October 26, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)