New CAR-T therapy shows promise for lymphoma patients who relapsed after prior treatment
NCT ID NCT04316624
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new cell therapy called C-CAR066 in 7 people with diffuse large B-cell lymphoma whose cancer had returned after CD19 CAR-T treatment. The therapy uses the patient's own immune cells, modified to target a different protein (CD20) on cancer cells. The main goals were to check safety and see if the treatment could shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- C-CAR066 (a type of CAR-T cell therapy that targets CD20 on cancer cells)
- What this could lead to
- If successful, this could offer a new treatment option for people with diffuse large B-cell lymphoma whose cancer returned after CD19 CAR-T therapy.
- What could go wrong
- This is a very early, small Phase 1 trial with only 7 participants, so results may not apply widely. CAR-T therapies can cause serious side effects like cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
7 people
The number who actually took part.
- Started
-
Sep 2019
- Finished
-
Feb 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The patient volunteered to participate in the study, and signed the Informed Consent 2. Age 18-75 years old, male or female 3. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm) 4. r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20 5. At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis 6. Adequate organ and bone marrow fuction 7. No contraindications of apheresis 8. Expected survival time \> 3 months 9. ECOG scores 0 - 1 Exclusion Criteria: 1. Have a history of allergy to cellular products 2. Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard 3. A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease 4. Patients with active CNS involvement 5. Patients with autoimmune disease, immunodeficiency, or other treatment requiring inhibitors 6. Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed 7. Live vaccination within 4 weeks before peripheral blood apheresis 8. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers 9. Have a history of alcoholism, drug addiction and mental illness 10. Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception 11. Patients with severe fludarabine or cyclophosphamide hypersensitivity 12. The patient has a history of other primary cancers, except for the following: 1. Non-melanoma such as skin basal cell carcinoma cured by resection 2. Cured carcinoma in situ such as cervical, bladder or breast cancer 13. The investigators believe that there are other circumstances that are not suitable for the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020, China
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