CClinicalTrials.gg
Status unknownNCT05340829Updated Apr 22, 2022

Evaluate the Safety and Effect of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lympholeukemia

A Phase 1 interventional study of ThisCART19A in AIDS Related Lymphoma and Lympholeukemia, sponsored by He Huang. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-22.

Sponsored by He Huang · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is an open label, phase I study to assess the safety and efficacy of ThisCART19A in patients with AIDS related B cell lymphoma/lympholeukemia.

02

Conditions studied

  • AIDS Related Lymphoma and Lympholeukemia
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 18 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

He Huang is the lead sponsor of 21 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-65.
  • Patients with AIDS-associated B-cell lymphoma/leukemia, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma tranferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and leukemia.
  • At least received first line treatment.
  • Had available evaluation lesion.
  • ECOG(Eastern Cooperative Oncology Group) ≤ 1 or Karnofsky ≥ 60%.
  • Had good organic function within 4 weeks before enrollment: Alanine aminotransferase(ALT)≤5×ULN(Upper limit of normal) and total bilirubin(TBIL)\<2.0 mg/dL(for patients with Gilbert heald diseases, live involvement and taking atazanavir or indinavir, TBIL\<3.0 mg/dL can be enrolled.); Left ventricular ejection fraction(LVEF)≥40%; Absolute neutrophile counts≥1000/mm3; thrombocyte≥30000/mm3; Serum creatinine≤1.5×ULN or creatinine clearance>30 mL/min/1.73 m2.
  • Confirmed Cluster of differentiation(CD)19 positive by biopsy for the patients who received CD19 target therapy before.
  • Confirmed Human immunodeficiency virus(HIV)-1 infection.
  • HIV virus loading \< 200 copy/ml within 4 weeks before screening.
  • CD4+T cell counts >50 cells/mm3 within 4 weeks before screening.
  • Patients with TBIL≤ 1.5 mg/dL, Aspartate aminotransferase(AST) and ALT ≤ 3×ULN, and hepatitis B virus(HBV) DNA \<2000 IU/ml can be enrolled for HBV positive patients(defined as hepatitis B virus surface antigen(HBsAg) positive and hepatitis B core(HBc)-total positive ) and hepatitis C virus(HCV) positive patients(defined as HCV antibody positive) . Patients with cirrhosis are excluded.
  • Hepatitis B core antibody(HBcAb) positive patients enrolled in this trial have to taking anti-HBV drugs during the whole research.

Exclusion criteria

Exclusion Criteria:

  • Known for allergic to the preconditioning measures.
  • Uncontrollable bacterial, fungal, viral infection before enrollment.
  • Patients with pulmonary embolism within 3 months prior enrollment.
  • Intolerable serious cardiovascular and cerebrovascular diseases and hereditary diseases.
  • Imaging confirmed the presence of central nervous system involvement(including primary and secondary) and rapid progressing diseases.
  • Receive allogeneic hematopoietic stem cell transplantation.
  • Systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. iIntermittent use of topical, inhaled or intranasal steroids recently or currently. Or systemic disease requiring long-term use of immunosuppression drugs.
  • Excluded the patients received Influenza vaccinations within 2 weeks prior to lymphodepletion (Received Severe Acute Respiratory Syndrome-Corona virus disease(SARS-COV)19 vaccines could be included. Received inactivated, live/non-live adjuvant vaccines could be enrolled).
  • Excluded women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after infusion. Male subjects planning pregnancy within 1 year after infusion should be excluded.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    ThisCART19A 2×10^6 cells/kg for dose level 1

    Patients will receive 2×10\^6 cells/kg of ThisCART19A

    Biological: ThisCART19A

  • Experimental
    ThisCART19A 3×10^6 cells/kg as dose level 2

    Patients will receive 3×10\^6 cells/kg of ThisCART19A

    Biological: ThisCART19A

  • Experimental
    Patients will receive 4×10^6 cells/kg as dose level 3

    Patients will receive 4×10\^6 cells/kg of ThisCART19A

    Biological: ThisCART19A

Interventions

  • BiologicalThisCART19A

    ThisCART19A is a new type CAR-T cells therapy for patients with lymphoma and lympholeukemia

06

What researchers measure

Primary outcomes

  1. Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level

    DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.

    Time frame: 28 days

Secondary outcomes

  1. Objective Response rate in patients with AIDS related lymphoma

    The incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment

    Time frame: 12 months

  2. The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion

    Track CAR-T cells expansion in patients after infusion

    Time frame: 6 months

  3. Analysis the change characteristics of cytokines and immune effect cells number in patients after infusion

    Analysis the effect cells and cytokines in patients after infusion

    Time frame: 3 months

  4. Analysis the severity and Incidence of Adverse Events in each dose level

    Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, the adverse events with special consideration

    Time frame: 12 months

  5. Analysis the immunogenicity(Anti-therapeutic antibody and neutralizing antibody) of CAR-T cells in patients after infusion

    Analysis the Anti-therapeutic antibody and neutralizing antibody level after infusion

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • The first affiliated hospital of medical college of zhejiang university
    Hangzhou, Zhejiang 310003, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05340829
Lead sponsor
He Huang
Responsible party
He Huang (President/Proffessor, Zhejiang University) — Sponsor-investigator
First posted
Apr 22, 2022
Start date
Mar 18, 2022
Primary completion
Mar 30, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Apr 22, 2022

Study contacts

Ming Ming Zhang, Doctor
Contact
mingmingzhang@zju.edu.cn
13656674208
He Huang, Doctor
principal investigator · First hospital affiliated Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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