Clinical trial NCT06081478: CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
Official title: CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia: a Prospective, Single-arm, Single-center, Phase 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: B-cell Acute Lymphoblastic Leukemia
B-cell Lymphoma
Diffuse Large B Cell Lymphoma
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* 14 years to 85 years, expected survival \> 3 months;
* CD19/CD22 positive B-cell lymphoma or B-ALL;
* relapsed or refractory to standard first-line treatment;
* ECOG-PS score=0-2;
* Having at least one measurable lesions;
* Cardiac function: 1-2 levels;
* Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
* kidney: Cr≤1.25ULN;
* bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
* No serious allergic constitution;
* No other serious diseases that conflicts with the clinical program;
* No other cancer history;
* No serious mental disorder;
* Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

* Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
* Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
* Active hepatitis B or hepatitis C infection;
* Recent or current use of glucocorticoid or other immunosuppressor;
* With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
* Participate in other clinical research in the past three months;
* previously treatment with any gene therapy products;
* Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.

Primary outcomes:
measure: Best ORR
timeFrame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Secondary outcomes:
measure: Best CR rate
timeFrame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
measure: Progression free survival (PFS)
timeFrame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
measure: overall survival (OS)
timeFrame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Liang Wang
state: Beijing
Study officials:
References: