Relapsed/Refractory B-cell Acute Lymphoblastic LeukemiaPhase 1/2ADAPT-HEMNCT07523555
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
A Phase 1/2 study testing Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module and Autologous BCMA/CD19 dual-target CAR-T module in people with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, run by Beijing Biotech at 1 site in China.
Trial summary
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
- What is being tested?
- Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module and Autologous BCMA/CD19 dual-target CAR-T module
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 17 Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years at the time of consent.
- Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL/CLL/SLL; multiple myeloma/plasma cell leukemia; AML/high-risk MDS/BPDCN; or T-ALL/T-LBL/peripheral T-cell lymphoma.
- Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative/approved standard option judged appropriate by the investigator.
- Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review.
- Measurable or otherwise evaluable disease by disease-specific response criteria.
- ECOG performance status 0 to 2.
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- Adequate organ function: LVEF >= 45%; creatinine clearance >= 40 mL/min; AST/ALT <= 3 x ULN; total bilirubin <= 1.5 x ULN unless due to Gilbert syndrome; oxygen saturation >= 92% on room air.
- Adequate hematologic reserve unless cytopenia is clearly disease-related.
- Ability to undergo leukapheresis and willingness to comply with study procedures and follow-up.
- If prior allogeneic HSCT: at least 100 days from transplant, no uncontrolled GVHD, and no systemic immunosuppression above physiologic steroid replacement.
- Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception during protocol-defined risk periods.
- Written informed consent obtained before any study-specific procedure.
Who cannot join
- - Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.
- Active symptomatic CNS involvement requiring escalating therapy; previously treated/stable CNS disease may be allowed if defined prospectively in the final protocol.
- Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved >= Grade 3 toxicity from prior anticancer therapy
- Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.
- Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical/inhaled therapy.
- Prior solid organ transplant.
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- Clinically significant cardiovascular disease, uncontrolled arrhythmia, decompensated heart failure, myocardial infarction within 6 months, or recent stroke within 6 months.
- Uncontrolled HIV, HBV, or HCV viremia.
- Pregnancy or breastfeeding.
- Another active malignancy requiring systemic therapy, unless low-risk and definitively treated per protocol-defined exceptions.
- Known hypersensitivity to fludarabine, cyclophosphamide, or critical product excipients.
- Inability to manufacture a releaseable CAR-T product or failure to meet module-specific product-release criteria.
- Any medical, psychiatric, or social condition that, in the investigator's judgment, would increase risk, impair compliance, or confound interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: A Phase 1/2, Open-Label, Nonrandomized, Multi-arm Umbrella Study of Biomarker-Selected Dual-Target CAR-T Cell Modules in Adults With Relapsed or Refractory Hematologic Malignancies
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CD123, CD33/CLL1, or CD5/CD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response.
Lymphodepletion with fludarabine/cyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.
Read the detailed description
Rationale. Relapse after single-target CAR-T therapy is often driven by antigen down-regulation, lineage plasticity, or pre-existing subclonal heterogeneity. A dual-target framework attempts to preserve depth of response while lowering the probability of escape through loss of one surface antigen. This example therefore uses a master protocol with disease-specific target modules rather than a one-size-fits-all construct. Screening and target selection. All participants undergo central immunophenotyping on bone marrow, peripheral blood, and/or involved tissue within 21 days before enrollment. A module is considered eligible when both antigens are detected on malignant cells by validated flow cytometry or equivalent assay and the anticipated on-target/off-tumor risk is acceptable. If more than one module qualifies, the target selection committee ranks options by disease-specific biology, antigen density, prior antigen-directed therapy, predicted escape risk, and manufacturability.
Treatment schema. Participants undergo leukapheresis, optional bridging therapy, fludarabine/cyclophosphamide lymphodepletion, and infusion of the selected dual-target CAR-T module on Day 0.
Depending on the module, the dual-target strategy may be delivered as a tandem/bicistronic product, compound product, or predefined sequential paired infusion if that is safer or more manufacturable for that antigen pair. Participants are monitored intensively through Day 28, followed for efficacy through Month 24, and may enter long-term gene-modified cell safety follow-up for up to 15 years if required by the final regulatory strategy.
- Conditions
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm, BPDCN; Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma
- Being tested
- Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module, Autologous BCMA/CD19 dual-target CAR-T module, Autologous BCMA/CD38 dual-target CAR-T module, Autologous BCMA/GPRC5D dual-target CAR-T
- Keywords
- BCMA, biomarker-selected, CD19, CD20, CD22, CD33, CD38, CD123, CD5, CD7, CLL1/CLEC12A, dual-target CAR-T, GPRC5D, hematologic malignancy, MRD negativity, antigen escape, umbrella trial
- Medical subject headings
- Burkitt Lymphoma, Recurrence, Lymphoma, B-Cell, Multiple Myeloma, Leukemia, Plasma Cell, Leukemia, Myeloid, Acute, Blastic Plasmacytoid Dendritic Cell Neoplasm, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CD19/CD22 dual-target CAR-T moduleBiological
Biological: Autologous CD19/CD22 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.
Autologous CD19/CD20 dual-target CAR-T moduleBiological
Biological: Autologous CD19/CD20 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.
Autologous BCMA/CD19 dual-target CAR-T moduleBiological
Biological: Autologous BCMA/CD19 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.
Autologous BCMA/CD38 dual-target CAR-T moduleBiological
Biological: Autologous BCMA/CD38 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.
Autologous BCMA/GPRC5D dual-target CAR-TBiological
Biological: Autologous BCMA/GPRC5D dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide
Autologous CD33/CD123 dual-target CAR-T moduleBiological
Biological: Autologous CD33/CD123 dual-target CAR-T module (simultaneous or planned sequential paired infusion, module-specific) after lymphodepletion.
Autologous CD33/CLL1 dual-target CAR-T moduleBiological
Biological: Autologous CD33/CLL1 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide.
Autologous CD5/CD7 dual-target CAR-T moduleBiological
Biological: Autologous CD5/CD7 dual-target CAR-T module (including sequential paired infusion if needed for manufacturing/safety) after lymphodepletion.
| Study group | Role | What they receive |
|---|---|---|
| Arm A1 CD19/CD22 | Experimental | B-ALL, DLBCL, FL, MCL, PMBCL, CLL/SLL, or Richter transformation with confirmed CD19-positive / CD22-positive disease. Receives: Biological: Autologous CD19/CD22 dual-target CAR-T module |
| Arm A2 CD19/CD20 | Experimental | B-NHL or CLL/SLL with CD19-positive / CD20-positive disease, especially mature B-cell phenotype or relapse after prior CD19-directed therapy. Receives: Biological: Autologous CD19/CD20 dual-target CAR-T module |
| Arm B1 BCMA/CD19 | Experimental | Multiple myeloma or plasma cell leukemia with BCMA-positive disease plus evidence of a CD19-positive minor clone, precursor phenotype, or marked clonal heterogeneity. Receives: Biological: Autologous BCMA/CD19 dual-target CAR-T module |
| Arm B2 BCMA/CD38 | Experimental | Multiple myeloma or plasma cell leukemia with BCMA-positive / CD38-positive disease and a plasma-cell-dominant phenotype. Receives: Biological: Autologous BCMA/CD38 dual-target CAR-T module |
| Arm B3 BCMA/ GPRC5D | Experimental | Multiple myeloma or plasma cell leukemia with BCMA-positive / GPRC5D-positive disease, especially after prior BCMA exposure or with high escape risk. Receives: Biological: Autologous BCMA/GPRC5D dual-target CAR-T |
| Arm C1 CD33/CD123 | Experimental | AML, high-risk MDS, or BPDCN with CD33-positive / CD123-positive disease Receives: Biological: Autologous CD33/CD123 dual-target CAR-T module |
| Arm C2 CD33/CLL1 | Experimental | AML with CD33-positive / CLL1(CLEC12A)-positive disease, particularly stem-cell-rich or measurable residual disease patterns. Receives: Biological: Autologous CD33/CLL1 dual-target CAR-T module |
| Arm D1 CD5/CD7 | Experimental | T-ALL, T-LBL, or peripheral T-cell lymphoma with dual CD5-positive / CD7-positive expression and a feasible fratricide-mitigation plan. Receives: Biological: Autologous CD5/CD7 dual-target CAR-T module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) by module and dose level
Measured: 28 days
Incidence of Grade 3 or higher cytokine release syndrome (CRS)
Measured: 28 days
Secondary outcomes (4)
Complete response CR
Measured: 6 Months
MRD-negative response rate by validated disease-specific assay
Measured: 90 days
Duration of response (DoR)
Measured: 24 months
Overall survival (OS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start2 Mar 2026
- Primary completion14 Mar 2027 (estimated)
- Study completion17 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Biomarker-assigned umbrella study. Participants are assigned nonrandomly to 1 of 8 active dual-target modules based on diagnosis, antigen co-expression, prior target-directed therapy, and predicted safety. Each module uses an internal phase 1 dose-escalation run-in followed by phase 2 expansion at the RP2D. Modules may open or close adaptively after safety review; reserve pairs may be activated by amendment.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523555
- Sponsor's protocol ID
- EBI-ADAPT-HEM-103
- Acronym
- ADAPT-HEM
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Nonrandomized, Multi-arm Umbrella Study of Biomarker-Selected Dual-Target CAR-T Cell Modules in Adults With Relapsed or Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT07523555
- Acronym / sponsor ID
- ADAPT-HEM / EBI-ADAPT-HEM-103
- Conditions
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm, BPDCN; Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma
- Keywords
- BCMA, biomarker-selected, CD19, CD20, CD22, CD33, CD38, CD123
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Beijing BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 17 Feb 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CD123, CD33/CLL1, or CD5/CD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response.
Lymphodepletion with fludarabine/cyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.
Detailed description
Rationale. Relapse after single-target CAR-T therapy is often driven by antigen down-regulation, lineage plasticity, or pre-existing subclonal heterogeneity. A dual-target framework attempts to preserve depth of response while lowering the probability of escape through loss of one surface antigen. This example therefore uses a master protocol with disease-specific target modules rather than a one-size-fits-all construct. Screening and target selection. All participants undergo central immunophenotyping on bone marrow, peripheral blood, and/or involved tissue within 21 days before enrollment. A module is considered eligible when both antigens are detected on malignant cells by validated flow cytometry or equivalent assay and the anticipated on-target/off-tumor risk is acceptable. If more than one module qualifies, the target selection committee ranks options by disease-specific biology, antigen density, prior antigen-directed therapy, predicted escape risk, and manufacturability.
Treatment schema. Participants undergo leukapheresis, optional bridging therapy, fludarabine/cyclophosphamide lymphodepletion, and infusion of the selected dual-target CAR-T module on Day 0.
Depending on the module, the dual-target strategy may be delivered as a tandem/bicistronic product, compound product, or predefined sequential paired infusion if that is safer or more manufacturable for that antigen pair. Participants are monitored intensively through Day 28, followed for efficacy through Month 24, and may enter long-term gene-modified cell safety follow-up for up to 15 years if required by the final regulatory strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Biomarker-assigned umbrella study. Participants are assigned nonrandomly to 1 of 8 active dual-target modules based on diagnosis, antigen co-expression, prior target-directed therapy, and predicted safety. Each module uses an internal phase 1 dose-escalation run-in followed by phase 2 expansion at the RP2D. Modules may open or close adaptively after safety review; reserve pairs may be activated by amendment.
| Arm | Type | Receives |
|---|---|---|
| Arm A1 CD19/CD22 | Experimental | Biological: Autologous CD19/CD22 dual-target CAR-T moduleB-ALL, DLBCL, FL, MCL, PMBCL, CLL/SLL, or Richter transformation with confirmed CD19-positive / CD22-positive disease. |
| Arm A2 CD19/CD20 | Experimental | Biological: Autologous CD19/CD20 dual-target CAR-T moduleB-NHL or CLL/SLL with CD19-positive / CD20-positive disease, especially mature B-cell phenotype or relapse after prior CD19-directed therapy. |
| Arm B1 BCMA/CD19 | Experimental | Biological: Autologous BCMA/CD19 dual-target CAR-T moduleMultiple myeloma or plasma cell leukemia with BCMA-positive disease plus evidence of a CD19-positive minor clone, precursor phenotype, or marked clonal heterogeneity. |
| Arm B2 BCMA/CD38 | Experimental | Biological: Autologous BCMA/CD38 dual-target CAR-T moduleMultiple myeloma or plasma cell leukemia with BCMA-positive / CD38-positive disease and a plasma-cell-dominant phenotype. |
| Arm B3 BCMA/ GPRC5D | Experimental | Biological: Autologous BCMA/GPRC5D dual-target CAR-TMultiple myeloma or plasma cell leukemia with BCMA-positive / GPRC5D-positive disease, especially after prior BCMA exposure or with high escape risk. |
| Arm C1 CD33/CD123 | Experimental | Biological: Autologous CD33/CD123 dual-target CAR-T moduleAML, high-risk MDS, or BPDCN with CD33-positive / CD123-positive disease |
| Arm C2 CD33/CLL1 | Experimental | Biological: Autologous CD33/CLL1 dual-target CAR-T moduleAML with CD33-positive / CLL1(CLEC12A)-positive disease, particularly stem-cell-rich or measurable residual disease patterns. |
| Arm D1 CD5/CD7 | Experimental | Biological: Autologous CD5/CD7 dual-target CAR-T moduleT-ALL, T-LBL, or peripheral T-cell lymphoma with dual CD5-positive / CD7-positive expression and a feasible fratricide-mitigation plan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 to 75 years at the time of consent.
- Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL/CLL/SLL; multiple myeloma/plasma cell leukemia; AML/high-risk MDS/BPDCN; or T-ALL/T-LBL/peripheral T-cell lymphoma.
- Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative/approved standard option judged appropriate by the investigator.
- Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review.
- Measurable or otherwise evaluable disease by disease-specific response criteria.
Key exclusion criteria (13 listed)
- - Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.
- Active symptomatic CNS involvement requiring escalating therapy; previously treated/stable CNS disease may be allowed if defined prospectively in the final protocol.
- Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved >= Grade 3 toxicity from prior anticancer therapy
- Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.
- Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical/inhaled therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous CD19/CD22 dual-target CAR-T moduleBiological: Autologous CD19/CD22 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide. | Biological | Arm A1 CD19/CD22 |
| Autologous CD19/CD20 dual-target CAR-T moduleBiological: Autologous CD19/CD20 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide. | Biological | Arm A2 CD19/CD20 |
| Autologous BCMA/CD19 dual-target CAR-T moduleBiological: Autologous BCMA/CD19 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide. | Biological | Arm B1 BCMA/CD19 |
| Autologous BCMA/CD38 dual-target CAR-T moduleBiological: Autologous BCMA/CD38 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide. | Biological | Arm B2 BCMA/CD38 |
| Autologous BCMA/GPRC5D dual-target CAR-TBiological: Autologous BCMA/GPRC5D dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide | Biological | Arm B3 BCMA/ GPRC5D |
| Autologous CD33/CD123 dual-target CAR-T moduleBiological: Autologous CD33/CD123 dual-target CAR-T module (simultaneous or planned sequential paired infusion, module-specific) after lymphodepletion. | Biological | Arm C1 CD33/CD123 |
| Autologous CD33/CLL1 dual-target CAR-T moduleBiological: Autologous CD33/CLL1 dual-target CAR-T module after lymphodepletion with fludarabine/cyclophosphamide. | Biological | Arm C2 CD33/CLL1 |
| Autologous CD5/CD7 dual-target CAR-T moduleBiological: Autologous CD5/CD7 dual-target CAR-T module (including sequential paired infusion if needed for manufacturing/safety) after lymphodepletion. | Biological | Arm D1 CD5/CD7 |
Primary outcome
Incidence of dose-limiting toxicities (DLTs) by module and dose level
Time frame: 28 days
Incidence of Grade 3 or higher cytokine release syndrome (CRS)
Time frame: 28 days
4 secondary outcomes
Complete response CR
Time frame: 6 Months
MRD-negative response rate by validated disease-specific assay
Time frame: 90 days
Duration of response (DoR)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module and Autologous BCMA/CD19 dual-target CAR-T module in people with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, run by Beijing Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shan S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) by module and dose level (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.