NCT06081478RecruitingPhase 2
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 7 Oct 2023
- Start date
- 18 Jan 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Beijing Tongren Hospital
- NCT number
- NCT06081478
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 18 Jan 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previously treatment with any gene therapy products;
Other illness
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B or hepatitis C infection;
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
Lab values
- Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
Other
- Recent or current use of glucocorticoid or other immunosuppressor;
- Participate in other clinical research in the past three months;
- Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
Who the study is looking for
- 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.
Age in the registry: 14 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liang Wang Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.