Acute Lymphoblastic LeukemiaEarly Phase 1NCT06659653

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

A Early Phase 1 study testing PRG2302 in people with Acute Lymphoblastic Leukemia, run by Tan Jie at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Acute Lymphoblastic Leukemia
What is being tested?: PRG2302
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteChina
Study dates: 24 May 2024to 31 Mar 2028
Phase: Early Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
1.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;

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3. Bone marrow or peripheral blood flow cytometry showed positive CD19 and/or CD22 leukemia cells;
4.The proportion of primitive and naive lymphocyte in bone marrow during screening period was ≥ 5%;
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)
2.0×ULN (Gilbert syndrome ≤ 3.0×ULN);
Blood oxygen saturation >92%;
Expected survival≥3 months;
ECOG score : 0~2;
Willing and signed informed consent.

Who cannot join

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);

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Organ failure patients:
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;
7.Any serious and/or uncontrollable comorbidities that the investigator believes may interfere with the assessment during the study;
8.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;
9.Donor lymphocyte infusion (DLI) was received within 4 weeks prior to anapheresis.
10.Live/attenuated vaccine was administered within 4 weeks prior to anapheresis or during the planned study period;
11.Major surgery or surgical treatment within 4 weeks for any reason;
12.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);
13.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;
14.Pregnant women and breastfeeding women cannot stop breastfeeding, and fertile men and their partners or women refuse to use effective contraceptive methods during the study period and at the end of the study (1 year after transfusion);In the researchers' judgment, a patient is fertile: he/she is biologically capable of having children and having a normal sexual life.Female patients who are infertile (i.e. meet at least 1 of the following criteria) : Have undergone hysterectomy or bilateral oophorectomy or bilateral tubal ligation, or have medically confirmed ovarian failure, or have medically confirmed postmenopause (at least 12 consecutive months of menopause);
15.Patients who cannot collect a sufficient number of mononuclear cells or T cells (e.g., failure to establish a collection pathway, collection failure, or low T cell proportion during screening);
16.Participated in other intervention clinical trials within 3 months;
17.Other medical conditions determined by the investigator to be unsuitable for lymphocyte clearance or cell infusion or other unsuitable participants for study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tan jie contact

18163137226

alooof@126.com

China1 site, 1 recruiting

The First People's Hospital of Jingzhou
Jinzhou, Hubei
Tan Jie, 18163137226, alooof@126.com
Recruiting

Other trials in China

About this study

Official title: Safety and Effectiveness of PRG2302 (CD19/CD22-targeting CAR-T Cells) for Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.

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
Being tested: PRG2302
Keywords: CAR-T
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRG2302Drug
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

Study groups in NCT06659653
Study group	Role	What they receive
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. Receives: Drug: PRG2302

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Up to 24 months after PRG-2302 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 202431 Mar 2028

First posted26 Oct 2024
Study start24 May 2024
Primary completion31 Mar 2027 (estimated)
Study completion31 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06659653
Sponsor's protocol ID: PRG2302
Status last verified: Oct 2024
First submitted: 5 Sep 2024
Last updated: 26 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effectiveness of PRG2302 (CD19/CD22-targeting CAR-T Cells) for Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.
ClinicalTrials.gov ID: NCT06659653
Acronym / sponsor ID: PRG2302
Conditions: Acute Lymphoblastic Leukemia
Keywords: CAR-T
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 18 participants (estimated)
Lead sponsor: Tan JieUniversity, hospital or other
Collaborators: Shenzhen Pregene Biopharma Co., Ltd.
Study start: 24 May 2024 (actual)
Primary completion: 31 Mar 2027 (estimated)
Study completion: 31 Mar 2028 (estimated)
First posted: 26 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CAR-T treatment	Experimental	Drug: PRG2302Plan 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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:

Key exclusion criteria (24 listed)

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;
According to the Wuhan Conference Classification (1983) to reach level III or above;
7.Any serious and/or uncontrollable comorbidities that the investigator believes may interfere with the assessment during the study;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PRG2302Dose 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	Drug	CAR-T treatment

Primary outcome

Safe dose of PRG-2302 infusion
Time frame: Up to 24 months after 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
Occurrence of AE after PRG-2302 infusion
Time frame: Up to 24 months after PRG-2302 infusion
To evaluate the occurrence of AE after PRG-2302 infusion based on CTCAE v5.0

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Tan jie contact

18163137226

alooof@126.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing PRG2302 in people with Acute Lymphoblastic Leukemia, run by Tan Jie at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tan jie (18163137226, alooof@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safe dose of PRG-2302 infusion (time frame: Up to 24 months after PRG-2302 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06659653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.