Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Daratumumab

Immunoglobulins

Immunologic Factors

Recombinant anti-CD38 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.

A single dose (8 mg/kg) of HLX15 via intravenous infusion.

HLX15

A single dose (8 mg/kg) of US-sourced DARZALEX® via intravenous infusion.

US-sourced DARZALEX®

A single dose (8 mg/kg) of CN-sourced DARZALEX® via intravenous infusion.

CN-sourced DARZALEX®

A single dose (8 mg/kg) of EU-sourced DARZALEX® via intravenous infusion.

EU-sourced DARZALEX®

Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX15 with Daratumumab Injection in Healthy Chinese Male Subjects

This study contains two parts. Part I of the study is a single-center, randomized, open-label, 2-arm, parallel-controlled phase Ia study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX15 and daratumumab infusion (DARZALEX®, CN-sourced) in healthy Chinese male subjects.

A total of 24 healthy Chinese male subjects will be enrolled in this part and randomized to the HLX15 group or the CN-sourced DARZALEX® group in a 1:1 ratio, with 12 subjects in each group. The subjects will receive a single dose (8 mg/kg) of HLX15 or CN-sourced DARZALEX® via intravenous infusion.

There is a safety run-in period in the early stage of the study to investigate the safety and tolerability of HLX15 in healthy Chinese male subjects. Another 3-6 subjects will be enrolled to receive the investigational product HLX15 and safety observation will be conducted for 1 week. The Safety Review Committee (SRC) will decide whether to adjust the subsequent study plan based on the safety and tolerability data after administration.

Part II of the study is a multicenter, randomized, double-blind, 3-arm, parallel-controlled phase Ib study to compare similarity of the PK characteristics, safety, tolerability, and immunogenicity of HLX15 and daratumumab infusion (DARZALEX®, US-sourced; DARZALEX®, CN-sourced) in healthy Chinese male subjects.A total of 204 healthy Chinese male subjects are planned to be enrolled in this part and randomly assigned in a 1:1:1 ratio to the HLX15 group, the US-sourced DARZALEX® group, or the CN-sourced DARZALEX® group, with 68 subjects in each group. The subjects will receive a single dose (8 mg/kg) of HLX15, US-sourced DARZALEX®, or CN-sourced DARZALEX® via intravenous infusion.This part may be adjusted according to the results of Part I, including sample size and sampling time points

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects

A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX15 With Daratumumab Injection in Healthy Chinese Male Subjects

Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Shanghai Henlius Biotech

Symptoms and General Pathology

Leukemia

Cicatrix

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-Cell

Chronic Lymphocytic Leukemia

Patients who have relapsed and refractory B cell malignancies after chemotherapy will be treated with CD19 and CD20/CD22/CD30/CD38/CD70/CD123-specific gene-engineered T cells.

4SCAR19 and 4SCAR22

4SCAR19 and 4SCAR38

4SCAR19 and 4SCAR20

4SCAR19 and 4SCAR123

4SCAR19 and 4SCAR70

4SCAR19 and 4SCAR30

Lung-Ji Chang, PhD

Yuhua Li, M.D, Ph.D

Lihua Yang, M.D., Ph.D.

Xun Lai, MD

The study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Background:

T cells modified with lentiviral chimeric antigen receptor (CAR) gene have been studied in different clinical settings. Recent successes suggest that increased costimulatory signaling in the CAR design is critical for long term efficacy. Several clinical reports indicate that many patients still relapse and developed CD19-negative cancer cells after CD19 targeted therapy. Thus, to prevent the target escapes and improve the therapeutic effects, CAR gene-modified T cells targeting CD20, CD22, CD30, CD38, CD70 or CD123 are considered to apply together with CD19 CAR-T cells.

Activation of T cell response to high tumor burden may induce a severe response. To increase safety, a novel design using an inducible caspase 9 fusion gene has been incorporated in the CAR gene. A 4th generation CAR lentiviral vector (4SCAR) carrying multiple costimulatory signals for CD28/CD137/CD27 plus an inducible apoptotic caspase 9 gene has been established. This study aims to evaluate the activities of a combination of CAR gene-modified T cells to target cancer cells based on specific CD19/CD20/CD22/CD30/CD38/CD70/CD123 single chain antibody gene designs (4SCAR19/20/22/30/38/70/123).

Objective:

To evaluate safety and efficacy of administrating 4SCAR19, 4SCAR20, 4SCAR22, 4SCAR30, 4SCAR38, 4SCAR70 and 4SCAR123 T cells to patients with mixed CD19 positive and negative B cell malignancies following a cyclophosphamide/fludarabine based conditioning regimen.

Eligibility:

Patients older than 6-month-old with CD19 positive or negative B cell malignancies that have recurred after or refractory to standard therapy and is deemed incurable using standard treatment.

Design:

Participants will be screened based on cancer cell phenotype analyzed using flow cytometry or immunohistochemical staining methods. Peripheral blood mononuclear cells (PBMC) will be obtained through apheresis. On Day -5 to -7, T cells from PBMC will be activated and enriched, which will be followed by 4SCAR19, 4SCAR20, 4SCAR22, 4SCAR30, 4SCAR38, 4SCAR70 and 4SCAR123 lentiviral transduction. The total cell preparation time is approximately 5-7 days. Participants will receive a preparative conditioning regimen comprising cyclophosphamide/fludarabine to prepare their immune system to accommodate the modified CAR T cells. The preparative regimen will depend on the immune condition of patients, which is consistent with standard chemotherapy conditioning regimen. Participants will receive an infusion of the modified 4SCAR19 and 4SCAR20/22/30/38/70/123 T cells and closely followed up for treatment-related responses. Participants will be continuously monitored for CAR T cells and clinical responses in a preset timeline.

Combination CAR-T Cell Therapy Targeting Hematological Malignancies

Combination CAR-T Therapy of 4SCAR19 Plus 4SCAR20, 22, 38, 70 and 123 Targeting Hematological Malignancies

physiological parameter (for safety, measuring cytokine response, fever, symptoms)

scale of CAR copies and leukemic cell burden (for efficacy)

Shenzhen Geno-Immune Medical Institute

President

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Sarcoma

Lymphoma

Acquired Immunodeficiency Syndrome

HIV Infections

Sarcoma, Kaposi

Castleman Disease

Lymphoma, Primary Effusion

Lymphatic Diseases

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Soft Tissue Sarcoma

Lymphosarcoma

Kaposi Sarcoma

Unicentric Castleman Disease

Multicentric Castleman Disease

Primary Effusion Lymphoma

B-cell Lymphoma

Daratumumab SC (daratumumab and hyaluronidase) is administered subcutaneously (SC) as 1800 mg/30,000 units weekly for a total of 8 weeks (8 doses) followed by every 2 weeks for a total of 16 weeks (8 doses) followed by every 4 weeks for up to 96 weeks (24 doses)

Daratumumab SC

Anaida Widell

Kathryn A Lurain, M.D.

National Cancer Institute Referral Office

Background:

Primary effusion lymphoma (PEL) is an aggressive form of cancer that affects cells in the immune system and lymph nodes. How PEL develops is not well understood, and this disease does not respond well to standard treatments for other types of lymphomas.

Objective:

To test a drug treatment (daratumumab SC) in people with PEL.

Eligibility:

People aged 18 and older with PEL. Their PEL must have failed to respond to therapy or they must be unable to receive standard treatment for the disease.

Design:

Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart and lung function. They may need to have a biopsy: tissue or fluid will be collected. They will have an eye exam.

Daratumumab SC is given as an injection into the fat under the skin in the abdomen. This takes 3 to 5 minutes. Participants will receive the treatment once a week for 8 weeks; then every 2 weeks for 16 weeks; then every 4 weeks for up to 24 months.

Participants will have other tests during the study period. These may include lumbar punctures: A needle will be inserted between the bones of the spine to draw some fluid from the area around the spinal cord. Participants may also have a thoracentesis: A needle or plastic tube will be inserted into the space around the lungs to withdraw fluid. Participants will have more imaging scans and blood tests.

Follow-up visits will continue after treatment ends. Participants will be in the study for up to 5 years.

Background

* Primary effusion lymphoma (PEL) is an aggressive B cell lymphoma caused by the Kaposi sarcoma herpesvirus (KSHV) with clinicopathologic and molecular profiles distinct from other HIV-related lymphomas.
* Immunophenotypically, PEL is a post-germinal center B cell neoplasm expressing surface markers consistent with plasmacytic differentiation, such as CD45, CD38, CD138, MUM-1, and IRF4, similar to that of multiple myeloma.
* Outcomes for PEL treated with front-line combination chemotherapy are inferior to those of other HIV-associated lymphomas, and second-line cytotoxic chemotherapy is often ineffective and profound immunosuppression often prevents this approach.
* In the second-line setting, chemotherapy-sparing treatments that do not contribute to further immune suppression may be more effective. In addition, patients with PEL often have concurrent KS, which can be severely exacerbated by immune suppression and contributes to mortality in PEL.
* Kaposi sarcoma herpesvirus-associated multicentric Castleman disease (KSHV-MCD) is a rare lymphoproliferative disorder that develops predominantly in people with HIV with inflammatory symptoms associated with high levels of interleukin-6 (IL-6), KSHV-encoded viral IL-6 (vIL-6), and other cytokines.
* The pathologic hallmark of KSHV-MCD is the presence of KSHV-infected Lambda-restricted plasmablasts in the mantle zones of lymph nodes which stain brightly for CD45 and CD38 and negative for CD20.
* KSHV-MCD is generally treated with the anti-CD20 monoclonal antibody, rituximab, with the goal to rapidly improve symptoms and eliminate of reservoirs of KSHV-infected plasmablasts.
* Concurrent Kaposi sarcoma is often exacerbated by or develops during rituximab therapy and contributes to morbidity in KSHV-MCD.
* Daratumumab is a human monoclonal antibody that binds to a unique region on CD38 and induces killing of CD38-expressing cells via antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptosis.
* Daratumumab also depletes immunosuppressive non-plasma cells that express CD38 thereby reducing local immunosuppression and stimulating an increase in T-helper cells, cytotoxic T cells, T cell functional response, and TCR clonality in the tumor microenvironment.

Objective

-To evaluate the partial response (PR) plus complete response (CR) rate (further referred to as the overall response rate \[ORR\]) of daratumumab SC in participants with relapsed/refractory PEL and/or symptomatic KSHV-MCD or who are ineligible for frontline chemotherapy

Eligibility

* Age \>=18 years
* Pathologically confirmed relapsed and/or refractory primary effusion lymphoma (PEL), including extracavitary variant and KSHV-associated large cell lymphoma or ineligible for front line chemotherapy
* Participants with PEL must have:

  * Measurable or assessable disease
  * ECOG Performance Status (PS) 0-3
  * Received first-line curative-intent therapy for PEL, unless such therapy is contraindicated
* Participants with KSHV-MCD must have:

  * ECOG Performance Status (PS) 0-3
  * At least one clinical symptom and at least one laboratory abnormality attributable to KSHV-MCD

Design

* This is a Phase 2 study to evaluate the response rate of daratumumab SC in participants with relapsed/refractory PEL and/or symptomatic KSHV-MCD.
* The study will accrue up to 12 evaluable participants with PEL and up to 12 evaluable participants with KSHV-MCD.
* For participants with relapsed/refractory PEL, daratumumab SC will be administered subcutaneously (SC) as 1800 mg/30,000 units weekly for a total of 8 weeks (8 doses) followed by every 2 weeks for a total of 16 weeks (8 doses) followed by every 4 weeks for up to 96 weeks (24 doses) in the absence of off-treatment criteria.
* For participants with symptomatic KSHV-MCD, daratumumab SC will be administered SC as 1800 mg/30,000 units weekly for 8 weeks. If response assessment indicates progressive or stable disease, daratumumab SC will be given every 2 weeks for 8 additional doses for up to 24 weeks (6 months).

Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma

A Phase II Study of Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma and Multicentric Castleman Disease

Percentage of participants with the best overall response of CR or PR to therapy

Adverse events (AEs) will be reported by type and grade of toxicity

National Cancer Institute (NCI)

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Elotuzumab

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

FT538 monotherapy in subjects with r/r AML

FT538 in combination with daratumumab in subjects with r/r MM

FT538 in combination with elotuzumab in subjects with r/r MM

Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell

FT538

Fate Trial Disclosure

This is a Phase I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

FT538 in Subjects With Advanced Hematologic Malignancies

A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma

Proportion of subjects who achieve a CR, CRMRD-, CRi, MLFS, or PR, as determined by the investigator according to 2017 ELN criteria for AML, and the proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG for MM response criteria

Defined as the duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death due to progressive disease, as determined by the investigator according to standard IMWG response criteria

Defined as the time from first dose of study treatment to disease progression or relapse, or to the day of death from any cause, as determined by the investigator according to standard IMWG response criteria

Defined as the time from initial CR (including CRMRD-, CR, and CRi) to hematologic relapse or death due to any cause, as determined by the investigator according to 2017 ELN criteria for AML, and defined as the duration from the start of sCR or CR until the time of relapse from sCR or CR, as determined by the investigator according to standard IMWG response criteria for MM

defined as the time from first dose of lympho-conditioning to the date of PD, or relapse from CR or CRi, or death from any cause, according to 2017 ELN criteria

defined as the time from first dose of lympho-conditioning to death from any cause

defined as the time from first dose of lympho-conditioning to best response

The PK of FT538 in peripheral blood will be reported as the relative percentage of product (FT538) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points

Fate Therapeutics

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Lenalidomide

Pomalidomide

Dexamethasone acetate

Felzartamab

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Angiogenesis Inhibitors

Growth Inhibitors

Part A: MOR03087 dose escalation; biweekly treatment

Part B: MOR03087 dose escalation; weekly treatment

Part C: MOR03087 dose escalation (weekly treatment) + dexamethasone

Part D: MOR03087 weekly treatment in combination with pomalidomide + dexamethasone

Part E: MOR03087 weekly treatment in combination with lenalidomide + dexamethasone

For all parts, patients will be treated until disease progression (PD) or until a maximum of 3 years after first treatment.

Confirmatory cohorts of MOR03087 monotherapy (plus or minus dexamethasone), in combination with pomalidomide plus dexamethasone, and in combination with lenalidomide plus dexamethasone.

Following completion of Parts A, B, and C (dose escalation of MOR03087 biweekly and weekly schedules), the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen will be confirmed in a minimum of 6 subjects.

Following completion of Parts D (dose escalation of MOR03087 in combination with pomalidomide + dexamethasone) and E (dose escalation of MOR03087 in combination with lenalidomide + dexamethasone), the MTD and/or recommended dose in each part will be confirmed in a minimum of 6 subjects.

For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.

Treatment cycles will be 28 days. Initial MOR03087 doses will be 0.01 mg/kg in part A, 4 mg/kg in parts B and C and 8 mg/kg in parts D and E; in all parts MOR03087 doses will be escalated to a maximum of 16 mg/kg. In part A, patients will receive a biweekly intravenous infusion of MOR03087 which will be administered on days 1 and 15 of the cycle. In parts B to E patients will receive a weekly intravenous infusion of MOR03087 which will be administered on days 1, 8, 15, and 22 of the cycle.

In all parts a loading dose of MOR03087 will be additionally administered on day 4 of cycle 1.

MOR03087 phase 1 dose escalation

MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E.

MOR03087

Dexamethasone will be administered to patients orally; 40 mg (≤ 75 years old) or 20 mg (\> 75 years old) on days 1, 8, 15, and 22 of the 28-day cycle. An additional dose will be administered in cycle 1 on day 4.

Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle.

Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.

This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with relapsed/refractory multiple myeloma in combination with standard therapy.

The study enrolled patients aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher. Patients were assigned to the different treatment regimens with MOR202 ranging between 0·01 mg/kg and 16 mg/kg in a 3 + 3 design. Dose-escalation and expansion was done either with MOR202 intravenous infusions alone (MOR202 q2w \[twice a week\] and q1w \[weekly\] groups) or in combination with dexamethasone (MOR202 with dexamethasone group), with dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide group). Primary endpoints were safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity.

A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma

A Phase 1/2a, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD 38 Antibody MOR03087 as Monotherapy and in Combination With Standard Therapy in Subjects With Relapsed/Refractory Multiple Myeloma

1. as monotherapy
2. in combination with dexamethasone
3. in combination with pomalidomide + dexamethasone
4. in combination with lenalidomide + dexamethasone

Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity

number (#) of patients responding (# stringent complete response + # complete response + # very good partial response + # partial response)

Time to Progression (Kaplan Meier estimate)

Progression-free survival (Kaplan Meier estimates)

Duration of response (Kaplan Meier estimates)

PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups

MorphoSys AG

regular investigator assessment and laboratory testing

Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg

Part A: MOR03087 Biweekly Dose Escalation

Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.

MOR03087: MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E..

Part B: MOR03087 Weekly Dose Escalation

Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)

Part C: MOR03087 Plus Dexamethasone

Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.

Part D: MOR03087 Plus Pomalidomide + Dexamethasone

Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).

Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.

Part E: MOR03087 Plus Lenalidomide + Dexamethasone

Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg

Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.

Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).

Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Austria

Germany

Region of Enrollment

Dr Winrich Rauschning, Clinical Project Lead (external)

Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087

Number of Participants Who Develop Anti-MOR03087 Antibodies

Overall Response Rate

Time to Progression

Progression-free Survival

Of the total 91 patients, 26 obtained a response: 5 in part C, 10 in part D and 11 in part E. Duration of response was calculated only in these patients.

Duration of Response

Dosing at 4 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)

4 mg/kg QW

Dosing at 8 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)

8 mg/kg QW

Dosing at 16 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)

16 mg/kg QW

Pharmakokinetics was analysed on all available data on patients receiving 4mg/kg weekly, 8mg/kg weekly and 16 mg/kg weekly irrespective in which part the patients were treated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects	NCT05679258	Multiple Myelom...	HLX15 US-sourced DARZ... CN-sourced DARZ... EU-sourced DARZ...	18 Years - 60 Years	Shanghai Henlius Biotech
Combination CAR-T Cell Therapy Targeting Hematological Malignancies	NCT03125577	B-cell Malignan...	4SCAR19 and 4SC... 4SCAR19 and 4SC... 4SCAR19 and 4SC... 4SCAR19 and 4SC... 4SCAR19 and 4SC... 4SCAR19 and 4SC...	6 Months - 75 Years	Shenzhen Geno-Immune Medical Institute
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects	NCT05679258	Multiple Myelom...	HLX15 US-sourced DARZ... CN-sourced DARZ... EU-sourced DARZ...	18 Years - 60 Years	Shanghai Henlius Biotech
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma	NCT05907759	Lymphoma, Prima...	Daratumumab SC	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
FT538 in Subjects With Advanced Hematologic Malignancies	NCT04614636	Acute Myeloid L... AML, Adult Multiple Myelom... Myeloma	FT538 Cyclophosphamid... Fludarabine Daratumumab Elotuzumab	18 Years -	Fate Therapeutics
A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma	NCT01421186	Multiple Myelom...	MOR03087 phase ... MOR03087 Dexamethasone Pomalidomide Lenalidomide	18 Years -	MorphoSys AG
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects	NCT05679258	Multiple Myelom...	HLX15 US-sourced DARZ... CN-sourced DARZ... EU-sourced DARZ...	18 Years - 60 Years	Shanghai Henlius Biotech
A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma	NCT01421186	Multiple Myelom...	MOR03087 phase ... MOR03087 Dexamethasone Pomalidomide Lenalidomide	18 Years -	MorphoSys AG
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma	NCT05907759	Lymphoma, Prima...	Daratumumab SC	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
FT538 in Subjects With Advanced Hematologic Malignancies	NCT04614636	Acute Myeloid L... AML, Adult Multiple Myelom... Myeloma	FT538 Cyclophosphamid... Fludarabine Daratumumab Elotuzumab	18 Years -	Fate Therapeutics
A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)	NCT03984097	Multiple Myelom...	TAK-079 Lenalidomide Dexamethasone Bortezomib Pomalidomide	18 Years -	Takeda

Spots Global Cancer Trial Database for cd38

Every month we try and update this database with for cd38 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cd38

Every month we try and update this database with for cd38 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cd38 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.