Safety and Efficacy of ThisCART22 in Patients With Refractory or Relapsed B Cell Malignancies

Fundamenta Therapeutics

Status and phase: Unknown; Phase 1

Conditions: B Cell Malignancy

Treatments: Biological: ThisCART22 cells injection

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04601181

ThisCART22

Details and patient eligibility

About

This is a single-center, nonrandomized, open-label, study to evaluate the safety and clinical activity of allogeneic CAR-T targeting CD22 in patients with refractory or relapsed CD22-positive B cell malignancies

Full description

The patients will receive infusion of ThisCART22 cells from health donor ,to evaluate the safety and efficacy of ThisCART22 Cells in patients with refractory or relapsed CD22-positive B cell malignancies.

In this study, the dose range is 0.2-60 x10^6 cells per kg body weight (no more than 3.0 x 10^9 in total).

Enrollment: 20 estimated patients

Sex: All

Ages: 3 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who volunteered to participate in the research and signed a written informed consent;

2. The informed consent was signed between the ages of 3-70, regardless of gender or race;

3. CD22 positive hematologic malignancies with no alternative treatment options deemed by investigator. including those who are not eligible for allogeneic stem cell transplantation (SCT) due to the following reasons： 3.1 age； 3.2 Concurrent disease； 3.3 Other contraindications, such as contraindications to total body irradiation (TBI) (TBI is one of the important treatment measures before allogeneic stem cell transplantation of ALL)； 3.4 Lack of suitable donors； 3.5 Patients with relapse after CD19-CAR T treatment；

4. Estimated life expectancy > 12 weeks deemed by investigator

5. Recurrence after any stem cell transplantation (regardless of previous treatment regimen);

6. Patients who relapse after previous allogeneic SCT (myeloablative or non-myeloablative) and meet all the following entry criteria:

   6.1 No active GVHD and no immunosuppression is required； 6.2 Transplant for more than 4 months；

7. Serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl；

8. Serum ALT/ AST < 5 upper limit of normal (ULN)；

9. Measurable or detectable disease at time of enrollment，include minimal residual disease (MRD) detected by immunotyping, cytogenetics or PCR.

10. Cardiac ejection fraction ≥ 40%.

11. Eastern cooperative oncology group (ECOG) performance status of ≤ 2.

12. Female subjects with fertility have a negative pregnancy test result within 48 hours before the infusion and are not breast-feeding; all subjects with fertility potential before being enrolled in the study and throughout the study period until the last infusion Within 3 months, take adequate contraceptive measures.

Exclusion criteria

1. Pregnant or lactating women;
2. Participated in another clinical trial during the first 4 weeks of the enrolled study or intended to participate in another clinical trial throughout the study period;
3. Have been treated with any gene product;
4. Uncontrolled infection;
5. History of HIV infection;
6. Active hepatitis B virus or hepatitis C virus infection;
7. Systemic steroid therapy may be required for cell infusion or collection, or there may be conditions that the investigator considers may require steroid therapy during blood collection or infusion.Corticosteroids for disease treatment are permitted, and inhaled steroids or hydrocortisone physiologic replacement therapy for patients with adrenocortical dysfunction is permitted beyond the time of cell collection or infusion;
8. Patients with grade 2-4 GVHD, or deemed need to manage by investigator;
9. The presence of GVHD under treatment;.
10. Patients with active CNS involvement by malignancy;
11. Patients combine with other disease cause neutrophil count (ANC) <750/uL or PLT< 50,000/uL
12. The researchers considered the subjects unsuitable for this clinical trial for various reasons.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ThisCART22 cells injection

Experimental group

Description:

In this arm，allogeneic anti-CD22 CAR T Cells(ThisCART22 cells) is used to treat patients with refractory or relapsed CD22 positive B cell malignancies.

Treatment:

Biological: ThisCART22 cells injection